TriangleNCT02008227 · STUDY IN CONTEXT
A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Percentage of Participants Who Died: PP-ITT
Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in \>/=1% and \<5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in \>/=5% and \<50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in \>/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between \>/=1% and \<5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between \>/=5% and \<10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering \>/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.
PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0015
- source section id
- NCT02008227-om-0015
- source outcome index
- 15
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
- measure definition
- TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A \>/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0016
- source section id
- NCT02008227-om-0016
- source outcome index
- 16
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
- measure definition
- EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0017
- source section id
- NCT02008227-om-0017
- source outcome index
- 17
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-C30 Questionnaire Score: Functional Subscales
- measure definition
- EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-C30 Questionnaire Score: GHS Scale
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0018
- source section id
- NCT02008227-om-0018
- source outcome index
- 18
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-C30 Questionnaire Score: GHS Scale
- measure definition
- EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0019
- source section id
- NCT02008227-om-0019
- source outcome index
- 19
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
- measure definition
- EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-LC13 Questionnaire Score: Alopecia
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0020
- source section id
- NCT02008227-om-0020
- source outcome index
- 20
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Alopecia
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-LC13 Questionnaire Score: Coughing
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0021
- source section id
- NCT02008227-om-0021
- source outcome index
- 21
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Coughing
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0022
- source section id
- NCT02008227-om-0022
- source outcome index
- 22
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Dysphagia
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0023
- source section id
- NCT02008227-om-0023
- source outcome index
- 23
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Dyspnea
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0024
- source section id
- NCT02008227-om-0024
- source outcome index
- 24
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0025
- source section id
- NCT02008227-om-0025
- source outcome index
- 25
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0026
- source section id
- NCT02008227-om-0026
- source outcome index
- 26
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0027
- source section id
- NCT02008227-om-0027
- source outcome index
- 27
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0028
- source section id
- NCT02008227-om-0028
- source outcome index
- 28
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0029
- source section id
- NCT02008227-om-0029
- source outcome index
- 29
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- trial label
- A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 15
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0000
- source section id
- NCT02008227-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants Who Died: PP-ITT
- endpoint definition
- Percentage of Participants Who Died: PP-ITT
- time origin
- Baseline until death due to any cause (up to approximately 2.25 years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PP-ITT analysis set included the first 850 randomized ITT participants regardless of whether they received any study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0001
- source section id
- NCT02008227-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
- endpoint definition
- Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in \>/=1% and \<5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in \>/=5% and \<50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in \>/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between \>/=1% and \<5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between \>/=5% and \<10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering \>/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.
- time origin
- Baseline until death due to any cause (up to approximately 2.25 years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- TC1/2/3 or IC1/2/3 subgroup within PP included ITT participants with the corresponding programmed death-ligand 1 (PD-L1) expression status.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0002
- source section id
- NCT02008227-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival (OS): PP-ITT
- endpoint definition
- OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
- time origin
- Baseline until death due to any cause (up to approximately 2.25 years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PP-ITT analysis set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0003
- source section id
- NCT02008227-om-0003
- source outcome index
- 3
- endpoint
- OS: TC1/2/3 or IC1/2/3 Subgroup of PP
- endpoint definition
- OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
- time origin
- Baseline until death due to any cause (up to approximately 2.25 years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- TC1/2/3 or IC1/2/3 subgroup of PP
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0004
- source section id
- NCT02008227-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT
- endpoint definition
- PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.
- time origin
- Baseline up to PD or Death (up to approximately 2.25 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PP-ITT analysis set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0005
- source section id
- NCT02008227-om-0005
- source outcome index
- 5
- endpoint
- Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP
- endpoint definition
- PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
- time origin
- Baseline up to PD or Death (up to approximately 2.25 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- TC1/2/3 or IC1/2/3 subgroup of PP
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Docetaxel
- regimen
- Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 425
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Atezolizumab
- regimen
- Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 425
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Docetaxel
- regimen
- Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Atezolizumab
- regimen
- Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 241
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Docetaxel
- regimen
- Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 425
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Atezolizumab
- regimen
- Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 425
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Docetaxel
- regimen
- Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Atezolizumab
- regimen
- Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 241
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Docetaxel
- regimen
- Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 425
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Atezolizumab
- regimen
- Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 425
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Docetaxel
- regimen
- Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Atezolizumab
- regimen
- Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
- analyzed count
- 241
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02008227-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- harm key
- EG000
- source section id
- NCT02008227-ae
- event group key
- EG000
- event group label
- Docetaxel
- serious affected
- 180
- serious at risk
- 578
- other affected
- 535
- other at risk
- 578
- frequency threshold
- 5
- collection period
- Baseline up to approximately 5.28 years.
- event definition
- Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- harm key
- EG001
- source section id
- NCT02008227-ae
- event group key
- EG001
- event group label
- Atezolizumab
- serious affected
- 200
- serious at risk
- 609
- other affected
- 541
- other at risk
- 609
- frequency threshold
- 5
- collection period
- Baseline up to approximately 5.28 years.
- event definition
- Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0015
- source section id
- NCT02008227-om-0015
- source outcome index
- 15
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
- measure definition
- TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A \>/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0016
- source section id
- NCT02008227-om-0016
- source outcome index
- 16
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
- measure definition
- EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0017
- source section id
- NCT02008227-om-0017
- source outcome index
- 17
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-C30 Questionnaire Score: Functional Subscales
- measure definition
- EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0018
- source section id
- NCT02008227-om-0018
- source outcome index
- 18
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-C30 Questionnaire Score: GHS Scale
- measure definition
- EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0019
- source section id
- NCT02008227-om-0019
- source outcome index
- 19
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
- measure definition
- EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0020
- source section id
- NCT02008227-om-0020
- source outcome index
- 20
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Alopecia
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0021
- source section id
- NCT02008227-om-0021
- source outcome index
- 21
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Coughing
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0022
- source section id
- NCT02008227-om-0022
- source outcome index
- 22
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Dysphagia
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0023
- source section id
- NCT02008227-om-0023
- source outcome index
- 23
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Dyspnea
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0024
- source section id
- NCT02008227-om-0024
- source outcome index
- 24
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0025
- source section id
- NCT02008227-om-0025
- source outcome index
- 25
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-jobevne-0af77ec0
- nct id
- NCT02008227
- qol key
- qol-0026
- source section id
- NCT02008227-om-0026
- source outcome index
- 26
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
- measure definition
- QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.
- time frame
- Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice