Study on 5 Years of Osimertinib Treatment After Surgery for Non-Small Cell Lung Cancer with EGFR Mutation

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05526755

Provider View

This clinical trial is evaluating the effectiveness and safety of taking osimertinib for five years after surgery in patients with non-small cell lung cancer (NSCLC) that has specific EGFR mutations. The study includes patients who have had their tumors completely removed, with or without additional chemotherapy.

Patient Parameters

Program Overview

The purpose of this study is to determine if taking osimertinib for five years after surgery can help control non-small cell lung cancer (NSCLC) in patients with specific EGFR mutations. The study focuses on patients whose cancer has been completely removed through surgery and who may or may not have received additional chemotherapy. Researchers aim to assess how well this treatment works and its safety for patients with stage II to IIIB NSCLC.

Description

This study is a phase 2 trial that is open to patients with stage II to IIIB non-small cell lung cancer (NSCLC) who have specific mutations in the EGFR gene. The trial will evaluate the effectiveness and safety of taking osimertinib for five years after surgery to remove the cancer. Participants must have had their tumors completely removed and may have received additional chemotherapy. The study aims to see if this long-term treatment can help prevent the cancer from returning.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) with specific non-squamous cell types.
  • Have had a brain scan using MRI or CT.
  • Cancer must be classified as stage II, IIIA, or IIIB after surgery.
  • Tumor must have specific EGFR mutations confirmed by a local lab.
  • Must have had complete surgical removal of the cancer with no remaining disease.
  • Must have fully recovered from surgery and any standard post-operative treatments.
  • Must have a performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting treatment.
  • Men must use effective barrier contraception.

Exclusion Criteria

  • Have had major surgery within four weeks before starting the study drug.
  • Currently taking medications or supplements that strongly affect liver enzymes (CYP3A4).
  • Have had only limited lung surgeries like segmentectomies or wedge resections.
  • Have a history of other cancers, except for certain skin cancers or other cancers treated successfully over five years ago.
  • Have received certain cancer treatments, including radiation or specific chemotherapies, before or after surgery for the current lung cancer.
  • Have difficulty swallowing pills or have gastrointestinal issues that affect drug absorption.
  • Have certain heart conditions, including prolonged QT interval or a history of heart rhythm problems.
  • Have a history of lung diseases like interstitial lung disease or radiation pneumonitis.
  • Have inadequate bone marrow or organ function.
  • Women who are breastfeeding.

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