NCT03348904

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-27
• Primary completion: 2018-05-22
• Completion: 2018-05-22
• First posted: 2017-11-21
• Last updated: 2019-06-13
• Results posted: 2019-06-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study