TriangleNCT02477826 · STUDY IN CONTEXT
An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Pa
Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
OS for all randomized participants is the time between randomization date and the date of death from any cause.
Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- qol key
- qol-0003
- source section id
- NCT02477826-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
- measure definition
- The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
- time frame
- Week 12
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- trial label
- An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Pa
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent 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
- 4
- harms Count
- 10
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- source section id
- NCT02477826-om-0000
- source outcome index
- 0
- endpoint
- Progression-Free Survival Per BICR
- endpoint definition
- Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- time origin
- From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0001
- source section id
- NCT02477826-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- OS for all randomized participants is the time between randomization date and the date of death from any cause.
- time origin
- From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0002
- source section id
- NCT02477826-om-0002
- source outcome index
- 2
- endpoint
- Objective Response Rate (ORR) Per BICR
- endpoint definition
- Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- time origin
- From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0003
- source section id
- NCT02477826-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
- endpoint definition
- The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
- time origin
- Week 12
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part 1-Arm B: Nivo + Ipi
- regimen
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 396
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part 1-Arm A: Nivolumab
- regimen
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 396
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Part 1-Arm C: Chemotherapy
- regimen
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- analyzed count
- 397
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Part 1-Arm D: Nivo + Ipi
- regimen
- Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 187
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Part 1-Arm G: Nivo + Chemo
- regimen
- Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- analyzed count
- 177
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Part 1-Arm F: Chemotherapy
- regimen
- Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- analyzed count
- 186
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Part 2 - Arm H: Nivolumab + Chemotherapy
- regimen
- Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- analyzed count
- 377
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Part 2 - Arm I: Chemotherapy
- regimen
- Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- analyzed count
- 378
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- arm key
- OG008
- arm label
- Part 3 -Arm J: Nivolumab + Ipilimumab
- regimen
- Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 126
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0000#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0000
- arm key
- OG009
- arm label
- Part 3 - Arm K: Chemotherapy
- regimen
- Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- analyzed count
- 127
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0000#groups/OG009
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part 1-Arm B: Nivo + Ipi
- regimen
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 396
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part 1-Arm A: Nivolumab
- regimen
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 396
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02477826-om-0001#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- harm key
- EG000
- source section id
- NCT02477826-ae
- event group key
- EG000
- event group label
- Part 1-Arm B: Nivo + Ipi
- serious affected
- 275
- serious at risk
- 391
- other affected
- 366
- other at risk
- 391
- frequency threshold
- 5
- collection period
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- event definition
- Randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- harm key
- EG001
- source section id
- NCT02477826-ae
- event group key
- EG001
- event group label
- Part 1-Arm A: Nivolumab
- serious affected
- 239
- serious at risk
- 391
- other affected
- 356
- other at risk
- 391
- frequency threshold
- 5
- collection period
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- event definition
- Randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- harm key
- EG002
- source section id
- NCT02477826-ae
- event group key
- EG002
- event group label
- Part 1-Arm C: Chemotherapy
- serious affected
- 213
- serious at risk
- 387
- other affected
- 361
- other at risk
- 387
- frequency threshold
- 5
- collection period
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- event definition
- Randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- harm key
- EG003
- source section id
- NCT02477826-ae
- event group key
- EG003
- event group label
- Part 1-Arm D: Nivo + Ipi
- serious affected
- 128
- serious at risk
- 185
- other affected
- 172
- other at risk
- 185
- frequency threshold
- 5
- collection period
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- event definition
- Randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- harm key
- EG004
- source section id
- NCT02477826-ae
- event group key
- EG004
- event group label
- Part 1-Arm G: Nivo + Chemo
- serious affected
- 112
- serious at risk
- 172
- other affected
- 167
- other at risk
- 172
- frequency threshold
- 5
- collection period
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- event definition
- Randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- harm key
- EG005
- source section id
- NCT02477826-ae
- event group key
- EG005
- event group label
- Part 1-Arm F: Chemotherapy
- serious affected
- 91
- serious at risk
- 183
- other affected
- 165
- other at risk
- 183
- frequency threshold
- 5
- collection period
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- event definition
- Randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- harm key
- EG006
- source section id
- NCT02477826-ae
- event group key
- EG006
- event group label
- Part 2 - Arm H: Nivolumab + Chemotherapy
- serious affected
- 240
- serious at risk
- 375
- other affected
- 357
- other at risk
- 375
- frequency threshold
- 5
- collection period
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- event definition
- Randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- harm key
- EG007
- source section id
- NCT02477826-ae
- event group key
- EG007
- event group label
- Part 2 - Arm I: Chemotherapy
- serious affected
- 180
- serious at risk
- 371
- other affected
- 345
- other at risk
- 371
- frequency threshold
- 5
- collection period
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- event definition
- Randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- harm key
- EG008
- source section id
- NCT02477826-ae
- event group key
- EG008
- event group label
- Part 3 -Arm J: Nivolumab + Ipilimumab
- serious affected
- 78
- serious at risk
- 126
- other affected
- 124
- other at risk
- 126
- frequency threshold
- 5
- collection period
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- event definition
- Randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- harm key
- EG009
- source section id
- NCT02477826-ae
- event group key
- EG009
- event group label
- Part 3 - Arm K: Chemotherapy
- serious affected
- 60
- serious at risk
- 123
- other affected
- 121
- other at risk
- 123
- frequency threshold
- 5
- collection period
- Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
- event definition
- Randomized participants
- 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-stage-iv-recurrent-064adc80
- nct id
- NCT02477826
- qol key
- qol-0003
- source section id
- NCT02477826-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
- measure definition
- The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
- time frame
- Week 12
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All randomized participants
- 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