Study of BMS-986012 in Subjects With Small Cell Lung Caner

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Small Cell Lung Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02949895

CA001-045

Details and patient eligibility

About

A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer

Enrollment: 7 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• Histological or cytological confirmed small cell lung cancer (SCLC)
• Eastern Cooperative Oncology Group Performance Status 0-1
• at least one measurable lesion that is not amenable to resection.
• Adequate organ function

Exclusion criteria

• Symptomatic central nervous system (CNS) metastases
• Grade ≥ 2 peripheral neuropathy
• Uncontrolled or significant cardiac disease
• Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 3 patient groups

Dose Escalation Dose 1

Experimental group

Description:

BMS-986012 Dose Escalation Dose 1

Treatment:

Drug: BMS-986012

Dose Escalation Dose 2

Experimental group

Description:

BMS-986012 Dose Escalation Dose 2

Treatment:

Drug: BMS-986012

Chemotherapy Combination

Experimental group

Description:

BMS-986012 + Cisplatin + Etoposide

Treatment:

Drug: Etoposide

Drug: BMS-986012

Drug: Cisplatin