Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)

Обзор

Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)

Подробное описание

Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)

Вмешательства

• Препарат Adebrelimab
  Adebrelimab combined with chemotherapy synchronous LDRT
• Препарат Chemotherapy
  Chemotherapy
• Лучевая терапия low dose radiotherapy
  low dose radiotherapy

Первичные конечные точки

• overall survival [Срок оценки: From date of randomization to the time when the subject died from any cause, up to approximately 36 months]

Вторичные конечные точки (9)

• Progression free survival [Срок оценки: From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months.]
• Time to second progression or death (PFS2) [Срок оценки: From date of randomization to the date of second documented progression or death from any cause, whichever occurs first, assessed up to 36 months]
• Disease control rate [Срок оценки: From date of randomization until disease progression, death, or 24 months, whichever occurs first.]
• Overall response rate (ORR) [Срок оценки: From date of randomization until disease progression, death, or 24 months, whichever occurs first]
• Duration of response (DoR) [Срок оценки: From the date of first CR/PR to the date of documented progression or death from any cause, assessed up to 36 months]
• Depth of Response [Срок оценки: From date of randomization until disease progression, death, or 24 months, whichever occurs first.]
• Post-progression survival (PPS) [Срок оценки: From the date of documented progression to the date of death from any cause, assessed up to 36 months after progression.]
• Incidence and severity of adverse events (AEs) [Срок оценки: Collect and assess safety-related test results and adverse events (AEs) for both the experimental group and the control group during the first-line and second-line treatment phases (to 90 days after the last dose of drug).]
• Incidence of serious adverse events (SAEs) [Срок оценки: Collect and assess safety-related test results and adverse events (AEs) for both the experimental group and the control group during the first-line and second-line treatment phases(before 2nd PD and 3 month afterwords).]

Критерии участия

Критерии включения

• Participants aged 18 to 75 years, regardless of gender;
• ECOG Performance Status (PS) score of 0-1;
• Expected survival duration of no less than 8 weeks;
• Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system);
• Subjects must not have received systemic therapy or radical radiotherapy for extensive SCLC prior to enrollment.

Критерии исключения

• Tissue classifications of mixed small cell lung cancer and non-small cell lung cancer;
• Patients who have undergone major surgical procedures within 28 days prior to the initial administration of the study drug, or those planning to undergo major surgery during the study period (as determined by the investigator);
• Receipt of live attenuated vaccines within 28 days before the first dose or planned for the duration of the study;
• Participation in another clinical trial within 28 days preceding initial dosing, involving any experimental agents;
• History of receiving chest radiotherapy or plans for intensive chest radiotherapy prior to systemic therapy;
• Any previous T-cell co-stimulation or immune checkpoint therapies administered;
• Documented history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\"

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

Китай · 1 центр

• West China Hospital of Sichuan University — Sichuan

Идентификаторы

NCT: NCT06610734 · SKY · 2024 Review (No. 1573)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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