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

NCT03348904 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-06-13

Study results available
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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).

Conditions

Interventions

DRUG

Nivolumab

Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.

DRUG

Epacadostat

Epacadostat administered orally at the protocol-defined dose twice daily.

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.

Sponsors & Collaborators

Principal Investigators

  • Sridhar K. Rabindran, PhD · Bristol-Myers Squibb Research and Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-27
Primary Completion
2018-05-22
Completion
2018-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348904 on ClinicalTrials.gov