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

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

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Able to understand and voluntarily sign a written informed consent form;

2. Age ≥ 18 years old, gender unlimited;

3. Unresectable locally advanced or metastatic non-small cell lung cancer (IIIB, IIIC, or IV according to the 8th edition TNM staging standards of IASLC) confirmed by histology or cytology;

4. Participants must provide tumor tissue samples that meet the testing requirements of the central laboratory, or agree to accept the tumor tissue biopsy, used for central laboratory testing of MET expression and amplification, and the development of MET associated diagnostic reagents;

Disqualifiers

1. Previously received MET-targeted drug therapy;

2. Previous treatments included docetaxel;

3. Existence of meningeal metastasis, spinal cord compression, or active and untreated brain metastasis;

4. Imaging evidence of clear tumor cavity, capsule or large vessel invasion, and tumor adjacent to important vascular structures , Which has been determined by researchers that there is a risk of fatal bleeding;

Trial design

Design model

Factorial

Treatments tested in this trial

Glumetinib tablets
Drug
An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor
HB1801 (docetaxel, albumin-bound）
Drug
An improved new formulations of docetaxel
Docetaxel
Drug
A chemotherapy drug

Treatment groups

256 Participants

are divided into 3 treatment groups

Group A: Glumetinib tablets+HB1801 combination treatment armExperimental treatment 2 interventions

Group B: Glumetinib tablets monotherapy armExperimental treatment 1 intervention

Group C: Docetaxel monotherapy armActive comparator 1 intervention