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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)
West China Hospital of Sichuan University
Chengdu, China, China
RECRUITINGpCR 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
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