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A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC

Nonsmall Cell Lung Cancer Clinical Trial

Official title:
A Phase 1/2, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10296 in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

Clinical Trial Summary

This is a Phase 1/2, open-label, multicenter study of HS-10296 with dose escalation, dose expansion and extension cohorts in locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients who have progressed following prior therapy with an epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor (TKI) agent. The study is designed to evaluate safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of once-daily and orally (PO) administered HS-10296. The overall study design is shown in the flow chart below, which consists of 3 phases: dose escalation, dose expansion and extension cohort.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02981108
Study type Interventional
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date May 8, 2017
Completion date March 31, 2023
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