This project intends to study the efficacy and safety of Iparomlimab and Tuvonralimab with or without chemotherapyin the perioperative treatment of NSCLC
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
PD-1/CTLA-4
PD-1/CTLA4 combined chemotherapy drugs
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union
Beijing, China
RECRUITINGPathologic complete response (pCR)
pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects,achieving complete histological regression with no available tumor cells
Time frame: 4 weeks after surgery
Major Pathological Response Rate (MPR)
The MPR is defined as the percentage of subjects who underwent lung cancer resection with ≤10% residual viable tumor cells in the postoperative tumor bed (regardless of the presence or absence of residual viable tumor cells in the lymph nodes).
Time frame: 4 weeks after surgery
Objective Response Rate (ORR)
The proportion of subjects who received neoadjuvant therapy and had at least one post-baseline imaging assessment, achieving a best response of complete response (CR) or partial response (PR) on preoperative imaging. For subjects who did not undergo surgical resection, the results from the first planned post-baseline imaging assessment were used for evaluation; confirmation of the best response was not required
Time frame: After completion of neoadjuvant therapy, before surgery
R0 Resection Rate
The percentage of subjects who underwent resection and achieved complete resection (R0) among all subjects who received lung cancer surgery.
Time frame: 2 weeks after surgery
2-Year Event-Free Survival Rate (EFS)
Defined as the time from the date of first study treatment administration to the date of occurrence of any of the following events: disease progression or deterioration leading to inability to undergo surgery, attempted surgery but abandoned due to unresectable tumor or disease deterioration, postoperative disease progression or recurrence (RECIST 1.1), disease progression or recurrence without surgery, or death from any cause.
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Time frame: up to 2 years