TriangleNCT03052608 · STUDY IN CONTEXT
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
Draft scope assessment: unclear. Attached because the study's own record names ALK. 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
PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by the independent radiologist or death due to any cause, whichever occurred first. PFS (in months) was calculated as (date of event or censoring-randomization+1)/30.4375. Progressive disease is defined per RECIST version 1.1, as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.
OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death or censoring - start date +1)/30.4375. Participants last known to be alive were censored at date of last contact.
PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by investigator or death due to any cause, whichever occurred first. PFS (in months) was calculated as (date of event or censoring-randomization+1)/30.4375. Progressive disease is defined per RECIST version 1.1, as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.
ORR was the percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
ORR was the percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
IC-ORR was the percentage of participant with intracranial objective response of complete response (CR) or partial response (PR) based on intracranial disease in the subset of participants with at least 1 intracranial lesion per RECIST version 1.1 (modified) recorded from randomization until disease progression or start of new anti-cancer therapy. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Change From Baseline in Global Quality of Life (QOL), Functional Scales and Symptoms Scales as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) During Overall Treatment
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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- qol key
- qol-0021
- source section id
- NCT03052608-om-0021
- source outcome index
- 21
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change From Baseline in Global Quality of Life (QOL), Functional Scales and Symptoms Scales as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) During Overall Treatment
- measure definition
- The EORTC QLQ C30 consists of 30 questions and includes 5 functional scales (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale; 3 symptom scales (fatigue, pain, nausea and vomiting); and 6 single items that assess additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial impact. All scales and single item measures range in score from 0 to 100. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms.
- time frame
- From Baseline up to Cycle 38 Day 1
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants from the FA population who completed a baseline (last patient-reported outcome (PRO) assessment prior to the first dose of study treatment) and at least 1 post-baseline PRO assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Change From Baseline in Lung Cancer Symptoms as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) During Overall Treatment
Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- qol key
- qol-0022
- source section id
- NCT03052608-om-0022
- source outcome index
- 22
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change From Baseline in Lung Cancer Symptoms as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) During Overall Treatment
- measure definition
- The EORTC QLQ LC13 consists of 13 questions and includes 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The scale scores rang from 0 to 100, with higher scores indicating higher ("worse") level of symptoms.
- time frame
- From Baseline up to Cycle 38 Day 1
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher scores indicating higher ("worse
- population note
- Participants from the FA population who completed a baseline (last patient-reported outcome (PRO) assessment prior to the first dose of study treatment) and at least 1 post-baseline PRO assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EQ-5D · Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Visual Analogue Scale (VAS) Across Time
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- qol key
- qol-0023
- source section id
- NCT03052608-om-0023
- source outcome index
- 23
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Visual Analogue Scale (VAS) Across Time
- measure definition
- The EuroQol EQ-5D-5L is a participant-completed questionnaire designed to assess health status. There are 2 components to the EuroQol EQ-5D-5L: a descriptive system in which individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a VAS. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) and higher scores indicate better health state.
- time frame
- Baseline, Day 1 of all cycles from Cycle 2 to Cycle 38, and End of Treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicate better
- population note
- "Number of Participants Analyzed" included all participants in the EQ-5D-5L PRO analysis population within each treatment group. "Number Analyzed" included all participants with at least a baseline and postbaseline assessment at the visit.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EQ-5D · Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Index Across Time
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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- qol key
- qol-0024
- source section id
- NCT03052608-om-0024
- source outcome index
- 24
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Index Across Time
- measure definition
- The EuroQol EQ-5D-5L is a participant-completed questionnaire designed to assess health status. There are 2 components to the EuroQol EQ-5D-5L: a descriptive system in which individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a VAS in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
- time frame
- Baseline, Day 1 of all cycles from Cycle 2 to Cycle 38, and End of Treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- "Number of Participants Analyzed" included all participants in the PRO analysis population within each treatment group. "Number Analyzed" included all participants with at least a baseline and postbaseline assessment at the visit.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Time to Deterioration (TTD) in Participant Reported Pain in Chest, Dyspnea, or Cough From QLQ-LC13
Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- qol key
- qol-0025
- source section id
- NCT03052608-om-0025
- source outcome index
- 25
- instrument
- EORTC QLQ
- instrument basis
- matched 'qlq' in the study's own wording
- scale title
- Time to Deterioration (TTD) in Participant Reported Pain in Chest, Dyspnea, or Cough From QLQ-LC13
- measure definition
- The EORTC QLQ LC13 consists of 13 questions and includes 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The scale scores rang from 0 to 100, with higher scores indicating higher ("worse") level of symptoms. TTD in pain in chest, dyspnea, or cough was defined as the time from randomization to the first time the participant's score showed a 10 point or greater increase after baseline in any of the 3 symptoms. TTD in months was calculated as (date of deterioration or censoring - randomization date +1)/30.4375.
- time frame
- From Baseline up to 33 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher scores indicating higher ("worse
- population note
- Participants in the EORTC QLQ-LC13 PRO analysis population with change from baseline scores within each treatment group and subscale.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- trial label
- A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
- applicability
- unclear
- applicability note
- Attached because the study's own record names ALK. 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
- 5
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0000
- source section id
- NCT03052608-om-0000
- source outcome index
- 0
- endpoint
- Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment
- endpoint definition
- PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by the independent radiologist or death due to any cause, whichever occurred first. PFS (in months) was calculated as (date of event or censoring-randomization+1)/30.4375. Progressive disease is defined per RECIST version 1.1, as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.
- time origin
- From time of Study Start up to 33 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The full analysis (FA) population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0001
- source section id
- NCT03052608-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death or censoring - start date +1)/30.4375. Participants last known to be alive were censored at date of last contact.
- time origin
- From time of Study Start up to 33 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0002
- source section id
- NCT03052608-om-0002
- source outcome index
- 2
- endpoint
- Progression-Free Survival (PFS) Based on Investigator's Assessment
- endpoint definition
- PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by investigator or death due to any cause, whichever occurred first. PFS (in months) was calculated as (date of event or censoring-randomization+1)/30.4375. Progressive disease is defined per RECIST version 1.1, as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.
- time origin
- From time of Study Start up to 33 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0003
- source section id
- NCT03052608-om-0003
- source outcome index
- 3
- endpoint
- Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on BICR Assessment
- endpoint definition
- ORR was the percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
- time origin
- From time of Study Start up to 33 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0004
- source section id
- NCT03052608-om-0004
- source outcome index
- 4
- endpoint
- Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on Investigator's Assessment
- endpoint definition
- ORR was the percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
- time origin
- From time of Study Start up to 33 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0005
- source section id
- NCT03052608-om-0005
- source outcome index
- 5
- endpoint
- Intracranial Objective Response Rate (IC-ORR) - Percentage of Participants With Intracranial Objective Response (IC-OR) Based on BICR Assessment
- endpoint definition
- IC-ORR was the percentage of participant with intracranial objective response of complete response (CR) or partial response (PR) based on intracranial disease in the subset of participants with at least 1 intracranial lesion per RECIST version 1.1 (modified) recorded from randomization until disease progression or start of new anti-cancer therapy. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
- time origin
- From time of Study Start up to 33 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The subset of the FA population with at least 1 baseline intracranial lesion (based on BICR intracranial assessment).
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Lorlatinib
- regimen
- Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 149
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Crizotinib
- regimen
- Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 147
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Lorlatinib
- regimen
- Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 149
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Crizotinib
- regimen
- Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 147
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Lorlatinib
- regimen
- Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 149
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Crizotinib
- regimen
- Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 147
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Lorlatinib
- regimen
- Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 149
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Crizotinib
- regimen
- Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 147
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Lorlatinib
- regimen
- Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 149
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Crizotinib
- regimen
- Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 147
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Lorlatinib
- regimen
- Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Crizotinib
- regimen
- Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03052608-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-zykadia-e6f1dbd7
- nct id
- NCT03052608
- harm key
- EG000
- source section id
- NCT03052608-ae
- event group key
- EG000
- event group label
- Lorlatinib
- serious affected
- 51
- serious at risk
- 149
- other affected
- 148
- other at risk
- 149
- frequency threshold
- 5
- collection period
- From the first dose of study treatment through end of study follow-up (infinite lag) or start of new anti-cancer therapy, whichever occurred first (assessed up to 33 months).
- event definition
- The analysis of adverse events included all participants who received at least 1 dose of study drug. Participants were classified according to the treatment assigned at randomization. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different adverse events within the higher level category.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- harm key
- EG001
- source section id
- NCT03052608-ae
- event group key
- EG001
- event group label
- Crizotinib
- serious affected
- 39
- serious at risk
- 142
- other affected
- 140
- other at risk
- 142
- frequency threshold
- 5
- collection period
- From the first dose of study treatment through end of study follow-up (infinite lag) or start of new anti-cancer therapy, whichever occurred first (assessed up to 33 months).
- event definition
- The analysis of adverse events included all participants who received at least 1 dose of study drug. Participants were classified according to the treatment assigned at randomization. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different adverse events within the higher level category.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- qol key
- qol-0021
- source section id
- NCT03052608-om-0021
- source outcome index
- 21
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change From Baseline in Global Quality of Life (QOL), Functional Scales and Symptoms Scales as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) During Overall Treatment
- measure definition
- The EORTC QLQ C30 consists of 30 questions and includes 5 functional scales (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale; 3 symptom scales (fatigue, pain, nausea and vomiting); and 6 single items that assess additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial impact. All scales and single item measures range in score from 0 to 100. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms.
- time frame
- From Baseline up to Cycle 38 Day 1
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants from the FA population who completed a baseline (last patient-reported outcome (PRO) assessment prior to the first dose of study treatment) and at least 1 post-baseline PRO assessment.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- qol key
- qol-0022
- source section id
- NCT03052608-om-0022
- source outcome index
- 22
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change From Baseline in Lung Cancer Symptoms as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) During Overall Treatment
- measure definition
- The EORTC QLQ LC13 consists of 13 questions and includes 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The scale scores rang from 0 to 100, with higher scores indicating higher ("worse") level of symptoms.
- time frame
- From Baseline up to Cycle 38 Day 1
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher scores indicating higher ("worse
- population note
- Participants from the FA population who completed a baseline (last patient-reported outcome (PRO) assessment prior to the first dose of study treatment) and at least 1 post-baseline PRO assessment.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- qol key
- qol-0023
- source section id
- NCT03052608-om-0023
- source outcome index
- 23
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Visual Analogue Scale (VAS) Across Time
- measure definition
- The EuroQol EQ-5D-5L is a participant-completed questionnaire designed to assess health status. There are 2 components to the EuroQol EQ-5D-5L: a descriptive system in which individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a VAS. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) and higher scores indicate better health state.
- time frame
- Baseline, Day 1 of all cycles from Cycle 2 to Cycle 38, and End of Treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicate better
- population note
- "Number of Participants Analyzed" included all participants in the EQ-5D-5L PRO analysis population within each treatment group. "Number Analyzed" included all participants with at least a baseline and postbaseline assessment at the visit.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- qol key
- qol-0024
- source section id
- NCT03052608-om-0024
- source outcome index
- 24
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Index Across Time
- measure definition
- The EuroQol EQ-5D-5L is a participant-completed questionnaire designed to assess health status. There are 2 components to the EuroQol EQ-5D-5L: a descriptive system in which individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a VAS in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
- time frame
- Baseline, Day 1 of all cycles from Cycle 2 to Cycle 38, and End of Treatment
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- "Number of Participants Analyzed" included all participants in the PRO analysis population within each treatment group. "Number Analyzed" included all participants with at least a baseline and postbaseline assessment at the visit.
- 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-zykadia-e6f1dbd7
- nct id
- NCT03052608
- qol key
- qol-0025
- source section id
- NCT03052608-om-0025
- source outcome index
- 25
- instrument
- EORTC QLQ
- instrument basis
- matched 'qlq' in the study's own wording
- scale title
- Time to Deterioration (TTD) in Participant Reported Pain in Chest, Dyspnea, or Cough From QLQ-LC13
- measure definition
- The EORTC QLQ LC13 consists of 13 questions and includes 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The scale scores rang from 0 to 100, with higher scores indicating higher ("worse") level of symptoms. TTD in pain in chest, dyspnea, or cough was defined as the time from randomization to the first time the participant's score showed a 10 point or greater increase after baseline in any of the 3 symptoms. TTD in months was calculated as (date of deterioration or censoring - randomization date +1)/30.4375.
- time frame
- From Baseline up to 33 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher scores indicating higher ("worse
- population note
- Participants in the EORTC QLQ-LC13 PRO analysis population with change from baseline scores within each treatment group and subscale.
- 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