NCT06944470

JS207 Combined With Chemotherapy in Subjects With Stage II-III NSCLC

JS207 (Anti-PD-1/VEGF Bispecific Antibody) Combined With Platinum-based Doublet Chemotherapy in Subjects With Stage II-III Non-small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a phase II clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of JS207 (anti-PD-1/VEGF bispecific antibody) combined with platinum-based doublet chemotherapy in subjects with stage II-III non-small cell lung cancer. The study consists of 2 cohorts, including treatment-naïve and resectable subjects with stage II-III NSCLC (cohort 1), treatment-naïve and unresectalbe subjects with stage III NSCLC (cohort 2). Subjects in both cohorts will receive 3 cycles of JS207 + platinum-based doublet chemotherapy as neoadjuvant therapy, followed by surgery or definitive chemoradiotherapy, and then adjuvant therapy with JS207 (post-surgery) or consolidation therapy with JS207 (post-chemoradiotherapy).

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma	Carboplatin Injection: One dose of carboplatin AUC 5 IV on Day 1 of each 3-week cycle. Cisplatin injection: Cisplatin 75 mg/m2 IV on Day 1 of every 3-week cycle. Paclitaxel injection: 175 mg/m2 IV on Day 1 of each 3-week cycle. Pemetrexed Injection: Pemetrexed 500 mg/m2 IV on Day 1 of each 3-week cycle.
PROCEDURE	surgery	Subjects with surgical indications will undergo radical surgery for NSCLC，within 4-6 weeks after the last dose of neoadjuvant therapy.
RADIATION	Radiochemotherapy	If radical surgery is not suitable after MDT evaluation, the subjects will receive comprehensive treatment mainly based on radiotherapy.
DRUG	JS207	JS207 will be administered every 3 weeks for a treatment cycle of 21 days.

Timeline

• Start date: 2025-04-20
• Primary completion: 2026-09-30
• Completion: 2027-12-31
• First posted: 2025-04-25
• Last updated: 2025-04-25

Locations

1 site across 1 country: China