Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

Официальное название

Evaluate the Efficacy and Safety of Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

Обзор

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.

Вмешательства

• Комбинированный продукт Ivonescimab/surgery
  Ivonescimab monotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
• Комбинированный продукт Ivonescimab/chemotherapy/surgery
  Ivonescimab + 1cycle of platinum-based chemotherapy followed by 3 cycles of Ivonescimab monotherapy→surgery→Ivonescimab(13 cycles)
• Комбинированный продукт Ivonescimab/chemotherapy/surgery
  Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
• Комбинированный продукт Ivonescimab/chemotherapy/surgery
  Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)

Первичные конечные точки

• Pathological Complete Response（pCR）rate [Срок оценки: At the time of postoperative pathological assessment，Up to approximately 2 years]

Вторичные конечные точки (5)

• Major Pathological response，MPR [Срок оценки: At the time of postoperative pathological assessment，Up to approximately 2 years]
• R0 resection rate [Срок оценки: At the time of postoperative pathological assessment，Up to approximately 2 years]
• Objective Response Rate，ORR [Срок оценки: After completion of neoadjuvant therapy and before surgery，Up to approximately 2 years]
• 24 months Event-Free Survival（EFS）% [Срок оценки: At 24 months after the first administration of study drug to the subjects]
• incidence rate of adverse events [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• 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);
• No prior anti-tumor treatment has been received;
• No known EGFR sensitive mutations/ALK gene translocations;

Критерии исключения

• 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);
• Major surgical operation or severe trauma occurred within 4 weeks before the first administration, or those with a plan for major surgical operation within 4 weeks after the first administration (determined by the researcher); minor local surgery performed within 3 days before the first administration (excluding peripherally inserted central catheterization and venous access port implantation);
• History of severe bleeding tendency or coagulation dysfunction; presence of clinically significant bleeding symptoms within 1 month before the first administration, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or expectorating ≥ 1 teaspoon of fresh blood or small blood clots, or coughing up only blood without sputum; those with blood-tinged sputum are allowed to enroll), nasal bleeding (excluding epistaxis and retrograde epistaxis); receipt of continuous antiplatelet or anticoagulant therapy within 10 days before the first administration.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07241819 · 2025YJZ75-ZY01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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