Irinotecan Liposome(II) Combined With Ivonescimab as Second-line Treatment for Small Cell Lung Cancer : A Prospective, Single-arm, Multicenter Clinical Study

Обзор

This study will evaluate the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC.

Подробное описание

This is a prospective, single-arm, multicenter clinical study assessing the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy.

Вмешательства

• Препарат irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity
  Drug: ivonescimab 20mg/kg, IV, D1, Q3W Other Names: AK112 Drug: irinotecan liposome(II) 70mg/m\^2, IV, D1, Q3W

Первичные конечные точки

• Progression free survival (PFS) [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (4)

• Objective response rate（ORR） [Срок оценки: Up to approximately 2 years]
• Disease control rate (DCR) [Срок оценки: Up to approximately 2 years]
• Overall survival (OS) [Срок оценки: Up to approximately 2 years]
• Treatment related adverse events (TRAEs) [Срок оценки: Up to 30 days after last treatment]

Критерии участия

Критерии включения

• Age ≥18 years;
• Histologically or cytologically confirmed SCLC;
• Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
• The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
• Life expectancy of ≥3 months;
• At least one measurable lesion is present according to the efficacy evaluation criteria for RECIST 1.1（Lesions that have received radiotherapy within 6 months prior to the first dose cannot be used as target lesions）
• No untreated central nervous system (CNS) metastases or CNS were stable for ≥1 month after treatment
• Have adequate organ function;
• All female must have had a negative serum pregnancy test within 72 hours of the first dosing and not be lactating, and study participants and their partners must use effective contraception during the trial and for 6 months after the last dosing of the trial drug.
• Able and willing to provide a written informed consent;

Критерии исключения

• Known allergy to irinotecan hydrochloride liposome injection (II) and eboxizumab or drug excipients
• History of severe active autoimmune disease
• Participated in other drug studies within 4 weeks before enrollment
• Imaging during the screening period showed that the tumor surrounded important blood vessels or had significant necrosis and voids, and the investigators determined that entering the study would cause bleeding risk
• History of major illness within 1 year before the first medication
• History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistula, intraperitoneal abscess, or acute gastrointestinal bleeding within 6 months prior to initial administration
• History of surgery or severe trauma within 4 weeks prior to initial dosing
• Evidence and history of severe bleeding tendency;
• Participants who had received or planned to receive a live vaccine within 4 weeks prior to the first study treatment
• Patients with other cancer in 3 years,exceptions are adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• History of alcohol abuse, psychotropic substance abuse or drug abuse. Other conditions considered unsuitable for this study by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The Second Affiliated Hospital of Dalian Medical University — Dalian
• Shengjing Hospital of China Medical University — Шэньян

Публикации

• Spigel DR, Dowlati A, Chen Y, Navarro A, Yang JC, Stojanovic G, Jove M, Rich P, Andric ZG, Wu YL, Rudin CM, Chen H, Zhang L, Yeung S, Benzaghou F, Paz-Ares L, Bunn PA; RESILIENT Trial Investigators. RESILIENT Part 2: A Randomized, Open-Label Phase III Study of Liposomal Irinotecan Versus Topotecan in Adults With Relapsed Small Cell Lung Cancer. J Clin Oncol. 2024 Jul 1;42(19):2317-2326. doi: 10.12 PMID 38648575
• Chen Z, Wu L, Wang Q, Yu Y, Liu X, Ma R, Li T, Li Y, Song X, Li L, Zhao W, Wang Q, Xu X, Lu S. Brief Report: Ivonescimab Combined With Etoposide Plus Carboplatin as First-Line Treatment for Extensive-Stage SCLC: Results of a Phase 1b Clinical Trial. J Thorac Oncol. 2025 Feb;20(2):233-239. doi: 10.1016/j.jtho.2024.10.013. Epub 2024 Oct 28. PMID 39490738
• Li L, Liu T, Liu Q, Mu S, Tao H, Yang X, Li Y, Xiong Q, Wang L, Hu Y. Rechallenge of immunotherapy beyond progression in patients with extensive-stage small-cell lung cancer. Front Pharmacol. 2022 Sep 6;13:967559. doi: 10.3389/fphar.2022.967559. eCollection 2022. PMID 36147357

Идентификаторы

NCT: NCT06820762 · HR070803-SCLC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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