Low-Dose Radiation + SBRT + Tislelizumab Plus Platinum-based Chemotherapy in Stage ⅡA-ⅢB Non-small Cell Lung Cancer

Phase 2

Not yet recruiting

• Conditions: Lung Cancer; Non-small Cell Lung Cancer
• Interventions: Drug: Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)

• Registration Number: NCT06877299
• Lead Sponsor: Sichuan University

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 cancer.

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 and chemotherapy will be administered at the recommended doses according to the instruction manual every 3 weeks, with 3 cycles planned as neoadjuvant therapy. Surgery will be performed within 4 to 6 weeks (+7 days) after completing the final cycle of immunochemotherapy.

Main objective and endpoint: the rate of pathological complete response (pCR) in the resected primary tumor and lymph nodes.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26
• Study Start: 2025-04-10
• Primary Completion: 2027-07-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age ≥ 18 and ≤ 75 years;
2. 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);
3. Pulmonary lesions will be assessed as resectable or potentially resectable by a multidisciplinary team, including a thoracic surgeon;
4. At least one imaging-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
5. Ability to provide tumor tissue or cell wax blocks that meet quality control standards for PD-L1 expression testing.

Exclusion Criteria

1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；
2. 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;
3. 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;
4. Active infection requiring systemic treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation therapy combined with PD-1 inhibitor and chemotherapy group	Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)	Low-Dose Radiation(2Gy\*2d) +Stereotactic body radiation therapy (10Gy\*3d) followed by Tislelizumab (200mg) with platinum-based doublet chemotherapy administered pre-operatively every 3 weeks for 3 cycles before surgical resection.

Primary Outcome Measures

Name	Time	Method
pCR rate	From date of enrollment until one month after resection	pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin stained slides of the resected lung specimen and lymph nodes following completion of neoadjuvant therapy

Secondary Outcome Measures

Name	Time	Method
MPR rate	From date of enrollment until one month after resection	mPR is defined as ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes.
R0-resection rate	From date of enrollment until one month after resection
Event-free survival (EFS)	up to 2 years	EFS is defined as the time from enrollment to radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, China