NCT04044170

Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

A Phase 2 Study of Poziotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Exon 20 Mutation in China and Korea

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in two patient cohorts for up to 114 previously treated NSCLC patients with any systemic therapy (57 patients with EGFR exon 20 insertion mutations and 57 patients with HER2 exon 20 insertion mutations).

Detailed description

The Screening period (Day -30 to Day -1) lasts up to approximately 30 days prior to Cycle 1, Day 1. Patients must meet all Inclusion/Exclusion Criteria to participate in the study. Eligible patients will provide written Informed Consent prior to any study procedures. Each treatment cycle is 28 calendar days in duration. There will be two patient cohorts and eligible patients will be enrolled into each cohort in parallel based on EGFR or HER2 exon 20 mutation status: * Cohort 1 : Previously treated patients with EGFR exon 20 insertion mutation positive NSCLC (N=57) * Cohort 2 : Previously treated patients with HER2 exon 20 insertion mutation positive NSCLC (N=57) Toxicity will be assessed based on the severity grade of the adverse events using CTCAE version 4.03. Poziotinib (16 mg) will be taken orally, once daily (QD) with food and a glass of water at approximately the same time each morning. All patients will be treated until disease progression, death, intolerable adverse events (AEs), or other protocol-specified reasons for patient withdrawal.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Poziotinib	The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.

Timeline

• Start date: 2019-07-30
• Primary completion: 2020-04-13
• Completion: 2020-04-13
• First posted: 2019-08-05
• Last updated: 2020-11-17

Locations

26 sites across 2 countries: China, South Korea