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Trial of BMS-986012 in Combination With Platinum and Etoposide

NCT ID: NCT02815592

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-28

Study Completion Date

2024-08-06

Brief Summary

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The purpose of this this study is to administer BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.

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Detailed Description

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Arm 1

BMS-986012/Cisplatin/Etoposide

Group Type EXPERIMENTAL

BMS-986012

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Experimental Arm 2

BMS-986012/Carboplatin/Etoposide

Group Type EXPERIMENTAL

BMS-986012

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Experimental Arm 3A

BMS-986012/Platinum/Etoposide

Group Type EXPERIMENTAL

BMS-986012

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Platinum

Intervention Type DRUG

Active Comparator Arm 3B

Platinum/Etoposide

Group Type ACTIVE_COMPARATOR

Etoposide

Intervention Type DRUG

Platinum

Intervention Type DRUG

Interventions

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BMS-986012

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Platinum

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and Females 18 years of age or older
* Pulmonary SCLC documented by histology or cytology
* Extensive disease (Stage IV) SCLC
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria

* Prior systemic therapy for lung cancer
* Symptomatic brain metastases
* Grade 2 peripheral neuropathy
* Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV
* Other active malignancies or prior malignancy within 2 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0002

Barcelona, , Spain

Site Status

Local Institution - 0004

Madrid, , Spain

Site Status

Local Institution - 0003

Majadahonda - Madrid, , Spain

Site Status

Local Institution - 0010

Málaga, , Spain

Site Status

Countries

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Spain

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsclinicaltrials.com/us/en/home

BMS Clinical Trial Patient Recruiting

Other Identifiers

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2016-001692-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA001-044

Identifier Type: -

Identifier Source: org_study_id

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