Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 20.0 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed stage IV or recurrent NSCLC per the 8th International Association for the Study of Lung Cancer (IASLC) of squamous or non-squamous histology • No prior systemic therapy (including targeted therapy for EGFR and ALK/ROS1) given as primary therapy for advanced disease • Participants with tumors not expressing PD-L1 or expressing PD-L1 at levels between 1 and 49% assessed using validated test at central laboratory in fresh or recent archival tissue obtained no greater than 3 months prior to study enrollment • ECOG Performance Status of = 1 • Measurable disease by CT or MRI per RECIST 1.1 criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 450
Exclusion criteria
Exclusion criteria: • Participants with known EGFR mutations, ALK translocations, or ROS1 rearrangements, which are sensitive to available targeted inhibitor therapy • Participants with interstitial lung disease or active, non-infectious pneumonitis including symptomatic and/or requiring treatment • Unevaluable PD-L1status or PD-L1 status of ? 50% by a central laboratory • Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, or hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment are permitted to enroll. • Participants with untreated CNS metastases. Participants are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare overall survival (OS) and progression-free survival (PFS) per blinded independent central review (BICR) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) to chemotherapy (Arm B) in treatment naïve, Stage 4 or recurrent NSCLC participants whose tumors express PD-L1 at 0 to 49%.;Secondary Objective: • To compare objective response rate (ORR) and to estimate of duration of response (DOR) as assessed by BICR of nivolumab plus epacadostat in combination with chemotherapy (Arm A) to chemotherapy (Arm B) in treatment naïve, Stage 4 or recurrent NSCLC participants whose tumors express PD-L1 at 0 to 49%. • To estimate OS, and PFS, ORR, and DOR per BICR assessment, of nivolumab and placebo for epacadostat in combination with chemotherapy (Arm C) in treatment naïve, Stage 4 or recurrent NSCLC participants whose tumors express PD-L1 at 0 to 49%.;Primary end point(s): • OS • PFS assessed by BICR;Timepoint(s) of evaluation of this end point: At various timepoints detailed in the protocol until the conclusion of the study. Please refer to the Schedule of Activities in Section 2 of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • OS • PFS, ORR and DOR per BICR assessment;Timepoint(s) of evaluation of this end point: At various timepoints detailed in the protocol until the conclusion of the study. Please refer to the Schedule of Activities in Section 2 of the protocol. | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
Incyte Corporation
Outcome results
None listed