Status:
COMPLETED
Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)
Lead Sponsor:
Incyte Corporation
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-sm...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation.
- Measurable disease based on RECIST 1.1.
- Tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥ 50% of tumor cells (tumor proportion score \[TPS\] ≥ 50%) as assessed by immunohistochemistry at a central laboratory.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function per protocol-defined criteria.
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.
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2020
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT03322540
Start Date
December 15 2017
End Date
November 9 2020
Last Update
August 22 2025
Active Locations (101)
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1
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
2
Innovative Clinical Research Institute
Whittier, California, United States, 90603
3
Florida Cancer Specialists (South Region)
Fort Myers, Florida, United States, 33916
4
Florida Cancer Specialists (North Region)
St. Petersburg, Florida, United States, 33705