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

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Incyte

Status and phase

Terminated
Phase 3

Conditions

Lung Cancer

Treatments

Drug: Nivolumab
Drug: Pemetrexed
Drug: Gemcitabine
Drug: Paclitaxel
Drug: Carboplatin
Drug: Cisplatin
Drug: Placebo
Drug: Epacadostat

Study type

Interventional

Funder types

Industry

Identifiers

NCT03348904
CA2099NC/ECHO-309

Details and patient eligibility

About

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).

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

2 participants in 3 patient groups

Arm A
Experimental group
Description:
Nivolumab plus epacadostat in combination with platinum doublet
Treatment:
Drug: Epacadostat
Drug: Cisplatin
Drug: Carboplatin
Drug: Paclitaxel
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Nivolumab
Arm B
Active Comparator group
Description:
Platinum doublet chemotherapy
Treatment:
Drug: Cisplatin
Drug: Carboplatin
Drug: Paclitaxel
Drug: Gemcitabine
Drug: Pemetrexed
Arm C
Experimental group
Description:
Nivolumab plus placebo in combination with platinum doublet chemotherapy.
Treatment:
Drug: Placebo
Drug: Cisplatin
Drug: Carboplatin
Drug: Paclitaxel
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Nivolumab

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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