OncRef

Clinical Trial: NCT02075840

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2026-05-29

Study Overview

Brief 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.

Official Title

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

Conditions

Non-Small Cell Lung Cancer

Intervention / Treatment

  • Drug: Alectinib
  • Drug: Crizotinib

Other Study ID Numbers

  • BO28984
  • 2013-004133-33

Start Date (Actual)

2014-08-19

Primary Completion Date (Actual)

2017-02-09

Study Completion Date (Actual)

2025-04-28

Enrollment (Actual)

303

Study Type

Interventional

Phase

Phase 3