Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Durvalumab and one of the two chemotherapy combinations: cisplatin or carboplatin, and etoposide
65 participants will be enrolled.
干预措施: Durvalumab 50 MG/ML (Drug)
结局指标
主要结局
Disease free survival (DFS)
时间窗: 2 years
To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved disease free survival (DFS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. DFS is measured in months from the time of surgery.
次要结局
- Overall survival (OS)(3 years)
- Safety of the regimen(5 years)
- Safety of the regimen(1 year)