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TerminatedPhase 3NCT03348904
Official study title

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

Study summary

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Epacadostat

Plus 6 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 13, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Incyte Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Incyte Corporation
Interventions being studied
Drug: Nivolumab; Drug: Epacadostat; Drug: Placebo; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pemetrexed
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→Recurrent or relapsed→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Pacific Cancer Medical Center, IncAnaheim, California
  • Cancer Center of KansasWichita, Kansas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 13, 2019. Always confirm current availability with the study team.

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