NCT06525350

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-12-25
• Completion: 2028-06-25
• First posted: 2024-07-29
• Last updated: 2024-07-29