NCT05045404

Poziotinib and Ramucirumab for the Treatment of EGFR Exon 20 Mutant Stage IV Non-small Cell Lung Cancer

A Phase II Study of Poziotinib and Ramucirumab in EGFR Exon 20 Mutant Advanced Non-small Cell Lung Cancer (NSCLC)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Poziotinib Hydrochloride	1429757-68-5, HM781-36B, NOV-1201 Hydrochloride, NOV120101 Hydrochloride, Poziotinib HCl, POZIOTINIB HYDROCHLORIDE Given PO
BIOLOGICAL	1429757-68-5, HM781-36B, NOV-1201 Hydrochloride, NOV120101 Hydrochloride, Poziotinib HCl, POZIOTINIB HYDROCHLORIDE	Biological/Vaccine Ramucirumab 947687-13-0, anti-VEGFR-2 fully human monoclonal antibody IMC-1121B, Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC-1121B, IMC-1121B, LY3009806, Monoclonal Antibody HGS-ETR2, ramucirumab, RAMUCIRUMAB Given IV

Timeline

• Start date: 2021-06-16
• Primary completion: 2023-02-02
• Completion: 2023-02-02
• First posted: 2021-09-16
• Last updated: 2023-09-13

Regulatory

• FDA-regulated drug study