Trial of BMS-986012 in Combination With Platinum and Etoposide

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02815592
Collaborator
(none)
14
Enrollment
4
Locations
4
Arms
62.9
Anticipated Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 28, 2016
Actual Primary Completion Date :
Dec 15, 2019
Anticipated Study Completion Date :
Feb 25, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Experimental Arm 1

BMS-986012/Cisplatin/Etoposide

Drug: BMS-986012

Drug: Cisplatin

Drug: Etoposide

Experimental: Experimental Arm 2

BMS-986012/Carboplatin/Etoposide

Drug: BMS-986012

Drug: Etoposide

Drug: Carboplatin

Experimental: Experimental Arm 3A

BMS-986012/Platinum/Etoposide

Drug: BMS-986012

Drug: Etoposide

Drug: Platinum

Active Comparator: Active Comparator Arm 3B

Platinum/Etoposide

Drug: Etoposide

Drug: Platinum

Outcome Measures

Primary Outcome Measures

  1. Number of participants with adverse events (AEs) [Cycle 1, Day 1 up to approximately 26 months.]

  2. Number of participants with serious adverse events (SAEs ) [Date of enrollment up to approximately 26 months.]

  3. Discontinuations due to AEs [Cycle 1, Day 1 up to approximately 26 months.]

  4. Number of participants who died due to AEs [Cycle 1, Day 1 up to approximately 26 months.]

  5. Number of participants with laboratory toxicity grade shift from baseline [Cycle 1, Day 1 up to approximately 26 months.]

  6. Progression Free Survival [From date of first dose or randomization until date of confirmed disease progression, up to 2 years]

Secondary Outcome Measures

  1. Maximum observed serum concentration(Cmax) [Cycle 1 Day 1 up to 60 days after last dose]

  2. Time of maximum observed serum concentration(Tmax) [Cycle 1 Day 1 up to 60 days after last dose]

  3. 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]

  4. Observed serum concentration at the end of a dosing interval(Ctau) [Cycle 1 Day 1 up to 60 days after last dose]

  5. Area under the concentration-time curve in 1 dosing interval(AUC(TAU)) [Cycle 1 Day 1 up to 60 days after last dose]

  6. Characterization of Immunogenicity [Cycle 1 Day 1 up to 60 days after last dose]

    Anti-Drug Antibodies

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Local InstitutionBarcelonaSpain08035
2Local InstitutionMadridSpain28041
3Local InstitutionMajadahonda - MadridSpain28222
4Local InstitutionMalagaSpain29010

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02815592
Other Study ID Numbers:
  • CA001-044
  • 2016-001692-67
First Posted:
Jun 28, 2016
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021