Neoadjuvant low-dose radiation and SBRT with tislelizumab plus platinum chemotherapy for stage IIA–IIIB NSCLC

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

This test tries to see if giving low-dose radiation and SBRT followed by tislelizumab combined with platinum chemotherapy helps people with stage IIA–IIIB non-small cell lung cancer achieve a complete tumor response before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Drugs / interventions: Tislelizumab, chemotherapy, radiation
• Locations: 1 site (Chengdu, China)
• Trial ID: NCT06877299 on ClinicalTrials.gov

What this trial studies

This is a single-arm phase II protocol in which all eligible patients receive low-dose radiotherapy combined with partial stereotactic body radiotherapy, followed within seven days by the PD-1 inhibitor tislelizumab plus platinum-based chemotherapy given every three weeks for three cycles as neoadjuvant treatment. Surgery is planned 4 to 6 weeks (±7 days) after completing the final cycle of immunochemotherapy. The main endpoint is the pathological complete response rate in resected primary tumors and lymph nodes. Eligible patients are adults (18–75) with untreated, resectable or potentially resectable stage IIA–IIIB NSCLC, with exclusions for small cell histology, known EGFR-sensitive mutations or ALK fusions, and prior PD-1/PD-L1 therapy.

Who should consider this trial

Good fit: Adults aged 18–75 with untreated, resectable or potentially resectable stage IIA–IIIB non-small cell lung cancer, at least one measurable lesion, and available tumor tissue for PD-L1 testing who do not have EGFR or ALK alterations are ideal candidates.

Not a fit: Patients with small cell lung cancer histology, known EGFR-sensitive mutations or ALK fusions, prior PD-1/PD-L1 therapy, or unresectable disease are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could increase the proportion of patients with no remaining cancer in the tumor and lymph nodes at surgery, potentially improving long-term outcomes.

How similar studies have performed: Neoadjuvant chemo-immunotherapy has raised pCR rates in NSCLC in recent trials, and combining radiation with immunotherapy has shown promising early-phase signals but remains experimental.

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. Patients with known EGFR-sensitive mutations or ALK fusion.
3. 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;
4. 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;
5. Active infection requiring systemic treatment.

Where this trial is running

Chengdu, China

• West China Hospital of Sichuan University — Chengdu, China, China (Recruiting)

Study contacts

• Principal investigator: You Lu, MD. PhD — Study Principal Investigator
• Study coordinator: Jianxin Xue, MD. Phd

Conditions Lung Cancer; Non-small Cell Lung Cancer; Neoadjuvant; Low Dose Radiotherapy; Stereotactic Body Radiotherapy; Immunotherapy; NSCLC