Study on Osimertinib With or Without Bevacizumab for Initial Treatment of EGFR-Mutant Lung Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04181060

Provider View

This clinical trial is comparing two treatments for non-small cell lung cancer with an EGFR mutation: osimertinib alone or in combination with bevacizumab. The study aims to see if adding bevacizumab can help control cancer better and improve patient survival.

Patient Parameters

Program Overview

This study is testing whether combining the drug osimertinib with bevacizumab is more effective than using osimertinib alone for treating non-small cell lung cancer that has spread beyond the lungs and has a specific EGFR mutation. Osimertinib works by blocking signals that help cancer cells grow, while bevacizumab may help stop cancer cells from growing and spreading. The study will help determine if the combination treatment can control cancer for a longer time and help patients live longer.

Description

The main goal of this study is to see if the combination of osimertinib and bevacizumab can help patients live longer without their cancer getting worse, compared to osimertinib alone. Researchers will also look at overall survival, how well the cancer responds to treatment, and any side effects from the combination treatment.

Participants will be randomly assigned to one of two groups. One group will take osimertinib daily, while the other group will take osimertinib daily and receive bevacizumab through an IV every three weeks. Both groups will continue treatment as long as it is effective and side effects are manageable.

Throughout the study, participants will have regular check-ups, including heart and imaging tests, and blood samples will be collected. After finishing the study treatment, participants will be followed up every three months for up to 10 years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of non-small cell lung cancer that is not squamous type.
  • Cancer must be advanced, either stage IV, stage IIIB not treatable with surgery, or has returned after previous treatment.
  • Must have a specific EGFR mutation that makes the cancer sensitive to treatment.
  • Must not have received any previous treatment with anti-VEGF drugs.
  • Must not have had any prior treatment for metastatic disease.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Must not be pregnant or breastfeeding, and must agree to use effective contraception during and after treatment.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Must not have any serious heart conditions or risk factors for heart problems.
  • Must not have any unresolved side effects from previous treatments, except for hair loss or mild nerve damage.
  • Must not have any serious or uncontrolled medical conditions that could interfere with the study.
  • Must not have any history of lung diseases that required steroid treatment.
  • Must not have any allergies to the study drugs or similar medications.
  • Must not have any conditions that could increase the risk of heart rhythm problems.

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