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

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ClinicalTrials.gov Identifier: NCT03348904
Recruitment Status : Terminated (Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.)
First Posted : November 21, 2017
Results First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Nivolumab Drug: Epacadostat Drug: Placebo Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Drug: Paclitaxel Drug: Pemetrexed Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 27, 2017
Actual Primary Completion Date : May 22, 2018
Actual Study Completion Date : May 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arms and Interventions
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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 Name: BMS-936558

Drug: Epacadostat
Epacadostat administered orally at the protocol-defined dose twice daily.
Other Name: 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 Name: BMS-936558

Drug: Placebo
Matching placebo for epacadostat administered orally twice daily.

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348904


Locations
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United States, California
Pacific Cancer Medical Center, Inc
Anaheim, California, United States, 92801
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
Incyte Corporation
Bristol-Myers Squibb
Investigators
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Study Director: Sridhar K. Rabindran, PhD Bristol-Myers Squibb Research and Development
  Study Documents (Full-Text)

Documents provided by Incyte Corporation:
Study Protocol  [PDF] October 23, 2017
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03348904    
Other Study ID Numbers: CA2099NC/ECHO-309
First Posted: November 21, 2017    Key Record Dates
Results First Posted: June 13, 2019
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Non-small cell lung cancer
programmed cell death protein 1 (PD-1) antibody
indoleamine 2,3-dioxygenase (IDO) inhibitor
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Paclitaxel
Carboplatin
Nivolumab
Pemetrexed
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological