Trial of BMS-986012 in Combination With Platinum and Etoposide

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Small Cell Lung Cancer

Treatments: Drug: Cisplatin; Drug: Etoposide; Drug: BMS-986012; Drug: Carboplatin; Drug: Platinum

Study type: Interventional

Funder types: Industry

Identifiers

NCT02815592

CA001-044

2016-001692-67 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Experimental Arm 1

Experimental group

Description:

BMS-986012/Cisplatin/Etoposide

Treatment:

Drug: BMS-986012

Drug: Etoposide

Drug: Cisplatin

Experimental Arm 2

Experimental group

Description:

BMS-986012/Carboplatin/Etoposide

Treatment:

Drug: Carboplatin

Drug: BMS-986012

Drug: Etoposide

Experimental Arm 3A

Experimental group

Description:

BMS-986012/Platinum/Etoposide

Treatment:

Drug: Platinum

Drug: BMS-986012

Drug: Etoposide

Active Comparator Arm 3B

Active Comparator group

Description:

Platinum/Etoposide

Treatment:

Drug: Platinum

Drug: Etoposide