Lung Cancer Clinical Trial
Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)
Summary
The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).
The primary study hypotheses are:
SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and
SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.
Eligibility Criteria
Inclusion Criteria:
Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded
Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented
Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Is able to receive SBRT and does not have an ultra-centrally located tumor
Has adequate organ function within 7 days prior to the start of study treatment
A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic
Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor
Exclusion Criteria:
Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137])
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast
Has received a live vaccine within 30 days prior to the first dose of study intervention
Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. A prior NSCLC that occurred and was treated curatively at least 2 years prior to the date of the current diagnosis would be considered a separate primary lung cancer, and therefore an additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast c carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has an active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose
Have not adequately recovered from major surgery or have ongoing surgical complications
Has had an allogenic tissue/solid organ transplant
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There are 192 Locations for this study
Birmingham Alabama, 35233, United States
Mobile Alabama, 36607, United States
Anchorage Alaska, 99508, United States
Gilbert Arizona, 85234, United States
Little Rock Arkansas, 72205, United States
Los Angeles California, 90033, United States
Palo Alto California, 94304, United States
Denver Colorado, 80206, United States
New Haven Connecticut, 06510, United States
Orange City Florida, 32763, United States
Tampa Florida, 33612, United States
Goshen Indiana, 46526, United States
Indianapolis Indiana, 46237, United States
Lexington Kentucky, 40536, United States
Baltimore Maryland, 21215, United States
Westminster Maryland, 21157, United States
Boston Massachusetts, 02114, United States
Danvers Massachusetts, 01923, United States
Worcester Massachusetts, 01655, United States
Bemidji Minnesota, 56601, United States
Minneapolis Minnesota, 55455, United States
Columbia Missouri, 65212, United States
Springfield Missouri, 65807, United States
Billings Montana, 59102, United States
Hackensack New Jersey, 07601, United States
New Brunswick New Jersey, 08903, United States
East Syracuse New York, 13057, United States
New York New York, 10029, United States
Valhalla New York, 10595, United States
White Plains New York, 10601, United States
Fargo North Dakota, 58102, United States
Allentown Pennsylvania, 18103, United States
Bethlehem Pennsylvania, 18015, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15212, United States
Wynnewood Pennsylvania, 19096, United States
Sioux Falls South Dakota, 57104, United States
Johnson City Tennessee, 37604, United States
Knoxville Tennessee, 37920, United States
Nashville Tennessee, 37232, United States
Spokane Valley Washington, 99216, United States
ABB Caba, C1199, Argentina
Buenos Aires Caba, C1280, Argentina
Rosario Santa Fe, S2000, Argentina
Rosario Santa Fe, S2002, Argentina
Buenos Aires , 1012, Argentina
Buenos Aires , C1118, Argentina
Buenos Aires , C1426, Argentina
Buenos Aires , C1431, Argentina
Port Macquarie New South Wales, 2444, Australia
St Leonards New South Wales, 2065, Australia
Herston Queensland, 4029, Australia
Hobart Tasmania, 7000, Australia
Melbourne Victoria, 3084, Australia
Linz Oberosterreich, 4021, Austria
Graz Steiermark, 8036, Austria
Innsbruck Tirol, 6020, Austria
Vienna Wien, 1145, Austria
Porto Alegre Rio Grande Do Sul, 90050, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Blumenau Santa Catarina, 89010, Brazil
Campinas Sao Paulo, 13060, Brazil
Rio de Janeiro , 20231, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01321, Brazil
Sao Paulo , 01509, Brazil
Moncton New Brunswick, E1C 6, Canada
Kingston Ontario, K7L 2, Canada
Mississauga Ontario, L5M 2, Canada
Ottawa Ontario, K1H 8, Canada
Sault Ste Marie Ontario, P6B 0, Canada
Sudbury Ontario, P3E 5, Canada
Montreal Quebec, H1T 2, Canada
Montréal Quebec, H4A 3, Canada
Sherbrooke Quebec, J1H 5, Canada
Poitiers Ain, 86021, France
Brest Finistere, 29200, France
Bordeaux Gironde, 33076, France
Montpellier Herault, 34298, France
Rouen Seine-Maritime, 76000, France
Amiens Somme, 80054, France
Paris , 75005, France
Paris , 75014, France
Paris , 75877, France
Esslingen Baden-Wurttemberg, 73730, Germany
Heidelberg Baden-Wurttemberg, 69126, Germany
Erlangen Bayern, 91054, Germany
Gießen Hessen, 35392, Germany
Oldenburg Niedersachsen, 26121, Germany
Essen Nordrhein-Westfalen, 45147, Germany
Hamm Nordrhein-Westfalen, 59063, Germany
Berlin , 13353, Germany
Kecskemét Bacs-Kiskun, 6000, Hungary
Pécs Baranya, 7624, Hungary
Miskolc Borsod-Abauj-Zemplen, 3529, Hungary
Szekesfehervar Fejer, 8000, Hungary
Gyor Gyor-Moson-Sopron, 9024, Hungary
Debrecen Hajdu-Bihar, 4032, Hungary
Szolnok Jasz-Nagykun-Szolnok, 5004, Hungary
Torokbalint Pest, 2045, Hungary
Kaposvar Somogy, 7400, Hungary
Farkasgyepu Veszprem, 8582, Hungary
Budapest , 1085, Hungary
Budapest , 1121, Hungary
Budapest , 1121, Hungary
Budapest , 1122, Hungary
Chieti , 66100, Italy
Firenze , 50134, Italy
Modena , 41124, Italy
Roma , 00168, Italy
Roma , 00185, Italy
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 27785, Japan
Kurume Fukuoka, 830-0, Japan
Kobe Hyogo, 650-0, Japan
Tsukuba Ibaraki, 305-8, Japan
Sendai Miyagi, 980-0, Japan
Hirakata Osaka, 573-1, Japan
Takatsuki Osaka, 56986, Japan
Chuo Yamanashi, 409-3, Japan
Chiba , 260-8, Japan
Fukuoka , 811-1, Japan
Hiroshima , 734-8, Japan
Niigata , 951-8, Japan
Osaka , 541-8, Japan
Tokyo , 113-8, Japan
Tokyo , 135-8, Japan
Tokyo , 142-8, Japan
Cheongju-si Chungbuk, 28644, Korea, Republic of
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Gyeonggi-do Kyonggi-do, 16247, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Arnhem Gelderland, 6815 , Netherlands
Hilversum Noord-Holland, 1213 , Netherlands
Amersfoort Utrecht, 3813 , Netherlands
Grafton Auckland, 1023, New Zealand
Trondheim Sor-Trondelag, 7030, Norway
Bergen Vestfold, 5021, Norway
Oslo , 0450, Norway
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Lodz Lodzkie, 93-51, Poland
Krakow Malopolskie, 31-82, Poland
Warszawa Mazowieckie, 02-78, Poland
Gliwice Slaskie, 44-10, Poland
Olsztyn Warminsko-mazurskie, 10-22, Poland
Florești Cluj, 40728, Romania
Cluj , 40001, Romania
Chelyabinsk Chelyabinskaya Oblast, 45408, Russian Federation
Lipetsk Lipetskaya Oblast, 39800, Russian Federation
Moscow Moskva, 11547, Russian Federation
Moscow Moskva, 11799, Russian Federation
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
St. Petersburg Sankt-Peterburg, 19775, Russian Federation
Ekaterinburg Sverdlovskaya Oblast, 62003, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Pozuelo de Alarcon Madrid, 28223, Spain
Valencia Valenciana, Comunitat, 46206, Spain
Barcelona , 08035, Spain
Madrid , 28009, Spain
Geneva Geneve, 1211, Switzerland
Zuerich Zurich, 8091, Switzerland
Taipei City Taipei, 114, Taiwan
Kaohsiung , 807, Taiwan
Taipei , 11030, Taiwan
Taipei , 11217, Taiwan
Adana , 01250, Turkey
Ankara , 06100, Turkey
Ankara , 06200, Turkey
Istanbul , 34722, Turkey
Istanbul , 34890, Turkey
Izmir , 35520, Turkey
Kayseri , 38030, Turkey
Sakarya , 54290, Turkey
Dnipro Dnipropetrovska Oblast, 49055, Ukraine
Kharkiv Kharkivska Oblast, 61070, Ukraine
Kropyvnitskiy Kirovohradska Oblast, 25011, Ukraine
Kapitanivka Village Kyivska Oblast, 08111, Ukraine
Khodosivka Kyivska Oblast, 08173, Ukraine
Kyiv Kyivska Oblast, 03126, Ukraine
Kyiv , 03115, Ukraine
Bristol Bristol, City Of, BS2 8, United Kingdom
London Camden, NW3 2, United Kingdom
Sheffield Derbyshire, S10 2, United Kingdom
Liverpool England, L7 8Y, United Kingdom
Preston Lancashire, PR2 9, United Kingdom
Leicester Leicestershire, LE1 5, United Kingdom
London London, City Of, NW1 2, United Kingdom
London London, City Of, SE1 9, United Kingdom
Norwich Norfolk, NR47U, United Kingdom
Oxford Oxfordshire, OX3 7, United Kingdom
Darlington , DLX 6, United Kingdom
Northwood , HA6 2, United Kingdom
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