Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-04/ECHO-305-04)



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:November 22, 2017
End Date:September 2021

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A Phase 2, 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

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-small cell lung cancer (NSCLC) expressing high levels of programmed cell
death ligand 1 (PD-L1).


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.

- 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 Criteria:

- 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.
We found this trial at
25
sites
145 Studley Road
Heidelberg, Victoria 3084
Phone: +61394965000
9070
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Heidelberg,
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Anaheim, California 92801
Phone: 714-999-1465
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Anaheim, CA
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Annapolis, Maryland 21401
Phone: 443-481-4390
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Annapolis, MD
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Phone: 404-778-4995
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
803
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Atlanta, GA
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Austin, Texas 78745
Phone: 281-863-4668
517
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Austin, TX
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Baltimore, Maryland 21237
Phone: 443-777-7364
1154
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Baltimore, MD
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Chattanooga, Tennessee 37404
Phone: 877-691-7274
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Chattanooga, TN
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Cleveland, Ohio 44012
Phone: 216-286-6741
895
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Cleveland, OH
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Coon Rapids, Minnesota 55433
Phone: 281-863-4668
562
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Coon Rapids, MN
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Phone: 281-863-4668
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
1114
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Fairfax, VA
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3840 Broadway
Fort Myers, Florida 33901
Phone: 239-274-9930
1206
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Fort Myers, FL
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11141 Parkview Plaza Drive
Fort Wayne, Indiana 46845
Phone: 260-425-6800
718
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Fort Wayne, IN
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Phone: 551-996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
1285
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Nashville, Tennessee 37203
Phone: 615-329-7274
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New York, New York 10065
Phone: 646-962-2066
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New York, NY
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Newnan, Georgia 30265
Phone: 770-400-6036
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Newnan, GA
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Niles, Illinois 60714
Phone: 281-863-4668
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Niles, IL
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Omaha, Nebraska 68114
Phone: 402-334-4773
260
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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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Rockville, Maryland 20850
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Phone: 727-216-1143
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Seattle, Washington 98104
Phone: 206-215-3086
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Whittier, California 90603
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Worcester, Massachusetts 01605
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Zion, Illinois 60099
Phone: 847-872-4019
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Zion, IL
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