A Phase 2 interventional study of Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT) in Lung Cancer and Non-small Cell Lung Cancer, sponsored by Sichuan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Sichuan University · Phase 2, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low-Dose Radiation(2Gy\*2-3d) +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.
Drug: Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)
Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)
Also known as: Drug: Tislelizumab, Drug: Chemotherapy
pCR rate
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
Time frame: From date of enrollment until one month after resection
MPR rate
mPR is defined as ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes.
Time frame: From date of enrollment until one month after resection
R0-resection rate
Time frame: From date of enrollment until one month after resection
Event-free survival (EFS)
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.
Time frame: up to 2 years
Plan to share: No
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Sichuan University