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Completed

NCT Number: NCT02815592

Trial of BMS-986012 in Combination With Platinum and Etoposide

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0002, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986012

Drug

Cisplatin

Drug

etoposide

Drug

Platinum

Drug

carboplatin

Drug

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Cycle 1, Day 1 up to approximately 26 months.

  2. Number of participants with serious adverse events (SAEs )

    Time frame: Date of enrollment up to approximately 26 months.

  3. Discontinuations due to AEs

    Time frame: Cycle 1, Day 1 up to approximately 26 months.

  4. Number of participants who died due to AEs

    Time frame: Cycle 1, Day 1 up to approximately 26 months.

  5. Number of participants with laboratory toxicity grade shift from baseline

    Time frame: Cycle 1, Day 1 up to approximately 26 months.

  6. Progression Free Survival

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

Secondary outcomes

  1. Maximum observed serum concentration(Cmax)

    Time frame: Cycle 1 Day 1 up to 60 days after last dose

  2. Time of maximum observed serum concentration(Tmax)

    Time frame: 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))

    Time frame: Cycle 1 Day 1 up to 60 days after last dose

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

    Time frame: Cycle 1 Day 1 up to 60 days after last dose

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

    Time frame: Cycle 1 Day 1 up to 60 days after last dose

  6. Characterization of Immunogenicity

    Time frame: Cycle 1 Day 1 up to 60 days after last dose

    Anti-Drug Antibodies

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2024
First posted
Jun 28, 2016
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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