Lung Cancer Clinical Trial
Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)
Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed 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 pemetrexed plus platinum (carboplatin or cisplatin). 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 pemetrexed. In the Maintenance Phase, participants receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance pemetrexed until progressive disease (PD), intolerable toxicities, or physician decision.
Eligibility Criteria
Inclusion Criteria:
Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
Have stage IV nonsquamous NSCLC.
Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
Have measurable disease based on RECIST 1.1.
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 start the induction phase. 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 life expectancy of at least 3 months.
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 not received prior systemic treatment for their advanced/metastatic NSCLC.
Have 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, and female participants must refrain from donating eggs to others or freeze/store for her own use during the treatment period and for 180 days afterwards.
Exclusion Criteria:
Has predominantly squamous cell 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 (CNS) metastases and/or carcinomatous meningitis.
Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
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.
Has not completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
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There are 176 Locations for this study
Birmingham Alabama, 35205, United States
Muscle Shoals Alabama, 35661, 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, 21239, 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
Knoxville Tennessee, 37920, United States
The Woodlands Texas, 77380, United States
Spokane Valley Washington, 99216, United States
Bahia Blanca Buenos Aires, B8001, Argentina
Buenos Aires Caba, C1280, Argentina
Rio Cuarto Cordoba, X5800, Argentina
Rosario Santa Fe, Rosar, Argentina
San Miguel de Tucuman Tucuman, T4000, Argentina
Buenos Aires , C1199, Argentina
Cordoba , , 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 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
Santa Cruz do Sul Rio Grande Do Sul, 96810, Brazil
Florianopolis Santa Catarina, 88020, Brazil
Itajai Santa Catarina, 88301, Brazil
Joinville Santa Catarina, 89201, 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
North Vancouver British Columbia, V7L 2, Canada
Victoria British Columbia, V8R 6, Canada
Halifax Nova Scotia, B3H 2, Canada
Kitchener Ontario, N2G 1, Canada
Newmarket Ontario, L3Y 2, Canada
Sudbury Ontario, P3E 5, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H3T 1, Canada
Rimouski Quebec, G5L 5, Canada
Sherbrooke Quebec, J1H 5, Canada
Medellin Antioquia, 05003, Colombia
Barranquilla Atlantico, 08002, Colombia
Bogota Distrito Capital De Bogota, 11022, Colombia
Bogota Distrito Capital De Bogota, 11031, Colombia
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, 93053, Germany
Wuerzburg Bayern, 97074, Germany
Frankfurt Hessen, 60590, Germany
Immenhausen Hessen, 34376, Germany
Goettingen Niedersachsen, 37075, Germany
Bonn Nordrhein-Westfalen, 53127, 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
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
Suwon 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 , 08308, Korea, Republic of
Palmerston North Manawatu-Wanganui, 4414, New Zealand
Wellington , 6021, New Zealand
Zgorzelec Dolnoslaskie, 59-90, Poland
Krakow Malopolskie, 31-20, Poland
Warszawa Mazowieckie, 02-78, Poland
Raciborz Slaskie, 47-40, Poland
Olsztyn Warminsko-mazurskie, 10-35, 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
Brasov , 50015, Romania
Bucuresti , 02138, Romania
Constanta , 90059, Romania
Saint Petersburg Leningradskaya Oblast, 19429, Russian Federation
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, 19527, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Pozuelo de Alarcon Madrid, 28223, Spain
Valencia Valenciana, Comunitat, 46010, Spain
Barcelona , 08003, Spain
Sevilla , 41014, Spain
Zaragoza , 50009, Spain
Kaohsiung , 833, 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 , 55280, 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
Kropyvnitskiy Kirovohradska Oblast, 25006, Ukraine
Khodosivka Kyivska Oblast, 08173, Ukraine
Kyiv Kyivska Oblast, 03126, Ukraine
Odesa Odeska Oblast, 65055, Ukraine
Uzhgorod Zakarpatska Oblast, 88000, Ukraine
Kyiv , 03039, Ukraine
Kyiv , 03115, Ukraine
London London, City Of, EC1M , United Kingdom
London London, City Of, SW10 , United Kingdom
Bury Saint Edmunds Suffolk, IP33 , United Kingdom
Colchester Worcestershire, CO4 5, United Kingdom
Birmingham , B9 5S, United Kingdom
Edinburg , EH4 2, United Kingdom
Swansea , SA2 8, United Kingdom
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