OncRef

Clinical Trial: NCT03456076

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2026-10-14

Study Overview

Brief Summary

This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months.

Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

Official Title

A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention / Treatment

  • Drug: Alectnib
  • Drug: Cisplatin
  • Drug: Vinorelbine
  • Drug: Gemcitabine
  • Drug: Pemetrexed
  • Drug: Carboplatin

Other Study ID Numbers

  • BO40336
  • 2017-004331-37
  • 2017

Start Date (Actual)

2018-08-16

Primary Completion Date (Actual)

2023-06-26

Study Completion Date (Estimated)

2031-11-19

Enrollment (Actual)

257

Study Type

Interventional

Phase

Phase 3