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Study of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:
A Phase Ib Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC.

Clinical Trial Summary

This study is conducted to determine the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-10241 when given together with Almonertinib in patients with EGFRm+ advanced NSCLC.

Clinical Trial Description

This is a phase Ⅰb, multicenter study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HS-10241 administered orally in combination with Almonertinib in patients with EGFRm+ locally advanced or metastatic NSCLC who have progressed following prior EGFR-TKI therapy. The study consist of two parts: Part 1 is the dose escalation period to observe the safety, tolerance, PK characteristics and preliminary anti-tumor activity, and determine the maximum tolerated dose (MTD) or maximum applicable dose (MAD) of combined administration; Part 2 is the dose expansion period to select appropriate doses in different target populations and further evaluate the efficacy, safety, tolerance and PK characteristics of combined administration, and determine the phase II recommended dose (RP2D). All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Patients of this study will be permitted to continue therapy with assessments for progression once every 8 weeks, if the product is well tolerated and the subject has stable disease or better. Survival follow-up is recommended once every 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05430386
Study type Interventional
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact Shun Lu, MD
Phone 86-21-22200000
Email shun_lu@hotmail.com
Status Recruiting
Phase Phase 1
Start date January 5, 2022
Completion date December 31, 2023
View Details
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