This is a prospective, single-arm, multi-center, phase Ⅱ trial to evaluate the efficacy and safety of Polymeric Micelles paclitaxel(pm-Pac), platinum (cisplatin/carboplatin) in combination with Ivonescimab as first-line treatment in metastatic squamous NSCLC patients.
Written informed consent must be signed before implementing any trial-related procedures;
Age ≥18 years old;
Patients with histologically or cytologically confirmed metastatic or recurrent (stage IV) squamous NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging), inoperable or inappropriate for radical concurrent chemoradiotherapy, and without previous systemic treatment；. Patients with mixed histology (example adenosquamous) are allowed if there is squamous component in the specimen. PD-L1 immunohistochemical results is required before enrollment.
Blood routine test should meet the following criteria (no blood transfusion, no use of blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days before blood routine test); White blood cell count ≥3.0x10^9/L, absolute neutrophil count (ANC) ≥1.5x10^9/L，Platelet count ≥100×10^9/L Hemoglobin >9g/dL. If patients receive blood component transfusion (red blood cells, platelets, etc.) during the screening period, blood routine test should be performed again at an interval of 1 week to meet the above criteria before continuing screening.
Currently participating in interventional clinical research treatment;
Has non-squamous histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible; for non-small cell histology if there is any squamous element is present (example adenosquamous), the subject is eligible; the squamous element does not have to be predominant.
Previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1 /L1 antibodies, anti-CTLA-4 antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists (such as: Subjects of ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, etc., any treatment targeting the immune mechanism of tumor action;
known allergic or hypersensitive reactions to any investigational drug or any excipients thereof;
Single group
Ivonescimab 20mg/kg intravenous every 3 weeks
DrugIvonescimab(20mg/kg) combined with paclitaxel polymeric micelles (≤300mg/㎡) and platinum(cisplatin 75mg/㎡or carboplatin AUC5) IV every 3 weeks for 4 cycles.If patient assessment is of clinical benefit, maintenance therapy with ivonescimab or plus polymeric micelles paclitaxel(≤230mg/m\^2) can be continued based on investigator's evaluation and patient's own choice until disease progression or unacceptable toxicity. Ivonescimab is administered first, followed by paclitaxel polymeric micelles and platinum.The maximum treatment duration of ivonescimab and polymeric micelles paclitaxel is 24 months.
progression-free survival
Progression-free Survival (PFS) is defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on RECIST 1.1 assessed by investigator review.
Objective Response Rate
Objective Response Rate (ORR) Based on RECIST 1.1 assessed by investigator review, the proportion (%) of patients with confirmed best overall response of complete response (CR) or partial response (PR).
Disease Control Rate
Disease Control Rate (DCR) Based on RECIST 1.1 assessed by investigate review ,the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR), or stable disease (SD).
Duration of Response
Duration of Response (DOR) is defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 assessed by investigator review
Overall Survival
Overall Survival (OS) was measured from the date of first dose of study drug until date of death from any cause.Participants who were lost to follow-up and the participants who were alive at the date of data cutoff was censored at the date the participant was last known alive, whichever came earlier
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