Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer
NCT03054038 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2022-04-14
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.
Conditions
- Non-Small Cell Lung Carcinoma
Interventions
- DRUG
-
Afatinib
Given by mouth
- BIOLOGICAL
-
Necitumumab
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
National Comprehensive Cancer Network
collaborator NETWORK -
Vanderbilt-Ingram Cancer Center
lead OTHER
Principal Investigators
-
Sally York, M.D. · Vanderbilt-Ingram Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-20
- Primary Completion
- 2022-03-23
- Completion
- 2022-03-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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