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

Part of paid clinical trials in Anaheim, California.

Sponsor
Incyte Corporation
Study ID
NCT03348904
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
  • Epacadostat — DRUG
    Epacadostat administered orally at the protocol-defined dose twice daily.
  • Placebo — DRUG
    Matching placebo for epacadostat administered orally twice daily.
  • Carboplatin — DRUG
    Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
  • Cisplatin — DRUG
    Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
  • Gemcitabine — DRUG
    Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
  • Paclitaxel — DRUG
    Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
  • Pemetrexed — DRUG
    Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.

Study Details

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).

Key Dates

Start date
Dec 27, 2017
Status verified
Jun 2019
Primary completion
May 22, 2018
Completion
May 22, 2018

Study Design

Enrollment
2 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Nivolumab plus epacadostat in combination with platinum doublet
  • Active Comparator: Arm B
    Platinum doublet chemotherapy
  • Experimental: Arm C
    Nivolumab plus placebo in combination with platinum doublet chemotherapy.

Primary Outcome Measure

Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) [ Time Frame: Approximately 38 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Pacific Cancer Medical Center, IncAnaheimCalifornia92801-
Cancer Center of KansasWichitaKansas67214-

Find similar trials in Anaheim, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Pacific Cancer Medical Center, Inc· Anaheim, CACancer Center of Kansas· Wichita, KS

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