NCT06718309

Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC

A Prospective Cohort Study of Chemotherapy Plus Immunotherapy Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Patients With Resectable Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, patients with EGFR/ALK wild-type, resectable locally advanced NSCLC are expected to receive 1 cycle of chemoimmunotherapy as neoadjuvant therapy, followed by SBRT to the primary lung lesion, and chemoimmunotherapy for 2 cycles. Surgical treatment will be given within 4-6 weeks after the last cycle of chemoimmunotherapy, then immunotherapy maintenance for 1 year.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Chemotherapy	Patients with squamous cell carcinoma can choose paclitaxel + cisplatin/carboplatin and patients with nonsquamous cell carcinoma can choose pemetrexed + cisplatin/carboplatin. The chemotherapy treatment lasts 3 cycles.
DRUG	Immunotherapy	Investigators choose PD-1 or PD-L1 according to drug indication and the immunotherapy lasts 3 cycles preoperatively and 1 year after surgery.
PROCEDURE	Radical resection of lung cancer	Radical resection of lung cancer with lymph node dissection
RADIATION	SBRT	SBRT for primary lung lesion 8Gy\*3F after first cycle of chemoimmunotherapy

Timeline

• Start date: 2024-04-24
• Primary completion: 2027-04-30
• Completion: 2029-04-30
• First posted: 2024-12-05
• Last updated: 2024-12-05

Locations

1 site across 1 country: China