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

Extensive-stage Small Cell Lung Cancer Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Extensive-stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting