NCT03066206

Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC

A Phase II Study of Poziotinib in EGFR or HER2 Mutant Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well poziotinib works in treating patients with non-small lung cancer with an EGFR or HER2 exon 20 mutation that is stage IV or has come back (recurrent). Poziotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth..

Detailed description

PRIMARY OBJECTIVES: I. To assess the objective response rate (ORR) to poziotinib according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in non-small cell lung cancer (NSCLC) with EGFR exon 20 mutations. II. Assess the objective response rate (ORR) to poziotinib according to RECIST 1.1 criteria in NSCLC with HER2 (ErBB2) exon 20 mutations. III. Assess the objective response rate (ORR) to poziotinib according to RECIST 1.1 criteria in advanced solid tumors with EGFR exon 20 or HER2 exon 20 mutations. IV. Assess the objective response rate (ORR) to poziotinib according to RECIST 1.1 criteria in advanced solid tumors with HER2 exon 19 mutations ORR will be calculated as the percent of patients whose best confirmed response is complete response (CR, defined as disappearance of all target lesions) or partial response (PR, defined as at least a 30% decrease in the sum of longest diameter \[LD\] of target lesions, taking as reference the baseline sum LD). SECONDARY OBJECTIVES: I. Disease control rate (complete response + partial response + stable response) of poziotinb in cohort 1 and 2, analyzed independently. II. Progression free survival of poziotinb in cohort 1 and 2, analyzed independently. III. Overall survival of poziotinb in cohort 1 and 2, analyzed independently. IV. Duration of response of poziotinb in cohort 1 and 2, analyzed independently. V. Safety and toxicity. EXPLORATORY OBJECTIVES: I. To assess molecular markers associated with resistance and response to poziotinib, including secondary mutations. OUTLINE: Patients receive poziotinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.

Conditions

• EGFR Exon 20 Mutation
• ERBB2 Gene Mutation
• Recurrent Lung Non-Small Cell Carcinoma
• Stage IV Non-Small Cell Lung Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Poziotinib	Given PO

Timeline

• Start date: 2017-03-17
• Primary completion: 2026-02-16
• Completion: 2026-02-16
• First posted: 2017-02-28
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study