Trial of BMS-986012 in Combination With Platinum and Etoposide

Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 1/2 Randomized Trial of BMS-986012 in Combination With Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02815592
• Other study ID #: CA001-044
• Secondary ID: 2016-001692-67
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 28, 2016
• Est. completion date: June 3, 2024

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 3, 2024
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• BMS-986012

• Cisplatin

• Etoposide

• Platinum

• Carboplatin

Locations

Country	Name	City	State
Spain	Local Institution - 0002	Barcelona
Spain	Local Institution - 0004	Madrid
Spain	Local Institution - 0003	Majadahonda - Madrid
Spain	Local Institution - 0010	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)		Cycle 1, Day 1 up to approximately 26 months.
Primary	Number of participants with serious adverse events (SAEs )		Date of enrollment up to approximately 26 months.
Primary	Discontinuations due to AEs		Cycle 1, Day 1 up to approximately 26 months.
Primary	Number of participants who died due to AEs		Cycle 1, Day 1 up to approximately 26 months.
Primary	Number of participants with laboratory toxicity grade shift from baseline		Cycle 1, Day 1 up to approximately 26 months.
Primary	Progression Free Survival		From date of first dose or randomization until date of confirmed disease progression, up to 2 years
Secondary	Maximum observed serum concentration(Cmax)		Cycle 1 Day 1 up to 60 days after last dose
Secondary	Time of maximum observed serum concentration(Tmax)		Cycle 1 Day 1 up to 60 days after last dose
Secondary	Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))		Cycle 1 Day 1 up to 60 days after last dose
Secondary	Observed serum concentration at the end of a dosing interval(Ctau)		Cycle 1 Day 1 up to 60 days after last dose
Secondary	Area under the concentration-time curve in 1 dosing interval(AUC(TAU))		Cycle 1 Day 1 up to 60 days after last dose
Secondary	Characterization of Immunogenicity	Anti-Drug Antibodies	Cycle 1 Day 1 up to 60 days after last dose

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting