Study on Afatinib Dimaleate With or Without Cetuximab for Treating Stage IV or Recurrent EGFR Mutation Positive Non-small Cell Lung Cancer

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02438722

Provider View

This clinical trial is testing whether the combination of afatinib dimaleate and cetuximab is more effective than afatinib dimaleate alone in treating patients with advanced or returning non-small cell lung cancer that has a specific genetic mutation.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of afatinib dimaleate alone versus in combination with cetuximab in treating patients with advanced or recurrent non-small cell lung cancer that has a specific mutation in the EGFR gene. Afatinib dimaleate works by blocking certain enzymes needed for cancer cell growth, while cetuximab is a monoclonal antibody that targets cancer cells in different ways. The study aims to determine which treatment is more effective in controlling the cancer.

Description

This study is divided into two phases: Phase II and Phase III.

In Phase II, researchers will evaluate if there is enough evidence to continue to Phase III by comparing how long patients live without their cancer getting worse when treated with afatinib and cetuximab versus afatinib alone.

In Phase III, the study will determine if the combination of afatinib and cetuximab improves overall survival compared to afatinib alone.

Secondary goals include assessing the response rate to the treatments, the safety of each treatment, and the time until treatment failure or discontinuation.

The study will also explore the molecular mechanisms that may influence the benefits of the treatments, including the presence of specific mutations and resistance mechanisms.

Participants will be randomly assigned to one of two groups:

  • Group 1: Receive afatinib dimaleate daily and cetuximab every two weeks.
  • Group 2: Receive afatinib dimaleate daily.

Both groups will continue treatment in 28-day cycles as long as the cancer does not progress and side effects are manageable.

After completing the study treatment, participants will be followed up for three years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC).
  • Have a specific EGFR mutation (exon 19 deletion or exon 21 L858R substitution) confirmed by an approved test.
  • Agree to provide tissue and blood samples for research purposes.
  • Have not received prior systemic treatment for advanced or metastatic NSCLC.
  • Have measurable or non-measurable disease as confirmed by CT or MRI scans.
  • Have a CT or MRI scan of the brain showing no symptomatic brain metastases.
  • Meet specific blood count and organ function criteria.
  • Be able to swallow oral medication.
  • Not have significant gastrointestinal disorders with diarrhea as a major symptom.
  • Not have a history of significant heart problems or recent major surgery.
  • Not have active hepatitis B, hepatitis C, or HIV infection.
  • Not have any other serious illness that could interfere with the study.
  • Not be pregnant or nursing and agree to use effective contraception if of reproductive potential.
  • Be informed about the study and provide written consent to participate.

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