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)
12
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4
68.8
3
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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 :
12 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 :
Aug 24, 2022

Arms and Interventions

Arm Intervention/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

Site City State Country Postal Code
1 Local Institution Barcelona Spain 08035
2 Local Institution Madrid Spain 28041
3 Local Institution Majadahonda - Madrid Spain 28222
4 Local Institution Malaga Spain 29010

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:
Apr 28, 2022
Last Verified:
Apr 1, 2022
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 Apr 28, 2022