Small Cell Lung Cancer

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

Incyte Study ID:
KEYNOTE-715-06/ECHO-306-06
CT.gov ID:
NCT03322566
View Results Summary
Eudra ID:
2017-001810-27
Sponsor:
Incyte Corporation
Collaborator:
Merck Sharp & Dohme Corp.
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Small Cell Lung Cancer
    • PRODUCT
  • Drug: Pembrolizumab
  • Drug: Epacadostat
  • Drug: Platinum-based chemotherapy
  • Drug: Placebo
    • COLLABORATORS
    Merck Sharp & Dohme Corp.
    DATE
    Jan 2018 - Dec 2018
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Southern Cancer Center, PC
    Daphne, AL, US, 36526
    Name
    Western Regional Medical Center, Inc.
    Goodyear, AZ, US, 85338
    Name
    Arizona Oncology Associates PC- HOPE
    Tucson, AZ, US, 85704
    Name
    University of California San Diego Moores Cancer Center
    La Jolla, California, US, 92093
    Name
    Cedars-Sinai Medical Center
    Los Angeles, CA, US, 90048
    Name
    Kaiser Permanente Northern California Central Office
    Vallejo, CA, US, 94589

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation
    • Measurable disease based on RECIST 1.1

    Exclusion Criteria

    • Known untreated central nervous system metastases and/or carcinomatous meningitis
    • History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.

    Protocol Summary

    Incyte Study ID:
    KEYNOTE-715-06/ECHO-306-06
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    233
    Primary Outcome
    Open

    Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

    Timeframe: Assessed every 12 weeks from the fist dose until the Data Cut Off of 13-Dec 18.

    Secondary Outcome
    Open

    Progression-free survival of Pembrolizumab + Chemotherapy + Epacadostat versus Pembrolizumab + Chemotherapy + Placebo

    Timeframe: Assessed from the start of the study (first dose for that subject) until death or PD, whichever was earlier until the Data Cut Off of 13-Dec 18.

    Overall survival of Pembrolizumab + Chemotherapy + Epacadostat versus Pembrolizumab + Chemotherapy + Placebo

    Timeframe: Assessed from the first dose until the Data Cut Off of 13-Dec 18.

    Duration of response of Pembrolizumab + Chemotherapy + Epacadostat versus Pembrolizumab + Chemotherapy + Placebo

    Timeframe: Assessed from the fist dose until the Data Cut Off of 13-Dec 18.

    Safety and tolerability of Pembrolizumab + Chemotherapy + Epacadostat versus Pembrolizumab + Chemotherapy + Placebo as measured by the number of participants experiencing adverse events (AEs)

    Timeframe: Assessed from the fist dose until the Data Cut Off of 13-Dec 18.

    Safety and tolerability of Pembrolizumab + Chemotherapy + Epacadostat versus Pembrolizumab + Chemotherapy + Placebo as measured by the number of participants discontinuing study drug due to AEs

    Timeframe: Assessed from the fist dose until the Data Cut Off of 13-Dec 18.