Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT05045404
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT05045404
Study Brief:
Protocol Section:
NCT05045404