NCT04702880
Recruiting
January 11, 2021
May 3, 2022
Brief summary:
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).
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 |
Biological: BMS-986012 Specified dose on specified days Drug: Carboplatin Specified dose on specified days Drug: Etoposide Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Arm B: Carboplatin + Etoposide + Nivolumab |
Drug: Carboplatin Specified dose on specified days Drug: Etoposide Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Inclusion Criteria: Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 7th edition, Stage IV [T any, N any, M1a, or M1b], 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) Must provide a fresh tumor biopsy from the primary disease site (when possible) or from any metastatic site when the primary site is not available 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 Exclusion Criteria: Women who are pregnant or breastfeeding Prior chemotherapy, radiation therapy, or biologic therapy for small cell lung cancer (SCLC) for first-line treatment 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
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Alabama
Local Institution
Birmingham
United States, Florida
Local Institution
Tampa
United States, Kentucky
Local Institution
Lexington
United States, New Jersey
John Theurer Cancer Center
Hackensack
United States, North Carolina
Duke Cancer Institute
Durham
United States, Ohio
Local Institution
Cincinnati
United States, Ohio
University Of Cincinnati Medical Center
Cincinnati
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland
United States, Texas
Local Institution
Dallas
Australia, New South Wales
Local Institution - 0003
Westmead
Australia, Queensland
Local Institution - 0023
Greenslopes
Australia, Victoria
Local Institution
Ballarat
Australia, Victoria
Cabrini Hospital
Malvern
Australia, Western Australia
Local Institution - 0004
Murdoch
Belgium
Local Institution
Charleroi
Belgium
Local Institution
Gent
Belgium
Local Institution
Liège
Canada, Alberta
Local Institution
Edmonton
Canada, Ontario
Local Institution - 0064
Brampton
Greece
Local Institution
Athens
Greece
Local Institution
Athens
Greece
Local Institution
Irakleio
Italy
Local Institution - 0030
Peschiera del Garda
Italy
Local Institution
Pisa
Italy
Local Institution - 0029
Rozzano
Japan, Miyagi
Local Institution - 0073
Sendai
Japan, Osaka
Local Institution
Osaka-Sayama City
Japan, Osaka
Local Institution
Takatsuki
Japan
Local Institution
Saitama
Netherlands
Local Institution - 0039
Amsterdam
Netherlands
Local Institution
Arnhem
Netherlands
Local Institution
Groningen
Netherlands
Local Institution
Leiden
Netherlands
Local Institution
Nijmegen
Poland
Local Institution - 0049
Gdansk
Poland
Local Institution - 0048
Łódź
Romania
Local Institution
Bucharest
Romania
Local Institution
Cluj-Napoca
Romania
Local Institution
Craiova
Spain
Local Institution - 0007
Barcelona
Spain
Local Institution
Madrid
Spain
Local Institution
Majadahonda
Spain
Local Institution
Malaga
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb