Afatinib +/− Cetuximab for Non-Small Cell Lung Cancer

Recruiting at 637 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: SWOG Cancer Research Network

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in treating patients with non-small cell lung cancer.

Research Team

Sarah Goldberg

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with stage IV or recurrent non-small cell lung cancer (NSCLC) that tests positive for EGFR mutations. Participants must be able to take oral medication, have not had major surgery recently, and cannot have active hepatitis B/C or HIV. They should not have significant heart issues, gastrointestinal disorders causing diarrhea, or a history of allergic reactions to similar drugs. Women who are pregnant or nursing are excluded.

Inclusion Criteria

My cancer has specific EGFR mutations and was tested in a certified lab.

Prestudy history and physical must be obtained with 28 days prior to registration

I've had a brain scan in the last 42 days showing no symptoms of brain cancer.

Treatment Details

Interventions

• Afatinib Dimaleate (Tyrosine Kinase Inhibitor)
• Cetuximab (Monoclonal Antibodies)

Trial Overview The study compares the effectiveness of afatinib dimaleate alone versus combined with cetuximab in treating NSCLC with EGFR mutations. Afatinib blocks enzymes needed for tumor growth while cetuximab targets certain cells to inhibit tumor expansion.

Participant Groups

Group I: Arm I (afatinib dimaleate, cetuximab) Experimental Treatment 3 Interventions

Patients receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (afatinib dimaleate) Active Control 2 Interventions

Patients receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+