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）.
Age ranged from 18 to 75 years old (inclusive), regardless of gender;
Pathological diagnosis as sqNSCLC, with EGFR highly expressed, without other driver genes
Tumor tissue available for central laboratory testing;
Disease progression after prior anti PD-1/PD-L1 and platinum containing chemotherapy
Previously used anti EGFR, or docetaxel;
Central nervous system metastasis or meningeal metastasis;
Patients with high risk of bleeding due to tumor invasion of important arteries;
Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
Parallel
JMT101
DrugJMT101, 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.
docetaxel
Drug50 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
Drug75 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 100 mg/m2, IV infusion once every 3 weeks.
Overall response rate (ORR)
Overall Survival (OS)
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.
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.
Disease Control Rate (DCR)
Duration of response（DOR）
JMT101 Concentrations in Plasma
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This trial is not recruiting at the moment. You can still explore other options:
