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

June 12, 2019 updated by: Incyte Corporation

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)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Nivolumab plus epacadostat in combination with platinum doublet
Drug: Nivolumab
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
Other Names:
  • BMS-936558
Drug: Epacadostat
Epacadostat administered orally at the protocol-defined dose twice daily.
Other Names:
  • INCB024360
Drug: Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Gemcitabine
Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Paclitaxel
Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Pemetrexed
Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.
Active Comparator: Arm B
Platinum doublet chemotherapy
Drug: Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Gemcitabine
Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Paclitaxel
Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Pemetrexed
Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.
Experimental: Arm C
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
Drug: Nivolumab
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
Other Names:
  • BMS-936558
Drug: Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Gemcitabine
Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Paclitaxel
Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Drug: Pemetrexed
Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.
Drug: Placebo
Matching placebo for epacadostat administered orally twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Time Frame: Approximately 38 months
Defined as the time from randomization to the date of death from any cause.
Approximately 38 months
Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Time Frame: Approximately 25 months
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.
Approximately 25 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Time Frame: Approximately 25 months
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.
Approximately 25 months
Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Time Frame: Approximately 25 months
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.
Approximately 25 months
Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Time Frame: Approximately 38 months
Defined as the time from randomization to the date of death from any cause.
Approximately 38 months
Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Time Frame: Approximately 25 months
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.
Approximately 25 months
Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Time Frame: Approximately 25 months
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.
Approximately 25 months
Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Time Frame: Approximately 25 months
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.
Approximately 25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Sridhar K. Rabindran, PhD, Bristol-Myers Squibb Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2017

Primary Completion (Actual)

May 22, 2018

Study Completion (Actual)

May 22, 2018

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA2099NC/ECHO-309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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