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

Investigating the Effectiveness of an Investigational Medication in ALK-Positive Lung Cancer

Recruiting
18 years and older
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study investigates the effectiveness of an investigational medication compared to a placebo in treating patients with stage IB-IIIA non-small cell lung cancer (NSCLC) that has been surgically removed and has a mutation in the anaplastic lymphoma kinase (ALK) gene. ALK is a protein that, when altered, can contribute to the growth of cancer cells. The purpose of this study is to determine if the investigational medication can improve overall survival in patients with ALK-positive NSCLC after surgery.

Participants in the study will be randomly assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. This study will involve regular monitoring and assessments to evaluate the health and progress of the participants.

  • Who can participate: Adults who have had complete surgical removal of stage IB (tumor size 4 cm or larger), II, or IIIA non-squamous NSCLC with negative margins are eligible. Participants must have a positive ALK gene mutation and meet specific health criteria, including a good performance status and no uncontrolled illnesses. Participants must also be registered to the ALCHEMIST-SCREEN trial and must not have received prior treatment with crizotinib.
  • Study details: Participants must follow the study guidelines and attend all scheduled visits.
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Study details
    Anaplastic Lymphoma Kinase
    ALK
    non-small cell lung cancer
    non small cell lung cancer
    non-small cell
    non small cell
    lung cancer
    cancer
    lung
    lungs
    oncology

TX7271

19 February 2024

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