OncRef

Clinical Trial: NCT02201992

Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:ECOG-ACRIN Cancer Research Group
Information Provided By:Eastern Cooperative Oncology Group
Last Update Posted:2025-12-19

Study Overview

Brief Summary

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

Official Title

A Randomized Phase III Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Observation for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Conditions

ALK Gene Rearrangement, ALK Gene Translocation, ALK Positive, Stage IB Non-Small Cell Lung Carcinoma AJCC v7, Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7

Intervention / Treatment

  • Other: Clinical Observation
  • Drug: Crizotinib
  • Other: Laboratory Biomarker Analysis

Other Study ID Numbers

  • E4512
  • NCI-2014-01507
  • s16-02072
  • E4512
  • E4512
  • U10CA180820
  • U10CA180830
  • U10CA021115
  • U24CA196172

Start Date (Actual)

2015-03-23

Primary Completion Date (Estimated)

2036-05-01

Study Completion Date (Estimated)

2036-05-01

Enrollment (Actual)

166

Study Type

Interventional

Phase

Phase 3