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This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer (sqNSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMT101+ docetaxel | Experimental |
| |
| JMT101+HB1801 | Experimental |
| |
| HB1801 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMT101 | Drug | JMT101, 6 mg/kg, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). or 9 mg/kg, IV infusion once every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Up to approximately 2 years | |
| Overall Survival (OS) | Up to approximately 3 years | |
| Incidence and severity of adverse events (AE) and serious adverse events (SAE) | Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. | Up to approximately 2 years |
| Disease Control Rate (DCR) |
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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 |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, M.D. | Sun Yat-sen University | Principal Investigator |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| docetaxel | Drug | 50 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 75 mg/m2, IV infusion once every 3 weeks. |
|
| HB1801 | Drug | 75 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 100 mg/m2, IV infusion once every 3 weeks. |
|
| Up to approximately 2 years |
| Duration of response(DOR) | Up to approximately 2 years |
| JMT101 Concentrations in Plasma | Up to approximately 2 years |
| Total and Free Docetaxel Concentrations in Plasma | Up to approximately 2 years |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |