Trial · NCT02075840
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
NCT02075840, Phase 3, Completed, Hoffmann-La Roche; results first posted 2018-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants. Trials, record NCT02075840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02075840
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
- NCT number
- NCT02075840
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 303 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Alectinib, Crizotinib
- First posted
- 2014-03-03
- Last updated
- 2026-05-29
- Other registries' IDs
- eudract:2013-004133-33
- Results first posted
- 2018-03-15
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) by Investigator Assessment | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions. |
| Primary | Percentage of Participants With PFS Event by Investigator Assessment | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions. |
| Secondary | PFS Independent Review Committee (IRC)-Assessed | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. |
| Secondary | Percentage of Participants With PFS Event by IRC | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. |
| Secondary | Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria | Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months) | CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib. |
| Secondary | Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria | Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months) | CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib. |
| Secondary | Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators | First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to approximately 10 years) | DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR. |
| Secondary | Overall Survival (OS) | From randomization until death (up to 10.5 years) | Overall survival (OS) was defined as the time from randomization to death from any cause. |
| Secondary | Percentage of Participants With OS Event | From randomization until death (up to 10.5 years) | Overall survival (OS) was defined as the time from randomization to death from any cause. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
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) by Investigator Assessment | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | months | MEDIAN |
| PRIMARY | Percentage of Participants With PFS Event by Investigator Assessment | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | PFS Independent Review Committee (IRC)-Assessed | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Percentage of Participants With PFS Event by IRC | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria | Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria | Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators | First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization until death (up to 43 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Percentage of Participants With OS Event | From randomization until death (up to 43 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group374
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) by Investigator Assessment | Alectinib | NA | 95% Confidence Interval 17.7 to NA | months | |
| Progression-Free Survival (PFS) by Investigator Assessment | Crizotinib | 11.1 | 95% Confidence Interval 9.1 to 13.1 | months | |
| Percentage of Participants With PFS Event by Investigator Assessment | Alectinib | 40.8 | Percentage of Participants | ||
| Percentage of Participants With PFS Event by Investigator Assessment | Crizotinib | 67.5 | Percentage of Participants | ||
| PFS Independent Review Committee (IRC)-Assessed | Alectinib | 25.7 | 95% Confidence Interval 19.9 to NA | months | |
| PFS Independent Review Committee (IRC)-Assessed | Crizotinib | 10.4 | 95% Confidence Interval 7.7 to 14.6 | months | |
| Percentage of Participants With PFS Event by IRC | Alectinib | 41.4 | Percentage of Participants | ||
| Percentage of Participants With PFS Event by IRC | Crizotinib | 60.9 | Percentage of Participants | ||
| Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria | Alectinib | 11.8 | Percentage of Participants | ||
| Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria | Crizotinib | 45.0 | Percentage of Participants |
1 to 10 of 374Source ClinicalTrials.gov
See all 374 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alectinib | 152 | |
| Overall Study | STARTED | Crizotinib | 151 | |
| Overall Study | COMPLETED | Alectinib | 0 | |
| Overall Study | COMPLETED | Crizotinib | 0 | |
| Overall Study | NOT COMPLETED | Alectinib | 152 | |
| Overall Study | NOT COMPLETED | Crizotinib | 151 |
Source ClinicalTrials.gov
Adverse events266
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 | Constipation | Gastrointestinal disorders | Alectinib | 52 | 152 | |
| other | Constipation | Gastrointestinal disorders | Crizotinib | 49 | 151 | |
| other | Nausea | Gastrointestinal disorders | Alectinib | 21 | 152 | |
| other | Nausea | Gastrointestinal disorders | Crizotinib | 70 | 151 | |
| other | Diarrohea | Gastrointestinal disorders | Alectinib | 18 | 152 | |
| other | Diarrohea | Gastrointestinal disorders | Crizotinib | 68 | 151 | |
| other | Vomiting | Gastrointestinal disorders | Alectinib | 11 | 152 | |
| other | Vomiting | Gastrointestinal disorders | Crizotinib | 57 | 151 | |
| other | Abdominal Pain | Gastrointestinal disorders | Alectinib | 9 | 152 | |
| other | Abdominal Pain | Gastrointestinal disorders | Crizotinib | 7 | 151 |
1 to 10 of 266Source ClinicalTrials.gov
See all 266 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alectinib | 35 | 152 |
| Total, all-cause mortality | Crizotinib | 40 | 151 |
| Total, other adverse events | Alectinib | 136 | 152 |
| Total, other adverse events | Crizotinib | 140 | 151 |
| Total, serious adverse events | Alectinib | 44 | 152 |
| Total, serious adverse events | Crizotinib | 45 | 151 |
Source ClinicalTrials.gov
Papers7
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Alectinib vs Crizotinib: deaths from any cause | Trial comparisons |
| Alectinib vs Crizotinib: serious adverse events | Trial comparisons |
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02075840
GET https://conductscience.org/api/trials/v1/NCT02075840/registered?page=2