NCT07493980

Study on the Efficacy and Safety of JSKN016 as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients

Study on the Efficacy and Safety of JSKN016 Combined With Toripalimab and Carboplatin as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of JSKN016 combined with toripalimab and carboplatin as a neoadjuvant treatment regimen in patients with resectable stage II-III NSCLC.

Detailed description

Enrolled subjects were histologically confirmed resectable stage II, IIIA, and IIIB NSCLC (according to the 9th edition AJCC Lung Cancer TNM Staging System), with no evidence of distant metastasis and no evidence of unresectable local regional tumor extension.

Conditions

• NSCLC Stage II

Interventions

Type	Name	Description
DRUG	JSKN016 + Toripalimab + Carboplatin	During the neoadjuvant treatment phase, enrolled subjects will receive combination therapy with JSKN016 (4 mg/kg) + toripalimab (240 mg) + carboplatin (AUC 5) in 3-week cycles, with a maximum of 4 cycles. Subjects meeting surgical criteria will undergo surgery within 8 weeks after the last neoadjuvant treatment cycle. A preoperative visit will be conducted 1 week (±1 week) prior to surgery. Surgery may be advanced if the investigator determines the subject is stable and fit for surgery, provided it occurs at least 7 days after the last study drug administration. Resected tumor specimens will undergo assessment of surgical margins and extent of resection (R0, R1/R2). Tumor tissue will be evaluated for pathological response (MPR and pCR). Subsequent adjuvant therapy will follow standard clinical practice.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China