Neoadjuvant EGFR TKI therapy targeting EGFR mutation has some problems failure to fulfill clinical requirements such as low MPR rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.This study hypothesized that Tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage II-IIIA non-squamous NSCLC with EGFR-mutant PD-L1 expression ≥1% could significantly improve the pathological response rate after neoadjuvant therapy, improve the surgical complete resection rate, reduce perioperative complications and do not increase the surgical difficulty.In this study, biomarker analysis is going to explore the possible direction of neoadjuvant therapy population screening, and to explore a possible method for the efficacy and safety of neoadjuvant immunotherapy in clinical stage II-IIIA non-squamous non-small cell lung cancer with EGFR mutation and expression of PD-L1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
200 mg ,intravenous injection ,Q3W 2-4 cycles
500 mg/m2,intravenous injection ,Q3W 2-4 cycles
60-75mg/m2 ,intravenous injection ,Q3W 2-4 cycles
AUC(4-5) ,intravenous injection ,Q3W 2-4 cycles
First Affiliated Hospital, Guangzhou Medical University
Guangzhou, Please Select, China
RECRUITINGMajor pathologic response rate (MPR) (proportion of patients with no more than 10% remaining live tumor cells in the resected primary tumor and in all resected lymph nodes)
MPR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated
Time frame: 15-18 weeks after enrollment
ORR: Proportion of patients who achieved complete response (CR) or partial response (PR) among all randomized patients with measurable disease at baseline assessed according to RECIST version 1.1
To evaluate objective response rate (ORR) in neoadjuvant treatment
Time frame: 6-12weeks after enrollment
pCR: proportion of patients with no residual tumor in resected primary tumor and lymph nodes
pCR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated
Time frame: 15-18 weeks after enrollment
Descending rate of lymph nodes
Proportion of patients whose pathologic lymph node stage was reduced to N1/N0 by baseline radiographic assessment of N2 or N1
Time frame: 15-18 weeks after enrollment
Number of Participants with Adverse Events
To evaluate the safety profile(Number of Participants with Adverse Events)
Time frame: through study completion, an average of 35weeks
The time of surgery delay
evaluate the interval time from the completation of last neoadjuvant therapy to surgery
Time frame: 4-6weeks after completation of the last neoadjuvant therapy
minimally invasive surgery rate
explore different surgery manner rate after neoadjuvant
Time frame: 4-6weeks after completation of the last neoadjuvant therapy
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