Clinical Trials /

Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-04/ECHO-305-04)

NCT03322540

Description:

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer
  • Official Title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Versus Pembrolizumab Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer Expressing High Levels of PD-L1

Clinical Trial IDs

  • ORG STUDY ID: 654-01/ECHO-305
  • NCT ID: NCT03322540

Conditions

  • Metastatic Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
PembrolizumabMK-3475Treatment 1
EpacadostatINCB024360Treatment 1
PlaceboTreatment 2

Purpose

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).

Trial Arms

NameTypeDescriptionInterventions
Treatment 1ExperimentalPembrolizumab + epacadostat
  • Pembrolizumab
  • Epacadostat
Treatment 2Active ComparatorPembrolizumab + matching placebo
  • Pembrolizumab
  • Placebo

Eligibility 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.

          -  Tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥
             50% of tumor cells (tumor proportion score [TPS] ≥ 50%) as assessed by
             immunohistochemistry at a central laboratory.

          -  Life expectancy of at least 3 months.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Adequate organ function per protocol-defined criteria.

        Exclusion Criteria:

          -  Known untreated central nervous system metastases and/or carcinomatous meningitis.

          -  History of (noninfectious) pneumonitis that required systemic steroids or current
             pneumonitis/interstitial lung disease.

          -  Symptomatic ascites or pleural effusion.

          -  Known history of an additional malignancy, except if the participant has undergone
             potentially curative therapy with no evidence of that disease recurrence for 5 years
             since initiation of that therapy.

          -  Active autoimmune disease that has required systemic treatment in past 2 years.

          -  Has had an allogeneic tissue/solid organ transplant.

          -  Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is
             not required unless mandated by the local health authority.

          -  Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has
             active Hepatitis C (HCV RNA). Note: Testing must be performed to determine
             eligibility.

          -  History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's
             opinion, is clinically meaningful.

          -  Use of protocol-defined prior/concomitant therapy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS) of pembrolizumab + epacadostat versus pembrolizumab + placebo
Time Frame:Approximately 24 months
Safety Issue:
Description:Defined as the time from randomization to the first documented progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Measure:Objective response rate of pembrolizumab + epacadostat versus pembrolizumab + placebo
Time Frame:Approximately 24 months
Safety Issue:
Description:Defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) perRECIST v1.1.
Measure:Duration of response of pembrolizumab + epacadostat versus pembrolizumab + placebo
Time Frame:Approximately 24 months
Safety Issue:
Description:Defined as the time from the earliest date of qualifying response until earliest date of disease progression per RECIST v1.1 or death from any cause, whichever comes first.
Measure:Safety and tolerability of pembrolizumab + epacadostat and pembrolizumab + placebo as measured by number of participants experiencing adverse events (AEs)
Time Frame:Up to 37 months
Safety Issue:
Description:AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measure:Safety and tolerability of pembrolizumab + epacadostat and pembrolizumab + placebo as measured by number of participants discontinuing study drug due to AEs
Time Frame:Up to 37 months
Safety Issue:
Description:AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • non-small cell lung cancer
  • programmed cell death 1 (PD-1) inhibitor
  • indoleamine 2
  • 3-dioxygenase 1 (IDO1) inhibitor

Last Updated

January 4, 2018