MedTrace Logo

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

NCT06944470 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-04-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-20
Primary Completion
2026-09-30
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944470 on ClinicalTrials.gov