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.
Voluntarily sign a written informed consent form;
Aged ≥ 18 years and ≤ 75 years , both males and females are eligible;
ECOG PS score of 0 or 1;
Patients with non-small cell lung cancer confirmed by histopathology or cytology, and with resectable clinical stage II-IIIB (T3N2) (according to the 8th edition of lung cancer TNM staging by the Union for International Cancer Control and the American Joint Committee on Cancer);
Patients with large cell carcinoma, mixed-cell lung cancer, or those with small cell lung cancer components in the mixture;
Presence of locally advanced unresectable or metastatic disease;
Palliative local treatment for non-target lesions within 2 weeks before the first administration; receipt of non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used for the treatment of thrombocytopenia) within 2 weeks before the first administration; receipt of Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first administration.
Severe infection occurred within 4 weeks before the first administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection treated with systemic anti-infective therapy within 2 weeks before the first administration (excluding antiviral therapy for hepatitis B or hepatitis C);
Parallel
Ivonescimab/surgery
Combination productIvonescimab monotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
Ivonescimab/chemotherapy/surgery
Combination productIvonescimab + 1cycle of platinum-based chemotherapy followed by 3 cycles of Ivonescimab monotherapy→surgery→Ivonescimab(13 cycles)
Ivonescimab/chemotherapy/surgery
Combination productIvonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
Ivonescimab/chemotherapy/surgery
Combination productIvonescimab + 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.
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.
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.
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)
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.
Explore biomarkers in subjects' tumor tissues that predict the efficacy of evosimab
Explore biomarkers in subjects' blood that predict the efficacy of evosimab
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