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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glumetinib tablets+HB1801 combination treatment arm | Experimental | Glumetinib tablets RP2D PO QD, HB1801 RP2D iv Q3W until a treatment discontinuation criterion is met. |
|
| Glumetinib tablets monotherapy arm | Experimental | Glumetinib tablets RP2D PO QD until a treatment discontinuation criterion is met. |
|
| Docetaxel monotherapy arm | Active Comparator | Docetaxel 75mg/m^2 iv Q3W until a treatment discontinuation criterion is met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glumetinib tablets | Drug | An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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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.
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| HB1801 (docetaxel, albumin-bound) | Drug | An improved new formulations of docetaxel |
|
| Docetaxel | Drug | A chemotherapy drug |
|
| 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 |
| MET amplification level | Up to approximately 48 months after the first participant is enrolled |
| Tumor-associated gene variations | Up to approximately 48 months after the first participant is enrolled |
| Overall survival(OS) | Up to approximately 48 months after the first participant is enrolled |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000729633 | glumetinib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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