Phase II Clinical Study of JS207 (PD-1/VEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy
Summary
This study targets patients with advanced NSCLC driven with positive driver genes who have failed TKI treatment, enrolling 66-78 participants. Cohort1 ：Patients will receive JS207 (10 or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin Area Under the Curve(AUC)5 or cisplatin 75 mg/m², d1) every 3 weeks for 4 cycles. Afterward, JS207 and pemetrexed will continue as maintenance therapy until discontinuation criteria are met. Cohort2 ：The treatment received was JS207 (10mg/kg, intravenous, on day 1) + JS212 (4.2mg/kg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met. The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.
Timeline
- Start
- 2025-03-30
- Primary completion
- 2026-09-04
- Completion
- 2028-04-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JS207 | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | JS207 | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | JS212 | Unknown | 4.2 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |