Lung Cancer Clinical Trial
A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:
Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).
Full Description
This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance olaparib placebo. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance olaparib placebo until centrally verified progressive disease (PD), intolerable toxicities, or physician decision."
Eligibility Criteria
Inclusion Criteria:
Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
Have Stage IV squamous NSCLC.
Have measurable disease based on RECIST 1.1.
Have not received prior systemic treatment for their advanced/metastatic NSCLC.
Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
Have a life expectancy of at least 3 months.
Has adequate organ function.
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.
Exclusion Criteria:
Has non-squamous histology NSCLC.
Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
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There are 176 Locations for this study
Birmingham Alabama, 35205, United States
Burbank California, 91505, United States
Boca Raton Florida, 33486, United States
Orange City Florida, 32763, United States
Tampa Florida, 33612, United States
Columbus Georgia, 31904, United States
Chicago Illinois, 60608, United States
Rolling Meadows Illinois, 60008, United States
Merrillville Indiana, 46410, United States
Baltimore Maryland, 21237, United States
Detroit Michigan, 48201, United States
Hattiesburg Mississippi, 39401, United States
Billings Montana, 59102, United States
Bozeman Montana, 59715, United States
Cary North Carolina, 27518, United States
Knoxville Tennessee, 37804, United States
The Woodlands Texas, 77380, United States
Spokane Valley Washington, 99216, United States
Bahia Blanca Buenos Aires, B8001, Argentina
Mar del Plata Buenos Aires, B7600, Argentina
Buenos Aires Caba, C1280, Argentina
Rio Cuarto Cordoba, X5800, Argentina
Rosario Santa Fe, S2000, Argentina
Rosario Santa Fe, S2000, Argentina
San Miguel de Tucuman Tucuman, T4000, Argentina
Buenos Aires , C1199, Argentina
Cordoba , X5004, Argentina
Santa Fe , S3000, Argentina
Liverpool New South Wales, 2170, Australia
Wollongong New South Wales, 2500, Australia
Townsville Queensland, 4814, Australia
Clayton Victoria, 3168, Australia
Linz Oberosterreich, 4020, Austria
Wels Oberosterreich, 4600, Austria
Innsbruck Tirol, 6020, Austria
Vienna Wien, 1145, Austria
Wien , 1210, Austria
Salvador - BA Bahia, 41253, Brazil
Fortaleza Ceara, 60430, Brazil
Belem Para, 66053, Brazil
Bento Goncalves Rio Grande Do Sul, 95700, Brazil
Porto Alegre Rio Grande Do Sul, 90050, Brazil
Itajai Santa Catarina, 88301, Brazil
Sao Jose Rio Preto Sao Paulo, 15090, Brazil
Rio de Janeiro , 20230, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01321, Brazil
Sao Paulo , 01321, Brazil
Halifax Nova Scotia, B3H 1, Canada
Hamilton Ontario, L8V5C, Canada
Kingston Ontario, K7L 2, Canada
Newmarket Ontario, L3Y 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Laval Quebec, H7M 3, Canada
Montreal Quebec, H3T 1, Canada
Trois-Rivieres Quebec, G8Z 3, Canada
Chauny Aisne, 02300, France
Caen Calvados, 14033, France
Angers Maine-et-Loire, 49100, France
Vandoeuvre les Nancy Meurthe-et-Moselle, 54519, France
Vantoux Moselle, 57070, France
Clermont Ferrand Puy-de-Dome, 63011, France
Pau Pyrenees-Atlantiques, 64000, France
Rouen Seine-Maritime, 76000, France
Saint-Mande Val-de-Marne, 94163, France
Aschaffenburg Bayern, 63739, Germany
Muenchen Bayern, 81925, Germany
Munich Bayern, 80336, Germany
Regensburg Bayern, 93042, Germany
Wuerzburg Bayern, 97074, Germany
Frankfurt Hessen, 60590, Germany
Immenhausen Hessen, 34376, Germany
Goettingen Niedersachsen, 37075, Germany
Bonn Nordrhein-Westfalen, 53105, Germany
Essen Nordrhein-Westfalen, 45136, Germany
Koblenz Rheinland-Pfalz, 56068, Germany
Erfurt Thuringen, 99089, Germany
Hamburg , 22087, Germany
Nagoya Aichi, 460-0, Japan
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 277-8, 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
Sakai Osaka, 591-8, Japan
Sunto-gun Shizuoka, 411-8, Japan
Fukuoka , 810-8, Japan
Niigata , 951-8, Japan
Okayama , 700-8, Japan
Osaka , 541-8, Japan
Tokyo , 135-8, Japan
Cheongju si Chungbuk, 28644, Korea, Republic of
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Gyeonggi-do Kyonggi-do, 16247, Korea, Republic of
Suwon Kyonggi-do, 16499, Korea, Republic of
Jinju Kyongsangnam-do, 52727, Korea, Republic of
Songpa-gu Seoul, 05505, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 08308, Korea, Republic of
La Paz Baja California Sur, 23040, Mexico
Guadalajara Jalisco, 44280, Mexico
Monterrey Nuevo Leon, 64060, Mexico
Orizaba Veracruz, 94300, Mexico
Cdmx , 06700, Mexico
Veracruz , 91900, Mexico
Palmerston North Manawatu-Wanganui, 4414, New Zealand
Wellington , 6021, New Zealand
Olsztyn Dolnoslaskie, 10-35, Poland
Zgorzelec Dolnoslaskie, 59-90, Poland
Krakow Malopolskie, 31-20, Poland
Warszawa Mazowieckie, 02-78, Poland
Raciborz Slaskie, 47-40, Poland
Konin Wielkopolskie, 62-50, Poland
Poznan Wielkopolskie, 60-69, Poland
Cluj Napoca Cluj, 40001, Romania
Cluj-Napoca Cluj, 40728, Romania
Craiova Dolj, 20034, Romania
Timisoara Timis, 30023, Romania
Bucuresti , 02254, Romania
Constanta , 90059, Romania
Balashikha Moskovskaya Oblast, 14390, Russian Federation
Moscow Moskva, 11547, Russian Federation
Moscow Moskva, 11999, Russian Federation
Moscow Moskva, 12528, Russian Federation
Moscow Moskva, 12536, Russian Federation
Nizhniy Novgorod Nizhegorodskaya Oblast, 60308, Russian Federation
Omsk Omskaya Oblast, 64401, Russian Federation
Samara Samarskaya Oblast, 44303, Russian Federation
Saint Petersburg Sankt-Peterburg, 19429, Russian Federation
Saint Petersburg Sankt-Peterburg, 19527, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Hospitalet de Llobregat Barcelona, 08908, Spain
Jaen La Coruna, 23007, Spain
Barcelona , 08041, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Sevilla , 41009, Spain
Kaohsiung , 83301, Taiwan
Taichung , 40447, Taiwan
Tainan , 704, Taiwan
Taipei , 10048, Taiwan
Taipei , 104, Taiwan
Taoyuan , 333, Taiwan
Tekirdag Tekirdas, 59100, Turkey
Adana , 01120, Turkey
Ankara , 06500, Turkey
Ankara , 06800, Turkey
Istanbul , 34093, Turkey
Istanbul , 34722, Turkey
Izmir , 35040, Turkey
Kayseri , 38039, Turkey
Samsun , 55270, Turkey
Cherkasy Cherkaska Oblast, 18009, Ukraine
Dnipro Dnipropetrovska Oblast, 49102, Ukraine
Ivano-Frankivsk Ivano-Frankivska Oblast, 76018, Ukraine
Kharkiv Kharkivska Oblast, 61024, Ukraine
Kharkiv Kharkivska Oblast, 61070, Ukraine
Kropyvnytskyi Kirovohradska Oblast, 25006, Ukraine
Khodosivka Kyivska Oblast, 08173, Ukraine
Kyiv Kyivska Oblast, 03115, Ukraine
Kyiv Kyivska Oblast, 03126, Ukraine
Odesa Odeska Oblast, 65055, Ukraine
Uzhgorod Zakarpatska Oblast, 88000, Ukraine
Kyiv , 03039, Ukraine
Westcliff-on-Sea Essex, SS0 0, United Kingdom
London London, City Of, EC1M , United Kingdom
London London, City Of, SW10 , United Kingdom
Newcastle-upon-Tyne Newcastle Upon Tyne, NE7 7, United Kingdom
Bury Saint Edmunds Suffolk, IP33 , United Kingdom
Swansea Wales, SA2 8, United Kingdom
Colchester Worcestershire, CO4 5, United Kingdom
Birmingham , B9 5S, United Kingdom
Edinburg , EH4 2, United Kingdom
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