CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 303 enrolled
Drug / intervention
Alectinib +1 moredrug
Likely dose
Alectinib 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02075840
NCT02075840Phase 3Completed
CompareCT.gov

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

Hoffmann-La Roche·interventional·Posted Mar 3, 2014·Updated May 29, 2026

In Brief

A Phase 3 clinical trial evaluating Alectinib and Crizotinib for Non-Small Cell Lung Cancer. Completed, enrolled 303 participants across 97 sites in 29 countries.

Detailed Summary

This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesAustralia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Egypt, France, Guatemala, Hong Kong, Israel, Italy, Mexico, New Zealand, Poland, Portugal, Russia, Serbia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 3, 2014
Enrollment StartAug 19, 2014
Primary CompletionFeb 9, 2017
Study CompletionApr 28, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.3 years ago

Interventions

Alectinibdrug

Participants will receive alectinib 600 mg orally (four 150 mg capsules) BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Crizotinibdrug

Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.