Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-09; most recent amendment 2026-05-13.
Status change: Not Yet Recruiting → Recruiting 2025-06-26
Trial Details
NCT Number NCT06868836
Lead Sponsor Shanghai Junshi Bioscience Co., Ltd.
Conditions Non-squamous Non-small Cell Lung Cancer
Enrollment 78 participants
Start Date 2025-03-30
Primary Completion 2026-09-04 (estimated)
Study Completion 2028-04-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-18