drugset / Trial / NCT06969027

JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC

NCT06969027

Phase 2 Recruiting 84 enrolled Shanghai Junshi Bioscience Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study targets patients with in first-line treatment of advanced NSCLC, enrolling 60-84 participants. Patients will receive Arm 1: JS207 (10 mg/kg or 15 mg/kg, IV, D1) + Pemetrexed (500 mg/m2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1), Q3W, for 4 cycles followed by JS207 (10 mg/kg or 15 mg/kg, IV, D1) + pemetrexed (500 mg/m2 IV, D1), Q3W, until meeting the treatment withdrawal criteria. Arm 2: JS207 (10 mg/kg or 15 mg/kg, IV, D1) + Paclitaxel (175 mg/m2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1), Q3W, for 4 cycles followed by JS207 (10 mg/kg or 15 mg/kg, IV, D1), Q3W, until meeting the treatment withdrawal criteria.The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.

Timeline

Start
2025-06-19
Primary completion
2025-11-30
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject JS207 Monoclonal antibody 10 mg/kg Intravenous
Subject JS207 Monoclonal antibody 15 mg/kg Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Background Carboplatin Small molecule 5 unknown
Background Cisplatin Other / unclassified 75 mg/m2