NCT02815592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2016

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

November 28, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

June 24, 2016

Last Update Submit

August 30, 2024

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (6)

  • Number of participants with adverse events (AEs)

    Cycle 1, Day 1 up to approximately 26 months.

  • Number of participants with serious adverse events (SAEs )

    Date of enrollment up to approximately 26 months.

  • Discontinuations due to AEs

    Cycle 1, Day 1 up to approximately 26 months.

  • Number of participants who died due to AEs

    Cycle 1, Day 1 up to approximately 26 months.

  • Number of participants with laboratory toxicity grade shift from baseline

    Cycle 1, Day 1 up to approximately 26 months.

  • Progression Free Survival

    From date of first dose or randomization until date of confirmed disease progression, up to 2 years

Secondary Outcomes (6)

  • Maximum observed serum concentration(Cmax)

    Cycle 1 Day 1 up to 60 days after last dose

  • Time of maximum observed serum concentration(Tmax)

    Cycle 1 Day 1 up to 60 days after last dose

  • 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

  • Observed serum concentration at the end of a dosing interval(Ctau)

    Cycle 1 Day 1 up to 60 days after last dose

  • Area under the concentration-time curve in 1 dosing interval(AUC(TAU))

    Cycle 1 Day 1 up to 60 days after last dose

  • +1 more secondary outcomes

Study Arms (4)

Experimental Arm 1

EXPERIMENTAL

BMS-986012/Cisplatin/Etoposide

Drug: BMS-986012Drug: CisplatinDrug: Etoposide

Experimental Arm 2

EXPERIMENTAL

BMS-986012/Carboplatin/Etoposide

Drug: BMS-986012Drug: EtoposideDrug: Carboplatin

Experimental Arm 3A

EXPERIMENTAL

BMS-986012/Platinum/Etoposide

Drug: BMS-986012Drug: EtoposideDrug: Platinum

Active Comparator Arm 3B

ACTIVE COMPARATOR

Platinum/Etoposide

Drug: EtoposideDrug: Platinum

Interventions

BMS-986012DRUG
Experimental Arm 1Experimental Arm 2Experimental Arm 3A
CisplatinDRUG
Experimental Arm 1
EtoposideDRUG
Active Comparator Arm 3BExperimental Arm 1Experimental Arm 2Experimental Arm 3A
PlatinumDRUG
Active Comparator Arm 3BExperimental Arm 3A
CarboplatinDRUG
Experimental Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Local Institution - 0002

Barcelona, 08035, Spain

Location

Local Institution - 0004

Madrid, 28041, Spain

Location

Local Institution - 0003

Majadahonda - Madrid, 28222, Spain

Location

Local Institution - 0010

Málaga, 29010, Spain

Location

Related Links

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

CisplatinEtoposidePlatinumCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesMetals, HeavyElementsTransition ElementsMetalsCoordination Complexes

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 28, 2016

Study Start

November 28, 2016

Primary Completion

December 15, 2019

Study Completion

August 6, 2024

Last Updated

September 4, 2024

Record last verified: 2024-08

Locations

ES(4)