Lung Cancer Clinical Trial
Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)
Summary
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).
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.
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.
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There are 98 Locations for this study
Anaheim California, 92801, United States
Whittier California, 90603, United States
Fort Myers Florida, 33916, United States
Saint Petersburg Florida, 33705, United States
Newnan Georgia, 30265, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21237, United States
Rockville Maryland, 20850, United States
Worcester Massachusetts, 01655, United States
Coon Rapids Minnesota, 55433, United States
Omaha Nebraska, 68130, United States
Pittsburgh Pennsylvania, 15224, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78745, United States
Heidelberg Victoria, 3084, Australia
Murdoch Western Australia, 6150, Australia
Edmonton Alberta, T6G 1, Canada
Moncton New Brunswick, E1C 6, Canada
Brampton Ontario, L6R 3, Canada
Kingston Ontario, K7L 2, Canada
Sault Ste Marie Ontario, P6B 0, Canada
Copenhagen , 2100, Denmark
Herning , 7400, Denmark
Odense , 5000, Denmark
Tartu , 51014, Estonia
Galway Connacht, H91 Y, Ireland
Dublin , Dubli, Ireland
Beer Sheva , 84571, Israel
Haifa , 31096, Israel
Kfar Saba , 44281, Israel
Petah Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Genova , 16132, Italy
Roma , 00168, Italy
Nagoya Aichi, 460-0, Japan
Matsuyama Ehime, 791-0, Japan
Kurume Fukuoka, 830-0, Japan
Kanazawa Ishikawa, 920-8, Japan
Yokohama Kanagawa, 241-8, Japan
Sendai Miyagi, 980-0, Japan
Hirakata Osaka, 573-1, Japan
Osakasayama Osaka, 589-8, Japan
Nagaizumi-chÅ Shizuoka Prefecture, 411-8, Japan
Fukuoka , 811-1, Japan
Fukuoka , 812-8, Japan
Niigata , 951-8, Japan
Okayama , 700-8, Japan
Tokyo , 104-0, Japan
Tokyo , 113-8, Japan
Tokyo , 135-8, Japan
Wakayama , 641-8, Japan
Cheongju si Chungcheongbuk Do, 28644, Korea, Republic of
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Incheon , 21565, Korea, Republic of
Kuantan Pahang, 25100, Malaysia
Putrajaya Wilayah Persekutuan, 62250, Malaysia
Kuala Lumpur , 59100, Malaysia
Kuala Lumpur , , Malaysia
Kuching , , Malaysia
Kielce Swietokrzyskie, 25-73, Poland
Bydgoszcz , 85-79, Poland
Gliwice , 44-10, Poland
Kielce , 25-73, Poland
Konin , 62-50, Poland
Olsztyn , 10-35, Poland
Tarnobrzeg , 39-40, Poland
Warszawa , 02-78, Poland
Belgorod , 30801, Russian Federation
Moscow , 12135, Russian Federation
Moscow , 12528, Russian Federation
Saint Petersburg , 19429, Russian Federation
Samara , 44303, Russian Federation
Ufa , 45005, Russian Federation
Vigo Pontevedra, 36312, Spain
Alicante , 03010, Spain
Barcelona , 8003, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Sevilla , 41009, Spain
Valencia , 46010, Spain
Bellinzona , 6500, Switzerland
Bern , 3010, Switzerland
Geneva , 1211, Switzerland
Winterthur , 8401, Switzerland
Zuerich , 8091, Switzerland
Adana , 01120, Turkey
Ankara , 06100, Turkey
Antalya , 07059, Turkey
Kayseri , 38039, Turkey
Konya , 42080, Turkey
Kryvyi Rih Dnipropetrovsk Region, 50048, Ukraine
Dnipropetrovsk , 49102, Ukraine
Kharkiv , 61024, Ukraine
Kirovohrad , 25001, Ukraine
Kyiv , 03115, Ukraine
Kyiv , 03126, Ukraine
Lutsk , 43018, Ukraine
Odesa , 65055, Ukraine
Zaporizhzhya , 69040, Ukraine
Leeds , LS9 7, United Kingdom
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