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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04702880
Other study ID # CA001-050
Secondary ID 2020-001863-10U1
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 17, 2021
Est. completion date December 31, 2025

Study information

Verified date June 2024
Source Bristol-Myers Squibb
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
BMS-986012
Specified dose on specified days
Drug:
Carboplatin
Specified dose on specified days
Etoposide
Specified dose on specified days
Biological:
Nivolumab
Specified dose on specified days

Locations

Country Name City State
Australia Local Institution - 0078 Ballarat Central Victoria
Australia Local Institution - 0023 Greenslopes Queensland
Australia Local Institution - 0001 Malvern Victoria
Australia Local Institution - 0004 Murdoch Western Australia
Australia Local Institution - 0003 Westmead New South Wales
Belgium Grand Hôpital de Charleroi-Oncology & Hematology Charleroi
Belgium Local Institution - 0034 Gent
Belgium CHU de Liège Liège
Canada Local Institution - 0064 Brampton Ontario
Canada Local Institution - 0012 Edmonton Alberta
Greece Local Institution - 0036 Athens
Greece Local Institution - 0038 Athens
Greece Local Institution - 0045 Heraklion Irakleío
Italy Local Institution - 0030 Peschiera del Garda
Italy Local Institution - 0031 Pisa
Italy Local Institution - 0029 Rozzano
Japan Local Institution - 0077 Ina-machi Saitama
Japan Local Institution - 0070 Osaka-Sayama City Osaka
Japan Local Institution - 0073 Sendai Miyagi
Japan Local Institution - 0069 Takatsuki Osaka
Netherlands Amsterdam UMC, locatie VUmc Amsterdam Noord-Holland
Netherlands Rijnstate Ziekenhuis Arnhem
Netherlands Umcg, Universitair Medisch Centrum Groningen Groningen
Netherlands Local Institution - 0079 Leiden
Netherlands Local Institution Nijmegen
Poland Local Institution - 0049 Gdansk
Poland Local Institution - 0048 Lódz
Romania Local Institution - 0043 Bucharest
Romania Local Institution - 0042 Cluj
Romania Local Institution - 0041 Craiova
Spain Local Institution - 0007 Barcelona Barcelona [Barcelona]
Spain Local Institution - 0021 Madrid
Spain Local Institution - 0005 Majadahonda
Spain Local Institution - 0006 Málaga
United States Local Institution - 0075 Birmingham Alabama
United States Local Institution Cincinnati Ohio
United States Local Institution - 0060 Cincinnati Ohio
United States Local Institution - 0067 Cleveland Ohio
United States Local Institution Dallas Texas
United States Local Institution - 0002 Durham North Carolina
United States Local Institution - 0022 Hackensack New Jersey
United States Local Institution Lexington Kentucky
United States Local Institution - 0081 Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Greece,  Italy,  Japan,  Netherlands,  Poland,  Romania,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) Up to 2 years and 100 days
Primary Incidence of serious adverse events (SAEs) Up to 2 years and 128 days
Primary Incidence of AEs leading to discontinuation Up to 2 years and 128 days
Primary Incidence of deaths Up to 2 years and 128 days
Primary Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria Up to 2 years
Secondary Progression-free survival rate (PFSR) PFS by BICR based on RECIST v1.1 criteria 6 and 12 months
Secondary PFS by investigator based on RECIST v1.1 criteria Up to 2 years
Secondary PFSR PFS by investigator based on RECIST v1.1 criteria 6 and 12 months
Secondary Objective response rate (ORR) based on RECIST v1.1 criteria Up to 2 years
Secondary Time to response (TTR) based on RECIST v1.1 criteria Up to 2 years
Secondary Duration of response (DOR) based on RECIST v1.1 criteria Up to 2 years
Secondary Overall survival (OS) By arm Up to 3 years
Secondary Overall survival rate (OSR) By arm Up to 3 years
Secondary 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
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