Neoadjuvant SBRT Followed by Sintilimab Plus Chemotherapy for N3-Positive NSCLC

This is a Phase II clinical trial evaluating the efficacy and safety of a new treatment approach for patients with locally advanced non-small cell lung cancer (NSCLC) that has spread to lymph nodes on the opposite side of the chest (known as N3 lymph node involvement). The study will enroll 28 patients aged 18 to 75 years with previously untreated, potentially resectable NSCLC classified as stage IIIB-IIIC. Participants will receive a combination of stereotactic body radiation therapy (SBRT) to the primary lung tumor, followed by two cycles of sintilimab (an immunotherapy drug) plus platinum-based chemotherapy before surgery. The main goals of the study are to see whether this treatment can shrink or eliminate cancer in the contralateral mediastinal lymph node (lymph node downstaging) and allow more patients to undergo curative surgery. Secondary goals include assessing pathological response rates, surgical outcomes, survival, and safety. Patients will be closely monitored during and after treatment, with follow-up visits planned for up to 5 years after surgery.

NCT Number	NCT07309952
Lead Sponsor	Yang Hong
Conditions	Locally Advanced Non-Small Cell Lung Cancer, Stage IIIb Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer
Enrollment	28 participants
Start Date	2025-12-31
Primary Completion	2027-10-31 (estimated)
Study Completion	2032-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-30