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NOT YET RECRUITING
NCT06944470
PHASE2

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

Sponsor: Shanghai Junshi Bioscience Co., Ltd.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2025-04-20

Completion Date

2027-12-31

Last Updated

2025-04-25

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China