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).
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.
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There are 94 Locations for this study
Daphne Alabama, 36526, United States
Goodyear Arizona, 85338, United States
Tucson Arizona, 85704, United States
Boca Raton Florida, 33486, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33705, United States
Fort Wayne Indiana, 46845, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Park Minnesota, 55416, United States
Billings Montana, 59102, United States
Albany New York, 12208, United States
Cincinnati Ohio, 45242, United States
Tulsa Oklahoma, 74133, United States
Easton Pennsylvania, 18045, United States
Pittsburgh Pennsylvania, 15224, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Denton Texas, 76210, United States
Blacksburg Virginia, 24060, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98109, United States
Port Macquarie New South Wales (Australia), 2444, Australia
Blacktown New South Wales, 2148, Australia
Camperdown New South Wales, 2050, Australia
Westmead New South Wales, 2145, Australia
Wollongong New South Wales, 2500, Australia
Cairns Queensland, 4870, Australia
Kelowna British Columbia, V1Y 5, Canada
North Vancouver British Columbia, V7L 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Laval Quebec, H7M 3, Canada
Montréal Quebec, H3T 1, Canada
Montréal Quebec, H4J 1, Canada
Trois-Rivières Quebec, G8Z 3, Canada
Quebec , G1R 2, Canada
Pozva Zalaegerszeg, 8900, Hungary
Budapest , 1121, Hungary
Farkasgyepű , 8582, Hungary
Gyula , 5700, Hungary
Miskolc , 3529, Hungary
Szolnok , 5004, Hungary
Dublin , Dubli, Ireland
Afula , 18341, Israel
Be'er Sheva , 84571, Israel
Haifa , 35254, Israel
Kfar Saba , 44281, Israel
Petah Tikva , 52620, Israel
Ramat Gan , 52621, Israel
Aviano , 33081, Italy
Catania , 95123, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Monza , 20900, Italy
Goyang-si , 10408, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Mérida Yucatan, 97070, Mexico
Oaxaca , 68000, Mexico
Veracruz , 91900, Mexico
Belgorod , 30801, Russian Federation
Izhevsk , 42606, Russian Federation
Kazan , 42002, Russian Federation
Moscow , 12135, Russian Federation
Moscow , 12528, Russian Federation
Pyatigorsk , 35750, Russian Federation
Saint Petersburg , 19429, Russian Federation
Samara , 44303, Russian Federation
Sochi , 35405, Russian Federation
Tomsk , 63402, Russian Federation
Las Palmas De Gran Canaria Gran Canaria, 35016, Spain
Huelva , 21005, Spain
L'Hospitalet De Llobregat , 08980, Spain
Madrid , 28046, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Kaohsiung , 833, Taiwan
Taichung , 40447, Taiwan
Tainan , 70457, Taiwan
Taipei , 10048, Taiwan
Taoyuan , 33305, Taiwan
Ä°zmir Bornova, 35100, Turkey
Adana , 01120, Turkey
Adana , 01330, Turkey
Ankara , 06100, Turkey
Bursa , 16059, Turkey
Denizli , 20070, Turkey
Istanbul , 34098, Turkey
Samsun , 55200, Turkey
TekirdaÄŸ , 59030, Turkey
Northwood Middlesex, HA6 2, United Kingdom
Edinburgh , EH42X, United Kingdom
London , N18 1, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
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