KEYNOTE-654-01 / ECHO-305: This Phase III trial is evaluating a immunotherapy drug (Pembrolizumab) alone and in combination with a new oral drug (Epacadostat) for the treatment of metastatic Non-Small Cell (NSC) Lung Cancer with high PD-L1A Phase 3, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Versus Pembrolizumab Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer Expressing High Levels of PD-L1

Exclusion

• Known untreated central nervous system metastases and/or carcinomatous meningitis.
• History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
• Symptomatic ascites or pleural effusion.
• Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
• Active autoimmune disease that has required systemic treatment in past 2 years.
• Has had an allogeneic tissue/solid organ transplant.
• Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
• Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
• History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
• Use of protocol-defined prior/concomitant therapy.