Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC
NCT06718309 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2024-12-05
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
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
First People's Hospital of Hangzhou
lead OTHER
Principal Investigators
-
Lucheng Zhu, MD · Hangzhou Cancer Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-24
- Primary Completion
- 2027-04-30
- Completion
- 2029-04-30
Countries
- China
Study Locations
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