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 | Not Yet Recruiting Phase 2

• 1 other identifier: SYH2065-001
• Study Type: interventional
• Target: 256
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (4)

• Dose-limiting toxicity(DLT) occurrence and incidence

  Up to approximately 48 months after the first participant is enrolled

• Recommended phase 2 dose(RP2D) of the combination therapy

  Up to approximately 48 months after the first participant is enrolled

• Adverse events (AE) and serious adverse events (SAE) occurrence and incidence

  Up to approximately 48 months after the first participant is enrolled

• Objective response rate (ORR) per RECIST 1.1

  Up to approximately 48 months after the first participant is enrolled

Secondary Outcomes (8)

• Disease control rate (DCR) per RECIST 1.1

  Up to approximately 48 months after the first participant is enrolled

• Duration of response (DoR) per RECIST 1.1

  Up to approximately 48 months after the first participant is enrolled

• Progression free survival (PFS) per RECIST 1.1

  Up to approximately 48 months after the first participant is enrolled

• Blood drug concentrations of glumetinib and HB1801

  Up to approximately 48 months after the first participant is enrolled

• MET expression level

  Up to approximately 48 months after the first participant is enrolled

Study Arms (3)

Glumetinib tablets+HB1801 combination treatment arm

EXPERIMENTAL

Glumetinib tablets RP2D PO QD, HB1801 RP2D iv Q3W until a treatment discontinuation criterion is met.

Drug: Glumetinib tablets; Drug: HB1801 (docetaxel, albumin-bound）

Glumetinib tablets monotherapy arm

EXPERIMENTAL

Glumetinib tablets RP2D PO QD until a treatment discontinuation criterion is met.

Drug: Glumetinib tablets

Docetaxel monotherapy arm

ACTIVE COMPARATOR

Docetaxel 75mg/m\^2 iv Q3W until a treatment discontinuation criterion is met.

Drug: Docetaxel

Interventions

Glumetinib tablets DRUG

An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor

Glumetinib tablets monotherapy arm; Glumetinib tablets+HB1801 combination treatment arm

HB1801 (docetaxel, albumin-bound） DRUG

An improved new formulations of docetaxel

Glumetinib tablets+HB1801 combination treatment arm

Docetaxel DRUG

A chemotherapy drug

Docetaxel monotherapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Able to understand and voluntarily sign a written informed consent form;
• \. Age ≥ 18 years old, gender unlimited;
• \. 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;
• \. 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;
• \. Confirmation of MET overexpression in tumor tissue specimens through the central laboratory designated by the sponsor;
• \. Driver genes alterations must be negative (including EGFR mutations, ALK fusion, ROS1 rearrangement fusion, BRAF V600 mutation, NTRK fusion, MET 14 exon skipping mutation, RET rearrangement, HER2 Mutations, KRAS activation mutations, etc.);
• \. Previously received immunotherapy with PD-1/PD-L1 monoclonal antibody and platinum-containing chemotherapy (combination therapy or sequential therapy);
• \. At least one measurable lesion exists at the baseline that meets the definition of RECIST 1.1;
• \. ECOG performance score of 0 or 1;
• Expected survival time ≥ 3 months;
• Adequate organs and bone marrow function within 7 days prior to initial administration.

You may not qualify if:

• \. Previously received MET-targeted drug therapy;
• \. Previous treatments included docetaxel;
• \. Existence of meningeal metastasis, spinal cord compression, or active and untreated brain metastasis;
• \. 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;
• \. Suffering from central squamous cell lung cancer with cavities or hemoptysis (\>50 mL/d);
• \. Within 14 days before the first administration, there is an uncontrollable accumulation of serous cavity effusion that requires frequent drainage or medical intervention;
• \. Adverse reactions from previous anti-tumor treatments (including radiotherapy) have not yet recovered to ≤ level 1(according to CTCAE 5.0) or baseline level (excluding toxicity assessed by researchers as having no safety risk such as hair loss, fatigue, pigmentation, etc);
• \. Suffering from other malignant tumors within 5 years prior to the first administration. (Except already treated local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ);
• \. Received any systemic anti-tumor therapy within 28 days or 5 half-lives prior to initial administration (whichever is shorter) treatment, including chemotherapy, targeted therapy, biological therapy, immunotherapy, immunomodulatory drugs (including thymosin, interleukin-2, interferon, tumor necrosis factor, etc.), or other research drugs;
• \. Received radiation therapy involving the chest cavity within 28 days prior to the first administration, o received radiation therapy not involving the chest cavity within 14 days prior to the first administration;
• \. Received Chinese herbal medicine or traditional Chinese patent medicines for tumor control within 14 days before the first administration;
• \. Received potent cytochrome P450 3A4 (CYP3A4) inhibitor or induction within 14 days prior to initial administration or Patients who cannot suspend the use of CYP3A4 potent inhibitors during the study;
• \. Having undergone major surgery (excluding biopsy) or severe traumatic damage within 28 days before the first administration, or expected to undergo major surgery during the study;
• \. A history of gastrointestinal perforation and/or fistula, severe gastrointestinal ulcers or surgery, gastrointestinal dysfunction, or other diseases that may affect the absorption of experimental drugs within 6 months prior to the first administration;
• \. Existence of ≥ grade 2 edema and lymphedema that cannot be relieved through clinical intervention;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Recurrence

Interventions

glumetinib; Docetaxel

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In stage 2, participants who meet the eligibility criteria are randomly assigned to the experimental group (glumetinib tablets+HB1801), factorial group (glumetinib tablets), and control group (docetaxel) in a 2:1:1 ratio.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 29, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): June 25, 2028
• Last Updated: July 29, 2024

Record last verified: 2024-07