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NOT YET RECRUITING
NCT06525350
PHASE2

A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel(Albumin Bound)Verse Docetaxel for the Treatment of MET-overexpressed Non-small Cell Lung Cancer

Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

This study consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (randomized controlled study). The main purpose of Stage 1 is to preliminarily evaluate the safety and tolerability of the combination of glumetinib Tablets and Docetaxel for Injection(Albumin Bound)(HB1801) in the treatment of MET-overexpressed non-small cell lung cancer (NSCLC); The main purpose of Stage 2 is to evaluate the efficacy of the combination of glumetinib tablets and HB1801 compared to glumetinib tablets monotherapy or docetaxel in the treatment of MET-expressed NSCLC.

Official title: A Randomized, Controlled, Open-label Phase Ⅱ Study to Evaluate the Safety, Tolerability, and Efficacy of the Combination of Glumetinib Tablets and Docetaxel for Injection(Albumin Bound)Verse Docetaxel in the Treatment of Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer Patients With MET Overexpression

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2024-07

Completion Date

2028-06-25

Last Updated

2024-07-29

Healthy Volunteers

No

Interventions

DRUG

Glumetinib tablets

An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor

DRUG

HB1801 (docetaxel, albumin-bound)

An improved new formulations of docetaxel

DRUG

Docetaxel

A chemotherapy drug