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Report for Clinical Trial NCT04044170

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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).

NCT04044170 NSCLC
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: Poziotinib

Description: The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
Type: Drug
Group Labels: 1

Poziotinib


Primary Outcomes

Description: The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of poziotinib to the end of study.

Measure: Objective response rate (ORR)

Time: 24 months

Secondary Outcomes

Description: The proportion of subjects who achieve CR, PR, and Stable Disease (SD) by the best response from the first dose of poziotinib to the end of study.

Measure: Disease Control Rate (DCR)

Time: 24 months

Description: Number of days from the date that measurement criteria are first met for CR or PR (whichever status is recorded first) until the first subsequent date that progressive disease or death is documented.

Measure: Duration of Response (DoR)

Time: 24 months

Description: Number of days from the treatment start date to the date of documented disease progression or death due to any cause.

Measure: Progression-free Survival (PFS)

Time: 24 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

Exclusion Criteria: 1. Patient has EGFR T790M mutation or any other acquired EGFR exon 20 point mutation 2. Patient has had previous treatment with poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. --- T790M ---



HPO Nodes


HPO: