Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer

Обзор

Patients with extensive-stage small-cell lung cancer (ES-SCLC) have poor prognosis, with limited treatment options. Chemo-immunotherapy is the standard 1st-line therapy for patients with ES-SCLC.When 4 cycles of etoposide+carboplatin (EC) or etoposide+cisplatin(EP) chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy. In this study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC chemotherapy plus Adebrelimab, participants with response（PR/CR/SD）will receive concurrent radiotherapy and 2 cycles of EC chemotherapy plus Adebrelimab, then maintenance therapy with Adebrelimab （Q3W）. The purpose of this study is to explore the safety and efficacy of Adebrelimab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.

Подробное описание

Participants receive EC chemotherapy combined with Adebrelimab for 2 cycles, and the efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy combined with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy + Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Вмешательства

• Препарат Adebrelimab
  Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.
• Лучевая терапия Radiation Therapy
  Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.
• Препарат etoposide, carboplatin(EC)
  Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Первичные конечные точки

• 6-m PFS rate [Срок оценки: 6 months]

Вторичные конечные точки (5)

• ORR [Срок оценки: up to 24 months.]
• PFS [Срок оценки: From date of the first treatment to the first documented disease progression, assessed up to 24 months]
• OS [Срок оценки: From date of the first treatment to death due to any cause, assessed up to 24 months]
• 12-m PFS rate [Срок оценки: 12 months]
• AEs [Срок оценки: up to 24 months]

Критерии участия

Критерии включения

• Aged 18-75 years;
• Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system) ;
• Must sign a written informed consent form prior to any study specific procedures;
• No prior treatment for ES-SCLC;
• No more than 5 lesions (including metastases),and at least one measurable lesion that meets RECIST 1.1 evaluation criteria;
• Life expectancy more than 3 months;
• ECOG PS 0-1

Критерии исключения

• Previous treatment with radiochemotherapy for limited-stage small cell lung cancer;
• Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy ;
• Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;
• Active brain metastases, Leptomeningeal metastasis(untreated central nervous system (CNS) metastases unless asymptomatic and lesion size<1cm;
• Patients with spinal cord compression;
• Patients with multiple liver metastases(except isolated lesion and lesion size<2cm);
• Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
• The investigator judges that there are any patients who endanger the patient's safety, interfere with the study assessment, and have poor compliance.

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

• Henan Cancer Hospital — Чжэнчжоу
• Tongji Hospital, Tongji Medical College，Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT06236997 · MA-SCLC-II-011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗