Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

Обзор

This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).

Подробное описание

This is a phase II open-label, single-arm, multi-center study to evaluate the efficacy and safety of adjuvant immunotherapy with chemotherapy for completely resected pathologic T1-T2, N0-N1, M0 small cell lung cancer (SCLC). The statistical design includes a predefined range of alpha and power to detect an improvement in 2-year disease free survival (DFS).

Вмешательства

• Препарат Durvalumab 50 MG/ML
  Following surgical removal of their small-cell lung cancer, participants will receive a combination of 1500 mg durvalumab and cisplatin 75 mg/m2 or carboplatin AUC 5 on day 1, and etoposide 100 mg/m2 on days 1, 2, and 3, every 3 weeks for 4 cycles (a total of 12 weeks). Following the combination of chemotherapy and immunotherapy, participants will then receive 1500 mg durvalumab every 4 weeks for 9 cycles (a total of 36 weeks).

Первичные конечные точки

• Disease free survival (DFS) [Срок оценки: 2 years]

Вторичные конечные точки (3)

• Overall survival (OS) [Срок оценки: 3 years]
• Safety of the regimen [Срок оценки: 1 year]
• Safety of the regimen [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Body weight >30 kg.
• Must have a life expectancy of at least 12 weeks.
• Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition.
• Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment.
• Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required.
• No prior systemic therapies, for small cell lung cancer.
• Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer.
• ECOG performance status 0-1.

Критерии исключения

• Patients who are receiving any other investigational agents.
• Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.
• Prior treatment with durvalumab.
• History of another primary malignancy except for:

• Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Superficial bladder cancer without active disease after treatment.
• Low grade prostate cancer without indication for active treatment.
• Adequately treated carcinoma in situ without evidence of disease.
• Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months.
• Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication.
• Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.

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

США · 3 центра

• University of Illinois Chicago — Chicago
• Dana Farber Cancer Institute — Boston
• University of Virginia Comprehensive Cancer Center — Charlottesville

Идентификаторы

NCT: NCT07149363 · AFT-61

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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