Stage IV Lung Cancer AJCC v8 Clinical Trial
Official title:
A Phase II Study of Poziotinib and Ramucirumab in EGFR Exon 20 Mutant Advanced Non-small Cell Lung Cancer (NSCLC)
This phase II trial tests whether poziotinib and ramucirumab work to shrink tumors in patients with EGFR Exon 20 gene mutant stage IV non-small cell lung cancer. Poziotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ramucirumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving poziotinib and ramucirumab may help to control the disease.
PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of poziotinib and ramucirumab as measured by progression free survival. SECONDARY OBJECTIVES: I. To estimate the objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for the combination of poziotinib and ramucirumab. II. To estimate the disease control rate (complete response + partial response + stable disease), overall survival, and duration of response of the study combination. III. To assess the safety and the toxicity of the study combination. EXPLORATORY OBJECTIVE: I. To assess molecular markers associated with resistance and response to poziotinib and ramucirumab. OUTLINE: Patients receive poziotinib hydrochloride orally (PO) twice daily (BID) on day 1 and ramucirumab intravenously (IV) over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days, then every 6 months thereafter. ;
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