NCT03054038

Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer

Phase I Trial of Combination Afatinib and Necitumumab in EGFR Mutation Positive NSCLC With Acquired Resistance to First or Third Generation EGFR TKIs

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of afatinib and necitumumab and to see how well they work in treating patients with EGFR mutation positive non-small cell lung cancer that has spread to other places in the body. Afatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as necitumumab, may interfere with the ability of tumor cells to grow and spread. Giving afatinib and necitumumab may work better in treating patients with EGFR mutation positive non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of combination afatinib and necitumumab therapy in EGFR mutation positive non-small cell lung cancer (NSCLC) patients who have progressed following first- and third-generation EGFR tyrosine kinase inhibitors (TKIs). II. To determine the efficacy and safety profile of afatinib and necitumumab combination therapy in patients with EGFR mutation positive NSCLC patients who have progressed following first- and third-generation EGFR TKIs. OUTLINE: This is a dose-escalation study. Patients receive afatinib orally (PO) once daily (QD) on days 1-28 and necitumumab intravenously (IV) over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28 days and then every 3 months for up to 1 year.

Conditions

• Non-Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Afatinib	Given by mouth
BIOLOGICAL	Necitumumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-07-20
• Primary completion: 2022-03-23
• Completion: 2022-03-23
• First posted: 2017-02-15
• Last updated: 2022-04-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study