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Active (not recruiting) Phase 2 NCT04702880

A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

Phase 2 – studying effectiveness and dosage
Conditions: Extensive-stage Small Cell Lung Cancer

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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).
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Locations 11
Australia (1)
Local Institution - 0003
Westmead , New South Wales
Belgium (1)
Local Institution - 0051
Charleroi , Hainaut
Canada (1)
Local Institution - 0012
Edmonton , Alberta
Greece (1)
Local Institution - 0045
Heraklion , Irakleío
Italy (1)
Local Institution - 0030
Peschiera del Garda
Japan (1)
Local Institution - 0073
Sendai , Miyagi
Netherlands (1)
Local Institution - 0039
Amsterdam , North Holland
Poland (1)
Local Institution - 0049
Gdansk
Romania (1)
Local Institution - 0043
Bucharest
Spain (1)
Local Institution - 0007
Barcelona , Barcelona [Barcelona]
United States (1)
Local Institution - 0075
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.03.2021
Completion date
31.12.2025
Registry ID
NCT04702880
Source
anzctr
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