Status:
COMPLETED
A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)
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 was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo ...
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
- 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.
- Provide tumor tissue sample.
Exclusion
- Known untreated central nervous system metastases and/or carcinomatous meningitis
- History of (non-infectious) 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 :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2020
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT03322566
Start Date
January 9 2018
End Date
October 16 2020
Last Update
January 24 2022
Active Locations (94)
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1
Southern Cancer Center, PC
Daphne, Alabama, United States, 36526
2
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States, 85338
3
Arizona Oncology Associates PC- HOPE
Tucson, Arizona, United States, 85704
4
Lynn Cancer Institute
Boca Raton, Florida, United States, 33486