The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles
Pemetrexed: 500 mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. Paclitaxel: 60-75mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. Nab-paclitaxel: 260mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles.
AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China
RECRUITINGResectability rate
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Time frame: At time of surgery
Major pathological response rate (MPR)
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Time frame: At time of surgery
Pathology complete response rate(pCR)
pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.
Time frame: At time of surgery
R0 Resection rate
R0 Resection rate is defined as the percentage of patients who were able to undergo R0 Resection surgery after neoadjuvant therapy.
Time frame: At time of surgery
Perioperative G3-4 Adverse Events (AEs)
The number of participants experiencing an perioperative G3-4 AE will be assessed.
Time frame: Up to 1 month post surgery
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