This study is a prospective, II Phase clinical trial designed to evaluate the efficacy and safety of ivonescimab as monotherapy or in combination with platinum-based chemotherapy in the perioperative treatment of resectable non-small cell lung cancer (NSCLC). Patients are stratified by PD-L1 expression level (TPS ≥50% vs. \<50%) and randomized in a 2:1 ratio to differentiated neoadjuvant treatment arms: PD-L1≥50% subgroup: Ivonescimab monotherapy (4 cycles) vs. ivonescimab + platinum-based chemotherapy (4 cycles); PD-L1\<50% subgroup: Ivonescimab + 1 cycle of chemotherapy followed by 3 cycles of monotherapy vs. ivonescimab + platinum-based chemotherapy (4 cycles). All patients subsequently receive 13 cycles of ivonescimab as adjuvant maintenance therapy postoperatively. As the first study to explore a PD-L1-directed chemotherapy de-escalation strategy, this trial aims to reduce treatment toxicity while maintaining efficacy, thereby providing a novel personalized precision therapy pathway for resectable NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Ivonescimab monotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
Ivonescimab + 1cycle of platinum-based chemotherapy followed by 3 cycles of Ivonescimab monotherapy→surgery→Ivonescimab(13 cycles)
Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
Pathological Complete Response(pCR)rate
pCR is defined as the proportion of subjects who have completed surgery and, after the completion of neoadjuvant therapy, have no residual tumor in the resected primary tumor site and lymph nodes as evaluated by local pathology experts.
Time frame: At the time of postoperative pathological assessment,Up to approximately 2 years
Major Pathological response,MPR
MPR is defined as the proportion of patients who have completed surgery and, as evaluated by local pathology experts, have residual viable tumor cells accounting for ≤10% in the resected primary tumor foci and lymph nodes.
Time frame: At the time of postoperative pathological assessment,Up to approximately 2 years
R0 resection rate
the proportion of patients who have completed surgery and achieved a pathological complete resection of the primary tumor, as evaluated by the researchers and local pathology experts.
Time frame: At the time of postoperative pathological assessment,Up to approximately 2 years
Objective Response Rate,ORR
the proportion of patients whose tumor volume reduction meets the pre-specified criteria (complete response/partial response, CR/PR) and can be maintained for the minimum required duration in accordance with recognized response evaluation criteria (such as RECIST version 1.1 for solid tumors)
Time frame: After completion of neoadjuvant therapy and before surgery,Up to approximately 2 years
24 months Event-Free Survival(EFS)%
the time from the first administration of the drug in the Full Analysis Set (FAS) to the occurrence of any of the following events, whichever comes first: disease progression evaluated according to RECIST v1.1, local recurrence, distant metastasis, or death from any cause.
Time frame: At 24 months after the first administration of study drug to the subjects
incidence rate of adverse events
Time frame: Up to approximately 2 years
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