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).

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.
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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

154

Study ID:

NCT03322540

Recruitment Status:

Completed

Sponsor:

Incyte Corporation

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There are 98 Locations for this study

See Locations Near You

Pacific Cancer Medical Center, Inc.
Anaheim California, 92801, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
Florida Cancer Specialists (South Region)
Fort Myers Florida, 33916, United States
Florida Cancer Specialists (North Region)
Saint Petersburg Florida, 33705, United States
Southeastern Regional Medical Center, Inc.
Newnan Georgia, 30265, United States
Anne Arundel Health System Research Institute
Annapolis Maryland, 21401, United States
Weinberg Cancer Institute at Franklin Square
Baltimore Maryland, 21237, United States
Maryland Oncology Hematology, P.A.
Rockville Maryland, 20850, United States
UMass Memorial Medical Center
Worcester Massachusetts, 01655, United States
Minnesota Oncology Hematology, PA
Coon Rapids Minnesota, 55433, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, 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-South Austin
Austin Texas, 78745, United States
Austin Health-Austin Hospital
Heidelberg Victoria, 3084, Australia
St John of God Murdoch Medical Clinic
Murdoch Western Australia, 6150, Australia
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Moncton Hospital - Horizon Health Network
Moncton New Brunswick, E1C 6, Canada
William Osler Health System
Brampton Ontario, L6R 3, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston Ontario, K7L 2, Canada
Sault Area Hospital
Sault Ste Marie Ontario, P6B 0, Canada
Rigshospitalet
Copenhagen , 2100, Denmark
Regionshospitalet Herning
Herning , 7400, Denmark
Odense Universitetshospital
Odense , 5000, Denmark
SA Tartu Ulikooli Kliinikum
Tartu , 51014, Estonia
Galway University Hospital
Galway Connacht, H91 Y, Ireland
St Vincents University Hospital
Dublin , Dubli, Ireland
Soroka Medical Center
Beer Sheva , 84571, Israel
Rambam Medical Center
Haifa , 31096, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
Rabin Medical Center
Petah Tikva , 49414, Israel
Chaim Sheba Medical Center
Ramat Gan , 52621, Israel
IRCCS A.O.U. San Martino - IST
Genova , 16132, Italy
Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
National Hospital Organization Nagoya Medical Center
Nagoya Aichi, 460-0, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama Ehime, 791-0, Japan
Kurume University Hospital
Kurume Fukuoka, 830-0, Japan
Kanazawa University Hospital
Kanazawa Ishikawa, 920-8, Japan
Kanagawa Cancer Center
Yokohama Kanagawa, 241-8, Japan
Sendai Kousei Hospital
Sendai Miyagi, 980-0, Japan
Kansai Medical University Hospital
Hirakata Osaka, 573-1, Japan
Kindai University Hospital
Osakasayama Osaka, 589-8, Japan
Shizuoka Cancer Center
Nagaizumi-chō Shizuoka Prefecture, 411-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka , 811-1, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
National Cancer Center Hospital
Tokyo , 104-0, Japan
Nippon Medical School Hospital
Tokyo , 113-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Wakayama Medical University Hospital
Wakayama , 641-8, Japan
Chungbuk National University Hospital
Cheongju si Chungcheongbuk Do, 28644, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Gacheon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Hospital Tengku Ampuan Afzan
Kuantan Pahang, 25100, Malaysia
Institut Kanser Negara - National Cancer Institute
Putrajaya Wilayah Persekutuan, 62250, Malaysia
University Malaya Medical Centre
Kuala Lumpur , 59100, Malaysia
Pantai Hospital Kuala Lumpur
Kuala Lumpur , , Malaysia
Sarawak General Hospital
Kuching , , Malaysia
Swietokrzyskie Centrum Onkologii SPZOZ
Kielce Swietokrzyskie, 25-73, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz , 85-79, Poland
Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie
Gliwice , 44-10, Poland
Swietokrzyskie Centrum Onkologii SPZOZ
Kielce , 25-73, Poland
Przychodnia Lekarska Komed
Konin , 62-50, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn , 10-35, Poland
Wojewodzki Szpital im. Zofii z Zamoyskich Tarnowskiej w Tarnobrzegu
Tarnobrzeg , 39-40, Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warszawa , 02-78, Poland
Belgorod Regional Oncology Dispensary
Belgorod , 30801, Russian Federation
Central Clinical Hospital with polyclinic
Moscow , 12135, Russian Federation
Moscow Research Oncology Institute named after P.A. Hertsen
Moscow , 12528, Russian Federation
SBHI Leningrad Regional Clinical Hospital
Saint Petersburg , 19429, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary
Samara , 44303, Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan
Ufa , 45005, Russian Federation
Hospital Alvaro Cunqueiro
Vigo Pontevedra, 36312, Spain
Hospital General de Alicante
Alicante , 03010, Spain
Hospital del Mar
Barcelona , 8003, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital Clinico de Valencia
Valencia , 46010, Spain
Oncological Institute of Southern Switzerland
Bellinzona , 6500, Switzerland
Inselspital Universitatsspital Bern
Bern , 3010, Switzerland
Hopitaux Universitaires de Geneve HUG.
Geneva , 1211, Switzerland
Kantonsspital Winterthur
Winterthur , 8401, Switzerland
Universitaetsspital Zuerich
Zuerich , 8091, Switzerland
Basken Uni. Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi
Adana , 01120, Turkey
Ankara University Medical Faculty
Ankara , 06100, Turkey
Akdeniz Universitesi Tip Fakultesi
Antalya , 07059, Turkey
Erciyes Universitesi Tip Fakultesi
Kayseri , 38039, Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
Konya , 42080, Turkey
MI Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih Dnipropetrovsk Region, 50048, Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC
Dnipropetrovsk , 49102, Ukraine
Grigoriev Institute for medical Radiology NAMS of Ukraine
Kharkiv , 61024, Ukraine
PP PPC Acinus Medical and Diagnostic Centre
Kirovohrad , 25001, Ukraine
Kyiv City Clinical Oncological Center
Kyiv , 03115, Ukraine
Dobryi Prognoz
Kyiv , 03126, Ukraine
Volyn Regional Oncological Dispensary
Lutsk , 43018, Ukraine
MI Odessa Regional Oncological Centre
Odesa , 65055, Ukraine
Zaporizhzhya Regional Clinical Oncology Center
Zaporizhzhya , 69040, Ukraine
Leeds Teaching Hospital NHS Trust. St. James University Hospital
Leeds , LS9 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

154

Study ID:

NCT03322540

Recruitment Status:

Completed

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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