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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)

NCT03322566

Description:

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).

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

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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)
  • Official Title: A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) 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: KEYNOTE-715-06/ECHO-306-06
  • SECONDARY ID: 2017-001810-27
  • NCT ID: NCT03322566

Conditions

  • Lung Cancer

Interventions

DrugSynonymsArms
PembrolizumabMK-3475Pembrolizumab + Chemotherapy + Epacadostat
EpacadostatINCB024360Pembrolizumab + Chemotherapy + Epacadostat
Platinum-based chemotherapyPembrolizumab + Chemotherapy + Epacadostat
PlaceboPembrolizumab + Chemotherapy + Placebo

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).

Trial Arms

NameTypeDescriptionInterventions
Pembrolizumab + Chemotherapy + EpacadostatExperimentalParticipant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
  • Pembrolizumab
  • Epacadostat
  • Platinum-based chemotherapy
Pembrolizumab + Chemotherapy + PlaceboExperimentalParticipant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
  • Pembrolizumab
  • Platinum-based chemotherapy
  • Placebo
Pembrolizumab + EpacadostatExperimentalParticipant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.
  • Pembrolizumab
  • Epacadostat

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:Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Time Frame:Assessed after a minimum of 12 weeks of follow-up ( Data Cut Off of 13-Dec 18).
Safety Issue:
Description:ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).

Secondary Outcome Measures

Measure:Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Time Frame:Assessed from the start of the study until death or PD, whichever was earlier until the Data Cut Off of 13-Dec 18.
Safety Issue:
Description:Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.
Measure:Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Time Frame:Assessed from the start of study until the Data Cut Off of 13-Dec 18.
Safety Issue:
Description:Defined as the time from randomization to death due to any cause.
Measure:Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Time Frame:Assessed from the fist dose until the Data Cut Off of 13-Dec 18.
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 + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)
Time Frame:Assessed from the fist dose until the Data Cut Off of 13-Dec 18.
Safety Issue:
Description:An AE is defined as any untoward medical occurrence in a participant 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 + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
Time Frame:Assessed from the fist dose until the Data Cut Off of 13-Dec 18.
Safety Issue:
Description:An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
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 6, 2021