Status:
RECRUITING
Low-Dose Radiation + SBRT + Tislelizumab Plus Platinum-based Chemotherapy in Stage ⅡA-ⅢB Non-small Cell Lung Cancer
Lead Sponsor:
Sichuan University
Conditions:
Lung Cancer
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This phase II study aims to evaluate the efficacy and safety of low-dose radiation + SBRT + Tislelizumab plus platinum-based chemotherapy as neoadjuvant therapy for stage II-III non-small cell lung ca...
Detailed Description
All eligible patients will receive LDRT combined with partial SBRT, followed by PD-1 inhibitors plus platinum-based chemotherapy, initiated within 7 days after completing radiation. PD-1 inhibitors an...
Eligibility Criteria
Inclusion
- Age ≥ 18 and ≤ 75 years;
- Patients with untreated stage IIA-IIIB non-small cell lung cancer, diagnosed cytologically or histologically (according to the AJCC 9th edition of thoracic tumor staging);
- Pulmonary lesions will be assessed as resectable or potentially resectable by a multidisciplinary team, including a thoracic surgeon;
- At least one imaging-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
- Ability to provide tumor tissue or cell wax blocks that meet quality control standards for PD-L1 expression testing.
Exclusion
- The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；
- Patients with known EGFR-sensitive mutations or ALK fusion.
- Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;
- Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;
- Active infection requiring systemic treatment.
Key Trial Info
Start Date :
July 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06877299
Start Date
July 4 2025
End Date
January 1 2028
Last Update
January 2 2026
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, China, China, 610041