Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Epacadostat; Placebo; Carboplatin; Cisplatin; Gemcitabine; Paclitaxel; Pemetrexed
Intervention description: Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.; Epacadostat administered orally at the protocol-defined dose twice daily.; Matching placebo for epacadostat administered orally twice daily.; Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine; Nivolumab; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small cell lung cancer; programmed cell death protein 1 (PD-1) antibody; indoleamine 2,3-dioxygenase (IDO) inhibitor

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).
    

Eligibility criteria:

        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.