Randomized Phase 2 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-715-05/ECHO-306-05)



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:December 21, 2017
End Date:September 2021

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A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-05/ECHO-306-05)

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus
epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based
chemotherapy plus placebo as first-line therapy in participants with metastatic non-small
cell lung cancer (NSCLC).


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Phone: 727-216-1143
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Phone: 206-288-7445
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Albany, New York 12206
Phone: 281-863-4643
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-647-6883
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Billings, Montana 59102
Phone: 406-238-6290
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2600 Research Center Drive
Blacksburg, Virginia 24060
Phone: 281-863-4643
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Boca Raton, Florida 33486
Phone: 561-955-4800
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Charlottesville, Virginia 22903
Phone: 434-924-4246
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Chattanooga, Tennessee 37404
Phone: 877-691-7274
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Phone: 281-863-4643
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Daphne, Alabama 36526
Phone: 281-863-4643
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Denton, Texas 76210
Phone: 281-863-4643
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Easton, Pennsylvania 18045
Phone: 484-526-6038
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3840 Broadway
Fort Myers, Florida 33901
Phone: 239-274-9930
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11141 Parkview Plaza Drive
Fort Wayne, Indiana 46845
Phone: 260-425-6800
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Goodyear, Arizona 85338
Phone: 623-207-3183
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Nashville, Tennessee 37203
Phone: 615-329-7274
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Phone: 412-578-5393
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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3800 Park Nicollet Boulevard
Saint Louis Park, Minnesota 55416
Phone: 950-993-1555
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Tucson, Arizona 85704
Phone: 281-863-4643
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Tulsa, Oklahoma 74133
Phone: 918-286-5448
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