Trial · NCT02737501
ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
NCT02737501, Phase 3, Completed, Ariad Pharmaceuticals; results first posted 2021-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants. Trials, record NCT02737501. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02737501
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
- NCT number
- NCT02737501
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 275 participants, actual
- Lead sponsor
- Ariad Pharmaceuticals
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer, Advanced Malignancies, Carcinoma
- Interventions
- Brigatinib, Crizotinib
- First posted
- 2016-04-14
- Last updated
- 2021-08-20
- Other registries' IDs
- eudract:2015-003447-19
- Results first posted
- 2021-08-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to end of study (Up to 56 months) | PFS as assessed by Blinded Independent Review Committee (BIRC), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, was defined as the time interval from the date of randomization until the date of the first documented PD event. The data was censored for participants without a PFS event. |
| Secondary | Confirmed Objective Response Rate (ORR) | Baseline up to end of treatment (Up to 36 months) | ORR was defined as percentage of participants who achieved Complete response (CR) or Partial responses (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1 criteria. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to less than (\<) 10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in SLD of target lesions, taking as reference baseline sum diameters. |
| Secondary | Confirmed Intracranial ORR (iORR) | Baseline up to end of treatment (Up to 36 months) | ORR was defined as percentage of participants who achieved CR or PR in the central nervous system (CNS) in randomized participants with intracranial CNS metastasis at baseline. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Intracranial Progression Free Survival | Baseline up to end of study (Up to 56 months) | Intracranial PFS as assessed by BIRC, is defined as the time from randomization until first CNS PD is documented, or death due to any cause. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and unequivocal progression of existing non-target lesions. |
| Secondary | Overall Survival (OS) | Baseline up to end of study (Up to 56 months) | Overall survival is defined as the time from randomization until death due to any cause. |
| Secondary | Duration of Response (DOR) | Baseline up to end of study (Up to 56 months) | Duration of response as assessed by BIRC, is defined as the time interval from the date that the criteria are first met for CR/PR (whichever is first recorded) until the first date that progressive disease (PD) is objectively documented. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30 % decrease in the SLD of target lesions, taking as reference the baseline sum diameters. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and for non-target lesions, unequivocal progression of existing non-target lesions. |
| Secondary | Time to Response (TTR) | Baseline up to end of treatment (Up to 36 months) | Time to response as assessed by BIRC, assessment and is defined as the time interval from the date of randomization until the initial observation of CR or PR. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Disease Control Rate (DCR) | Baseline up to end of treatment (Up to 36 months) | Disease control as assessed by BIRC, defined as percentage of randomized participants who have achieved CR, PR, or stable disease (SD) after randomization. CR defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR: at least a 30% decrease in SLD of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: SLD increased by at least 20% from the smallest value on study, SLD must also demonstrate an absolute increase of at least 5 mm, and unequivocal progression of existing non-target lesions. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose up to 30 days after last dose of study drug (Up to approximately 37 months) | An AE is any untoward medical occurrence in a participant. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug (i.e., occurs after the first dose of study drug) is also an AE. TEAEs are defined as AEs starting/worsening on or after the first dose of study treatment and no later than the earliest of 30 days after the last dose of the treatment to which the participant was assigned, or the day before start of brigatinib therapy in crossover participant. |
| Secondary | Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 (Version 3.0) | Baseline and Month 36 | HRQoL: perceived quality of participant's life, includes self-reported multidimensional measures of physical and mental health. Patient-reported symptoms (PROs) and HRQoL will be collected by administering the european organisation for research and treatment of cancer (EORTC) quality of life (QLQ)-C30 questionnaire. EORTC-QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. The 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into overall score ranging from 0 to 100, where lower scores indicate better QOL. A negative change from Baseline indicates improvement. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Up to end of study (Up to 56 months) | ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. | months | MEDIAN |
| SECONDARY | Confirmed Objective Response Rate (ORR) | Baseline up to end of treatment (Up to 36 months) | ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. | percentage of participants | NUMBER |
| SECONDARY | Confirmed Intracranial ORR (iORR) | Baseline up to end of treatment (Up to 36 months) | ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses. | percentage of participants | NUMBER |
| SECONDARY | Intracranial Progression Free Survival | Baseline up to end of study (Up to 56 months) | ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline up to end of study (Up to 56 months) | ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Baseline up to end of study (Up to 56 months) | ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Only responders were reported for this outcome measure. | months | MEDIAN |
| SECONDARY | Time to Response (TTR) | Baseline up to end of treatment (Up to 36 months) | ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Only responders were reported for this outcome measure. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Baseline up to end of treatment (Up to 36 months) | ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose up to 30 days after last dose of study drug (Up to approximately 37 months) | Treated Population included all participant who received at least 1 dose of study drug and served as basis of safety analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 (Version 3.0) | Baseline and Month 36 | ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Randomized Phase: Brigatinib 90 mg QD/180 QD | 24.016 | 95% Confidence Interval 18.46 to 43.20 | months | |
| Progression-free Survival (PFS) | Randomized Phase: Crizotinib 250 mg BID | 11.072 | 95% Confidence Interval 9.13 to 13.01 | months | |
| Progression-free Survival (PFS) | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 16.821 | 95% Confidence Interval 10.12 to 23.85 | months | |
| Confirmed Objective Response Rate (ORR) | Randomized Phase: Brigatinib 90 mg QD/180 QD | 74.5 | 95% Confidence Interval 66.30 to 81.52 | percentage of participants | |
| Confirmed Objective Response Rate (ORR) | Randomized Phase: Crizotinib 250 mg BID | 62.3 | 95% Confidence Interval 53.68 to 70.42 | percentage of participants | |
| Confirmed Objective Response Rate (ORR) | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 56.9 | 95% Confidence Interval 44.04 to 69.15 | percentage of participants | |
| Confirmed Intracranial ORR (iORR) | Randomized Phase: Brigatinib 90 mg QD/180 QD | 66.0 | 95% Confidence Interval 50.69 to 79.14 | percentage of participants | |
| Confirmed Intracranial ORR (iORR) | Randomized Phase: Crizotinib 250 mg BID | 14.3 | 95% Confidence Interval 5.94 to 27.24 | percentage of participants | |
| Confirmed Intracranial ORR (iORR) | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 35.7 | 95% Confidence Interval 21.55 to 51.97 | percentage of participants | |
| Intracranial Progression Free Survival | Randomized Phase: Brigatinib 90 mg QD/180 QD | 23.951 | 95% Confidence Interval 12.91 to 30.78 | months |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Phase | STARTED | Randomized Phase: Brigatinib 90 mg QD/180 QD | 137 | |
| Randomized Phase | STARTED | Randomized Phase: Crizotinib 250 mg BID | 138 | |
| Randomized Phase | STARTED | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 0 | |
| Randomized Phase | Safety Analysis Set | Randomized Phase: Brigatinib 90 mg QD/180 QD | 136 | |
| Randomized Phase | Safety Analysis Set | Randomized Phase: Crizotinib 250 mg BID | 137 | |
| Randomized Phase | Safety Analysis Set | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 0 | |
| Randomized Phase | COMPLETED | Randomized Phase: Brigatinib 90 mg QD/180 QD | 20 | |
| Randomized Phase | COMPLETED | Randomized Phase: Crizotinib 250 mg BID | 84 | |
| Randomized Phase | COMPLETED | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 0 | |
| Randomized Phase | NOT COMPLETED | Randomized Phase: Brigatinib 90 mg QD/180 QD | 117 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events693
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper Respiratory Tract Infection | Infections and infestations | Randomized Phase: Brigatinib 90 mg QD/180 QD | 18 | 136 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Randomized Phase: Crizotinib 250 mg BID | 12 | 137 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 6 | 65 | |
| other | Nasopharyngitis | Infections and infestations | Randomized Phase: Brigatinib 90 mg QD/180 QD | 12 | 136 | |
| other | Nasopharyngitis | Infections and infestations | Randomized Phase: Crizotinib 250 mg BID | 15 | 137 | |
| other | Nasopharyngitis | Infections and infestations | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 5 | 65 | |
| other | Urinary Tract Infection | Infections and infestations | Randomized Phase: Brigatinib 90 mg QD/180 QD | 10 | 136 | |
| other | Urinary Tract Infection | Infections and infestations | Randomized Phase: Crizotinib 250 mg BID | 11 | 137 | |
| other | Urinary Tract Infection | Infections and infestations | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 5 | 65 | |
| other | Pneumonia | Infections and infestations | Randomized Phase: Brigatinib 90 mg QD/180 QD | 10 | 136 |
1 to 10 of 693Source ClinicalTrials.gov
See all 693 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomized Phase: Brigatinib 90 mg QD/180 QD | 41 | 137 |
| Total, all-cause mortality | Randomized Phase: Crizotinib 250 mg BID | 29 | 138 |
| Total, all-cause mortality | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 22 | 65 |
| Total, other adverse events | Randomized Phase: Brigatinib 90 mg QD/180 QD | 132 | 136 |
| Total, other adverse events | Randomized Phase: Crizotinib 250 mg BID | 135 | 137 |
| Total, other adverse events | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 63 | 65 |
| Total, serious adverse events | Randomized Phase: Brigatinib 90 mg QD/180 QD | 56 | 136 |
| Total, serious adverse events | Randomized Phase: Crizotinib 250 mg BID | 53 | 137 |
| Total, serious adverse events | Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 24 | 65 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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