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

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

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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