Trial · NCT02838420
A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT02838420, Phase 3, Completed, Hoffmann-La Roche; results first posted 2019-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT02838420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02838420
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT02838420
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 187 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer
- Interventions
- Alectinib, Crizotinib
- First posted
- 2016-07-20
- Last updated
- 2026-06-24
- Results first posted
- 2019-07-11
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 | From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 40 months) | PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by the investigators, or to death from any cause, whichever occurred first. |
| Secondary | PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by an independent review committee, or to death from any cause, whichever occurred first. |
| Secondary | Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Time to Progression of Disease in the CNS as Determined by IRC Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Time to Progression of Disease in the CNS as Determined by IRC Using Response Assessment in Neuro-Oncology (RANO) | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Duration of Response (DOR) Assessed by Investigator Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Overall Survival Time | Baseline, until death (up to overall period of approximately 40 months) | |
| Secondary | Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events | Up to overall period of approximately 40 months | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
| Secondary | Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Core (QLQ-C30) Score | Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer Module (QLQ-LC13) Score | Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 | From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 40 months) | The primary analysis population for efficacy was the intent-to-treat (ITT) population, defined as all randomized participants. | Months | MEDIAN |
| SECONDARY | PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Time to Progression of Disease in the CNS as Determined by IRC Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Time to Progression of Disease in the CNS as Determined by IRC Using Response Assessment in Neuro-Oncology (RANO) | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Duration of Response (DOR) Assessed by Investigator Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Overall Survival Time | Baseline, until death (up to overall period of approximately 40 months) | |||
| SECONDARY | Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events | Up to overall period of approximately 40 months | The safety population was defined as all participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Core (QLQ-C30) Score | Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer Module (QLQ-LC13) Score | Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group18
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) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 | Alectinib | NA | 95% Confidence Interval 20.3 to NA | Months | |
| Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 | Crizotinib | 11.1 | 95% Confidence Interval 9.1 to 13.0 | Months | |
| Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events | Alectinib | Serious Adverse Events | 15.2 | Percentage of Participants | |
| Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events | Crizotinib | Serious Adverse Events | 25.8 | Percentage of Participants | |
| Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events | Alectinib | Non-Serious Adverse Events | 99.2 | Percentage of Participants | |
| Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events | Crizotinib | Non-Serious Adverse Events | 100.0 | Percentage of Participants | |
| Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite | Alectinib | Alectinib Baseline | 1590 | Standard Deviation 852 | Hours*nanogram/milliliter (hr*ng/mL) |
| Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite | Alectinib | M4 Baseline | 471 | Standard Deviation 243 | Hours*nanogram/milliliter (hr*ng/mL) |
| Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite | Alectinib | Alectinib Week 4 | 7760 | Standard Deviation 3270 | Hours*nanogram/milliliter (hr*ng/mL) |
| Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite | Alectinib | M4 Week 4 | 2890 | Standard Deviation 1130 | Hours*nanogram/milliliter (hr*ng/mL) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 | 125 | |
| Overall Study | STARTED | Crizotinib | 62 | |
| Overall Study | COMPLETED | Alectinib | 0 | |
| Overall Study | COMPLETED | Crizotinib | 0 | |
| Overall Study | NOT COMPLETED | Alectinib | 125 | |
| Overall Study | NOT COMPLETED | Crizotinib | 62 |
Source ClinicalTrials.gov
Adverse events198
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 | Aspartate aminotransferase increased | Investigations | Alectinib | 65 | 125 | |
| other | Aspartate aminotransferase increased | Investigations | Crizotinib | 31 | 62 | |
| other | Alanine aminotransferase increased | Investigations | Alectinib | 52 | 125 | |
| other | Alanine aminotransferase increased | Investigations | Crizotinib | 34 | 62 | |
| other | Blood creatine phosphokinase increased | Investigations | Alectinib | 55 | 125 | |
| other | Blood creatine phosphokinase increased | Investigations | Crizotinib | 18 | 62 | |
| other | Blood bilirubin increased | Investigations | Alectinib | 61 | 125 | |
| other | Blood bilirubin increased | Investigations | Crizotinib | 2 | 62 | |
| other | Blood alkaline phosphatase increased | Investigations | Alectinib | 33 | 125 | |
| other | Blood alkaline phosphatase increased | Investigations | Crizotinib | 8 | 62 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alectinib | 8 | 125 |
| Total, all-cause mortality | Crizotinib | 13 | 62 |
| Total, other adverse events | Alectinib | 124 | 125 |
| Total, other adverse events | Crizotinib | 62 | 62 |
| Total, serious adverse events | Alectinib | 19 | 125 |
| Total, serious adverse events | Crizotinib | 16 | 62 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30981696 | DERIVED |
Source PubMed
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/NCT02838420
GET https://conductscience.org/api/trials/v1/NCT02838420/events?page=2