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

Tannenbaum-Dvir Sarah0 个研究点目标入组 10 人开始时间: 2021年10月14日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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)
•- 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

•- Women who are pregnant or breastfeeding
•- Prior chemotherapy, radiation therapy, or biologic therapy for small cell lung cancer (SCLC) for first-line treatment. 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

发起方

Tannenbaum-Dvir Sarah