Study on Crizotinib for Patients with Stage IB-IIIA Non-small Cell Lung Cancer Removed by Surgery and ALK Fusion Mutations

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02201992

Provider View

This clinical trial is testing how well the drug crizotinib works in patients with stage IB-IIIA non-small cell lung cancer that has been surgically removed and has a specific ALK fusion mutation. The study aims to see if crizotinib can help stop the growth of cancer cells by blocking the ALK protein.

Patient Parameters

Program Overview

This study is investigating whether crizotinib, a medication that targets a specific protein mutation called ALK, can improve survival in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) that has been surgically removed. The ALK mutation can make cancer cells grow, and crizotinib may help stop this process. The trial will compare patients taking crizotinib to those under observation to see if the drug improves outcomes.

Description

The main goal of this study is to see if taking crizotinib after surgery can help patients with stage IB (tumors 4 cm or larger), II, or IIIA ALK-positive non-small cell lung cancer live longer. The study will also look at how long patients remain free of cancer and the safety of crizotinib when used after surgery. Researchers will collect tumor and blood samples for future research.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients will take crizotinib by mouth twice a day for 21-day cycles, continuing for up to 2 years unless the cancer progresses or side effects become unacceptable.
  • Group B: Patients will be observed without taking crizotinib.

After finishing the study treatment, patients will have follow-up visits every 6 months for up to 4 or 5 years, and then annually for up to 10 years.

Eligibility Criteria

Inclusion Criteria

  • Must have had complete surgical removal of stage IB (tumors 4 cm or larger), II, or IIIA non-small cell lung cancer with no cancer left at the edges of the removed tissue.
  • Must have a chest CT scan within 6 months before joining the study to confirm no remaining cancer.
  • Must have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must be registered in the ALCHEMIST-SCREEN trial before joining this study.
  • Must have a positive test for ALK gene changes, confirmed by a certified lab.
  • Women must not be pregnant or breastfeeding and must have a negative pregnancy test before joining.
  • Must agree to use effective birth control during the study.
  • Must not have serious ongoing illnesses that could interfere with the study.
  • Must not have lung diseases like interstitial fibrosis.
  • Must not have taken crizotinib or similar drugs before.
  • Must not have serious heart rhythm problems or be taking certain medications that affect liver enzymes.
  • Must be recovered from surgery and any previous treatments before joining.
  • Must meet specific blood test requirements for liver and kidney function, blood cell counts, and other health indicators.
  • Must not have had other cancers requiring treatment in the past 5 years, except for certain skin cancers or in-situ carcinomas.
  • Must not be participating in other clinical trials while on this study.

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