NCT04702880已完成2 期
A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
Bristol-Myers Squibb77 个研究点 分布在 11 个国家目标入组 135 人开始时间: 2021年3月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 77
- 主要终点
- Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
研究概览
简要总结
The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 8th edition, Stage IV [T any, N any, M1a, M1b, or M1c], or T3-4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan)
- •Participants taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic)
- •Archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate PET tracer sub-study for whom the archived tumor specimen is optional
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
- •At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
- •Adequate hematologic and end organ function
- •Must agree to follow specific methods of contraception, if applicable
排除标准
- •Women who are pregnant or breastfeeding. Japan only: participation in the study is not allowed even if breastfeeding is suspended
- •Prior chemotherapy, radiation therapy, or biologic therapy for SCLC. Previously treated limited stage SCLC (LS-SCLC) participants are also excluded
- •Symptomatic brain or other central nervous system (CNS) metastases
- •Paraneoplastic autoimmune syndrome requiring systemic treatment
- •History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
- •Grade ≥ 2 peripheral sensory neuropathy at study entry
- •Significant uncontrolled cardiovascular disease
- •Active, known or suspected autoimmune disease or inflammatory disorder
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm B: Carboplatin + Etoposide + Nivolumab
Experimental
干预措施: Nivolumab (Biological)
Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
Experimental
干预措施: BMS-986012 (Biological)
Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
Experimental
干预措施: Carboplatin (Drug)
Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
Experimental
干预措施: Nivolumab (Biological)
Arm B: Carboplatin + Etoposide + Nivolumab
Experimental
干预措施: Carboplatin (Drug)
Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
Experimental
干预措施: Etoposide (Drug)
Arm B: Carboplatin + Etoposide + Nivolumab
Experimental
干预措施: Etoposide (Drug)
结局指标
主要结局
Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
时间窗: Up to 2 years
Incidence of adverse events (AEs)
时间窗: Up to 2 years and 100 days
Incidence of serious adverse events (SAEs)
时间窗: Up to 2 years and 128 days
Incidence of AEs leading to discontinuation
时间窗: Up to 2 years and 128 days
Incidence of deaths
时间窗: Up to 2 years and 128 days
次要结局
- Duration of response (DOR) based on RECIST v1.1 criteria(Up to 2 years)
- Overall survival (OS)(Up to 3 years)
- Time to response (TTR) based on RECIST v1.1 criteria(Up to 2 years)
- Progression-free survival rate (PFSR)(6 and 12 months)
- PFS by investigator based on RECIST v1.1 criteria(Up to 2 years)
- PFSR(6 and 12 months)
- Objective response rate (ORR) based on RECIST v1.1 criteria(Up to 2 years)
- Overall survival rate (OSR)(Up to 3 years)
- Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs)(Up to 2 years)
研究者
研究点 (77)
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