drugset / Trial / 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

NCT06525350

Phase 2 Not yet recruiting 256 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
RandomizedFactorialOpen-labelTreatment

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.

Timeline

Start
2024-07
Primary completion
2026-12-25
Completion
2028-06-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Gumarontinib Small molecule Oral
Subject HB1801 Unknown Intravenous