A Study of BMS-986012 in Combination with Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
- Conditions
- Extensive-stage Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-001863-10-BE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
- 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 (Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) criteria
- Adequate hematologic and end organ function
- Must agree to follow specific methods of contraception, if applicable
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36
- Women who are pregnant or breastfeeding
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method