Clinical trial NCT06877299: Low-Dose Radiation + SBRT + Tislelizumab Plus Platinum-based Chemotherapy in Stage ⅡA-ⅢB Non-small Cell Lung Cancer
Official title: Low-Dose Radiation + Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy As Neoadjuvant Therapy in Patients with Resectable StageⅡA-ⅢB Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Non-small Cell Lung Cancer
Keywords: NSCNC
Neoadjuvant
Low Dose Radiotherapy
Stereotactic Body Radiotherapy
Immunotherapy
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pCR rate
timeFrame: From date of enrollment until one month after resection
Secondary outcomes:
measure: MPR rate
timeFrame: From date of enrollment until one month after resection
measure: R0-resection rate
timeFrame: From date of enrollment until one month after resection
measure: Event-free survival (EFS)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
Study officials:
affiliation: Study Principal Investigator
name: You Lu, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
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