Clinical Trials /

Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer

NCT03348904

Description:

The purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC).

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

Terminated

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
  • Official Title: A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

  • ORG STUDY ID: CA2099NC/ECHO-309
  • NCT ID: NCT03348904

Conditions

  • Lung Cancer

Interventions

DrugSynonymsArms
NivolumabBMS-936558Arm A
EpacadostatINCB024360Arm A
PlaceboArm C
CarboplatinArm A
CisplatinArm A
GemcitabineArm A
PaclitaxelArm A
PemetrexedArm A

Purpose

The purpose of this study is to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC).

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalNivolumab plus epacadostat in combination with platinum doublet chemotherapy.
  • Nivolumab
  • Epacadostat
  • Carboplatin
  • Cisplatin
  • Gemcitabine
  • Paclitaxel
  • Pemetrexed
Arm BActive ComparatorPlatinum doublet chemotherapy
  • Carboplatin
  • Cisplatin
  • Gemcitabine
  • Paclitaxel
  • Pemetrexed
Arm CExperimentalNivolumab plus placebo in combination with platinum doublet chemotherapy.
  • Nivolumab
  • Placebo
  • Carboplatin
  • Cisplatin
  • Gemcitabine
  • Paclitaxel
  • Pemetrexed

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous
             histology that is not amenable to therapy with curative intent (surgery or radiation
             therapy with or without chemotherapy).

          -  No prior treatment with systemic anti-cancer therapy for Stage IV disease.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.

          -  Measurable disease by computed tomography or magnetic resonance imaging per RECIST
             v1.1.

          -  Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by
             the central laboratory prior to randomization.

          -  Other protocol inclusion criteria may apply

        Exclusion Criteria:

          -  Known epidermal growth factor receptor (EGFR) mutations sensitive to available
             targeted inhibitor therapy.

          -  Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy.

          -  Untreated central nervous system (CNS) metastases.

          -  Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central
             laboratory.

          -  Carcinomatous meningitis.

          -  Active, known or suspected autoimmune disease.

          -  Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, IDO1
             targeted agent, or any other antibody or drug targeting T cell co-stimulation or
             checkpoint pathways.

          -  History of allergy or hypersensitivity to platinum-containing compounds or study drug
             components.

          -  Physical and laboratory test findings outside the protocol-defined range.

          -  Other protocol exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B)
Time Frame:Approximately 38 months
Safety Issue:
Description:Defined as the time from randomization to the date of death from any cause.

Secondary Outcome Measures

Measure:Objective response rate (ORR) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B)
Time Frame:Approximately 25 months
Safety Issue:
Description:Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review.
Measure:Duration of response (DOR) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B)
Time Frame:Approximately 25 months
Safety Issue:
Description:Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
Measure:Estimate of OS of nivolumab and placebo in combination with chemotherapy (Arm C)
Time Frame:Approximately 38 months
Safety Issue:
Description:Defined as the time from randomization to the date of death from any cause.
Measure:Estimate of PFS of nivolumab and placebo in combination with chemotherapy (Arm C)
Time Frame:Approximately 25 months
Safety Issue:
Description:Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.
Measure:Estimate of ORR of nivolumab and placebo in combination with chemotherapy (Arm C)
Time Frame:Approximately 25 months
Safety Issue:
Description:Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.
Measure:Estimate of DOR of nivolumab and placebo in combination with chemotherapy (Arm C)
Time Frame:Approximately 25 months
Safety Issue:
Description:Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.

Details

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

Trial Keywords

  • Non-small cell lung cancer
  • programmed cell death protein 1 (PD-1) antibody
  • indoleamine 2,3-dioxygenase (IDO) inhibitor

Last Updated

March 22, 2018