Clinical Trials /

Randomized Phase 2 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-715-05/ECHO-306-05)

NCT03322566

Description:

The purpose of this study is 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).

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

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Pembrolizumab Plus Epacadostat Alone or With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer
  • Official Title: A Randomized Phase 3 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Alone or With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: 715-02/ECHO-306
  • NCT ID: NCT03322566

Conditions

  • Metastatic Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
PembrolizumabMK-3475Arm 1
EpacadostatINCB024360Arm 1
Platinum-based chemotherapyArm 1
PlaceboArm 3

Purpose

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat alone or 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).

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalEpacadostat + pembrolizumab + platinum-based chemotherapy
  • Pembrolizumab
  • Epacadostat
  • Platinum-based chemotherapy
Arm 2ExperimentalEpacadostat + pembrolizumab
  • Pembrolizumab
  • Epacadostat
Arm 3Active ComparatorPlacebo + pembrolizumab + platinum-based chemotherapy
  • Pembrolizumab
  • Platinum-based chemotherapy
  • 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

          -  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.

          -  Provide tumor tissue sample.

        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.

          -  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:Overall survival of epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy
Time Frame:Up to 60 months
Safety Issue:
Description:Defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Measure:Objective response rate of epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy.
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) per RECIST v1.1
Measure:Duration of response of epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy.
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 epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy as measured by the number of participants experiencing adverse events (AEs).
Time Frame:Up to 37 months
Safety Issue:
Description:An 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 epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy as measured by the number of participants discontinuing study drug due to AEs.
Time Frame:Up to 37 months
Safety Issue:
Description:An 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
  • chemotherapy

Last Updated

January 9, 2018