Lung Cancer Clinical Trial

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)

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 as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

233

Study ID:

NCT03322566

Recruitment Status:

Completed

Sponsor:

Incyte Corporation

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 94 Locations for this study

See Locations Near You

Southern Cancer Center, PC
Daphne Alabama, 36526, United States
Western Regional Medical Center, Inc.
Goodyear Arizona, 85338, United States
Arizona Oncology Associates PC- HOPE
Tucson Arizona, 85704, United States
Lynn Cancer Institute
Boca Raton Florida, 33486, United States
Florida Cancer Specialists (South Region)
Fort Myers Florida, 33901, United States
Florida Cancer Specialists (North Region)
Saint Petersburg Florida, 33705, United States
PPG-Oncology
Fort Wayne Indiana, 46845, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
MMCORC
Saint Louis Park Minnesota, 55416, United States
St. Vincent Healthcare Frontier Cancer Center
Billings Montana, 59102, United States
New York Oncology Hematology P.C
Albany New York, 12208, United States
Oncology Hematology Care, Inc.
Cincinnati Ohio, 45242, United States
Southwestern Regional Medical Center, Inc.
Tulsa Oklahoma, 74133, United States
St. Luke's Hospital - Anderson Campus
Easton Pennsylvania, 18045, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15224, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
Chattanooga Tennessee, 37404, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Texas Oncology-Denton South
Denton Texas, 76210, United States
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg Virginia, 24060, United States
Emily Couric Clinical Cancer Center
Charlottesville Virginia, 22908, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
MNCCI Port Macquarie Base Hospital
Port Macquarie New South Wales (Australia), 2444, Australia
Blacktown Hospital
Blacktown New South Wales, 2148, Australia
Chris OBrien Lifehouse
Camperdown New South Wales, 2050, Australia
The Crown Princess Mary Cancer Centre Westmead
Westmead New South Wales, 2145, Australia
Southern Medical Day Care Centre
Wollongong New South Wales, 2500, Australia
Cairns Base Hospital
Cairns Queensland, 4870, Australia
BCCA-Cancer Centre of the Southern Interior
Kelowna British Columbia, V1Y 5, Canada
Lions Gate Hospital
North Vancouver British Columbia, V7L 2, Canada
CISSS de la Monteregie-Centre
Greenfield Park Quebec, J4V 2, Canada
CSSS de Laval- Hopital de la Cite de la Sante
Laval Quebec, H7M 3, Canada
CIUSSS Ouest de l'Ile - St-Mary's Hospital
Montréal Quebec, H3T 1, Canada
CIUSSS du Nord-de-l'ILe-de-Montreal Hopital du Sacre-Coeur de Montreal
Montréal Quebec, H4J 1, Canada
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivières Quebec, G8Z 3, Canada
CHU de Quebec - Hotel-Dieu de Quebec
Quebec , G1R 2, Canada
Zala Megyei Korhaz Pozvai Telephely
Pozva Zalaegerszeg, 8900, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest , 1121, Hungary
Veszprem Megyei Tudogyogyintezet
Farkasgyepű , 8582, Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula , 5700, Hungary
CRU Hungary Kft.
Miskolc , 3529, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
Szolnok , 5004, Hungary
St Vincents University Hospital
Dublin , Dubli, Ireland
Ha Emek Medical Center
Afula , 18341, Israel
Soroka Medical Center
Be'er Sheva , 84571, Israel
Rambam Medical Center
Haifa , 35254, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
Rabin Medical Center
Petah Tikva , 52620, Israel
Chaim Sheba Medcal Center
Ramat Gan , 52621, Israel
Centro Di Riferimento Oncologico
Aviano , 33081, Italy
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico
Catania , 95123, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
Istituto Europeo di Oncologia
Milano , 20141, Italy
Ospedale San Gerardo - ASST Monza
Monza , 20900, Italy
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Medical Care Research S.A. de C.V.
Mérida Yucatan, 97070, Mexico
Oaxaca Site Management Organization S.C.
Oaxaca , 68000, Mexico
FAICIC Clinical Research
Veracruz , 91900, Mexico
Belgorod Regional Oncology Dispensary
Belgorod , 30801, Russian Federation
Udmurtia Republic Regional Clinical Oncology Dispensary
Izhevsk , 42606, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH
Kazan , 42002, Russian Federation
Central Clinical Hospital with polyclinic
Moscow , 12135, Russian Federation
Moscow Research Oncology Institute
Moscow , 12528, Russian Federation
SBI of Stavropol region Pyatigorskiy Oncologic dispensary
Pyatigorsk , 35750, Russian Federation
SBHI Leningrad Regional Clinical Hospital
Saint Petersburg , 19429, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary
Samara , 44303, Russian Federation
Oncological Dispensary #2 of Ministry of Health of Krasnodar region
Sochi , 35405, Russian Federation
Tomsk Scientific Research Institute of Oncology
Tomsk , 63402, Russian Federation
Hospital Universitario Insular de Gran Canaria
Las Palmas De Gran Canaria Gran Canaria, 35016, Spain
Hospital Juan Ramón Jimenez
Huelva , 21005, Spain
Institut Catala Oncologia de Bellvitge - ICO
L'Hospitalet De Llobregat , 08980, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario La Fe
Valencia , 46026, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza , 50009, Spain
Chang Gung Medical Foundation, Kaohsiung Branch
Kaohsiung , 833, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
National Cheng Kung University Hospital
Tainan , 70457, Taiwan
National Taiwan University Hospital
Taipei , 10048, Taiwan
Chang Gung Medical Foundation, Linkou Branch
Taoyuan , 33305, Taiwan
Ege Universitesi Tip Fakultesi Hastanesi
Ä°zmir Bornova, 35100, Turkey
Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi
Adana , 01120, Turkey
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi
Adana , 01330, Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara , 06100, Turkey
Uludag Universitesi Tip Fakultesi
Bursa , 16059, Turkey
Pamukkale Unv. Tip Fak
Denizli , 20070, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul , 34098, Turkey
Samsun Medical Park Hastanesi
Samsun , 55200, Turkey
Namık Kemal University Medical Faculty
TekirdaÄŸ , 59030, Turkey
Mount Vernon Cancer Centre
Northwood Middlesex, HA6 2, United Kingdom
Western General Hospital
Edinburgh , EH42X, United Kingdom
North Middlesex Hospital
London , N18 1, United Kingdom
Freeman Hospital Newcastle upon Tyne Foundation NHS Trust
Newcastle Upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

233

Study ID:

NCT03322566

Recruitment Status:

Completed

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider