Clinical Trial

Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer: A Phase Ⅲ, Randomized, Multicenter, Prospective Study

Study acronym: SACTION2401
Recruiting Phase 3
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Summary
The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant Stereotactic Body Radiotherapy (SBRT) combined with immunochemotherapy versus neoadjuvant immunochemotherapy. The main questions it aims to answer are: Dose SBRT combined with immunochemotherapy improve event-free survival? Is SBRT combined with immunochemotherapy safe enough? Participants will: Receive neoadjuvant SBRT combined with immunochemotherapy or neoadjuvant immunochemotherapy. Tumor assessment will be performed prior to surgery. Surgery will be performed within 4 to 6 weeks (+ 7 days) after completion of the last cycle of immunochemotherapy.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-09-14; most recent amendment 2025-05-22.
Status change: Not Yet Recruiting → Recruiting 2025-03-04
Trial Details
NCT Number NCT06598527
Lead Sponsor Yang Hong
Conditions Lung Cancer (NSCLC)
Enrollment 360 participants
Start Date 2024-10-15
Primary Completion 2027-01-30 (estimated)
Study Completion 2030-01-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-29