Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)
| Verified date | December 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).
| Status | Active, not recruiting |
| Enrollment | 436 |
| Est. completion date | July 1, 2026 |
| Est. primary completion date | April 11, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206) | ABB | Caba |
| Argentina | CEMIC ( Site 0201) | Buenos Aires | |
| Argentina | Hospital Aleman ( Site 0200) | Buenos Aires | |
| Argentina | Hospital Britanico de Buenos Aires ( Site 0204) | Buenos Aires | Caba |
| Argentina | IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208) | Buenos Aires | |
| Argentina | Instituto Medico Especializado Alexander Fleming ( Site 0203) | Buenos Aires | |
| Argentina | Hospital Provincial del Centenario ( Site 0205) | Rosario | Santa Fe |
| Argentina | Sanatorio Parque ( Site 0207) | Rosario | Santa Fe |
| Australia | Royal Brisbane and Women s Hospital ( Site 2502) | Herston | Queensland |
| Australia | Icon Cancer Centre Hobart ( Site 2507) | Hobart | Tasmania |
| Australia | Austin Health ( Site 2501) | Melbourne | Victoria |
| Australia | Port Macquarie Base Hospital ( Site 2500) | Port Macquarie | New South Wales |
| Australia | GenesisCare North Shore ( Site 2508) | St Leonards | New South Wales |
| Austria | Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804) | Graz | Steiermark |
| Austria | Universitatsklinik LKH Innsbruck ( Site 0802) | Innsbruck | Tirol |
| Austria | Keppler Universitatsklinikum ( Site 0806) | Linz | Oberosterreich |
| Austria | Social Medical Center - Otto Wagner Hospital ( Site 0801) | Vienna | Wien |
| Brazil | Clínica de Oncologia Reichow ( Site 0319) | Blumenau | Santa Catarina |
| Brazil | Hospital e Maternidade Celso Pierro ( Site 0313) | Campinas | Sao Paulo |
| Brazil | Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305) | Rio de Janeiro | |
| Brazil | A.C. Camargo Cancer Center ( Site 0312) | Sao Paulo | |
| Brazil | Hospital Paulistano - Amil Clinical Research ( Site 0316) | Sao Paulo | |
| Brazil | Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300) | Sao Paulo | |
| Canada | Kingston Health Sciences Centre ( Site 0100) | Kingston | Ontario |
| Canada | Trillium Health Partners - Credit Valley Hospital ( Site 0102) | Mississauga | Ontario |
| Canada | Moncton Hospital - Horizon Health Network ( Site 0105) | Moncton | New Brunswick |
| Canada | CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110) | Montreal | Quebec |
| Canada | McGill University Health Centre ( Site 0113) | Montréal | Quebec |
| Canada | The Ottawa Hospital ( Site 0104) | Ottawa | Ontario |
| Canada | Sault Area Hospital ( Site 0101) | Sault Ste Marie | Ontario |
| Canada | CHUS - Hopital Fleurimont ( Site 0111) | Sherbrooke | Quebec |
| Canada | Health Sciences North Research Institute ( Site 0107) | Sudbury | Ontario |
| France | Hopital Sud du Amiens ( Site 1115) | Amiens | Somme |
| France | Institut Bergonie ( Site 1102) | Bordeaux | Gironde |
| France | CHU de Brest -Site Hopital Morvan ( Site 1100) | Brest | Finistere |
| France | Institut Regional du Cancer de Montpellier - ICM ( Site 1108) | Montpellier | Herault |
| France | A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114) | Paris | |
| France | Hopital Cochin ( Site 1107) | Paris | |
| France | Institut Curie ( Site 1112) | Paris | |
| France | CHU Poitiers ( Site 1109) | Poitiers | Ain |
| France | CHU de Rouen ( Site 1113) | Rouen | Seine-Maritime |
| Germany | Charite Universitaetsmedizin Berlin ( Site 1207) | Berlin | |
| Germany | Universitaetsklinikum Erlangen ( Site 1209) | Erlangen | Bayern |
| Germany | Universitaetsklinikum Essen ( Site 1201) | Essen | Nordrhein-Westfalen |
| Germany | Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208) | Esslingen | Baden-Wurttemberg |
| Germany | UKGM Gießen/Marburg-Medical Clinic V ( Site 1210) | Gießen | Hessen |
| Germany | Evangelisches Krankenhaus Hamm gGmbH ( Site 1205) | Hamm | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Heidelberg. ( Site 1204) | Heidelberg | Baden-Wurttemberg |
| Germany | Pius Hospital Oldenburg ( Site 1202) | Oldenburg | Niedersachsen |
| Hungary | Orszagos Koranyi Pulmonologiai Intezet ( Site 2304) | Budapest | |
| Hungary | Orszagos Koranyi Pulmonologiai Intezet ( Site 2306) | Budapest | |
| Hungary | Orszagos Onkologiai Intezet ( Site 2308) | Budapest | |
| Hungary | Semmelweis University ( Site 2303) | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Kozpont ( Site 2301) | Debrecen | Hajdu-Bihar |
| Hungary | Farkasgyepui Tudogyogyintezet ( Site 2313) | Farkasgyepu | Veszprem |
| Hungary | Petz Aladar Megyei Oktato Korhaz ( Site 2305) | Gyor | Gyor-Moson-Sopron |
| Hungary | Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307) | Kaposvar | Somogy |
| Hungary | Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2311) | Kecskemét | Bacs-Kiskun |
| Hungary | CRU Hungary KFT ( Site 2309) | Miskolc | Borsod-Abauj-Zemplen |
| Hungary | Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314) | Pécs | Baranya |
| Hungary | Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312) | Szekesfehervar | Fejer |
| Hungary | Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2310) | Szolnok | Jasz-Nagykun-Szolnok |
| Hungary | Törökbálinti Tüdogyógyintézet ( Site 2302) | Torokbalint | Pest |
| Italy | Ospedale Santissima Annunziata ( Site 1303) | Chieti | |
| Italy | A.O. Universitaria Careggi ( Site 1301) | Firenze | |
| Italy | Policlinico di Modena ( Site 1306) | Modena | |
| Italy | Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309) | Roma | |
| Italy | Policlinico Agostino Gemelli ( Site 1302) | Roma | |
| Japan | Chiba University Hospital ( Site 2806) | Chiba | |
| Japan | University of Yamanashi Hospital ( Site 2807) | Chuo | Yamanashi |
| Japan | National Hospital Organization Kyushu Cancer Center ( Site 2816) | Fukuoka | |
| Japan | Kansai Medical University Hospital ( Site 2808) | Hirakata | Osaka |
| Japan | Hiroshima University Hospital ( Site 2810) | Hiroshima | |
| Japan | National Cancer Center Hospital East ( Site 2800) | Kashiwa | Chiba |
| Japan | Kobe Minimally Invasive Cancer Center ( Site 2811) | Kobe | Hyogo |
| Japan | Kurume University Hospital ( Site 2815) | Kurume | Fukuoka |
| Japan | Aichi Cancer Center Hospital ( Site 2804) | Nagoya | Aichi |
| Japan | Niigata Cancer Center Hospital ( Site 2801) | Niigata | |
| Japan | Osaka International Cancer Institute ( Site 2812) | Osaka | |
| Japan | Sendai Kousei Hospital ( Site 2814) | Sendai | Miyagi |
| Japan | Osaka Medical and Pharmaceutical University Hospital ( Site 2813) | Takatsuki | Osaka |
| Japan | Showa University Hospital ( Site 2805) | Tokyo | |
| Japan | The Cancer Institute Hospital of JFCR ( Site 2803) | Tokyo | |
| Japan | Tokyo Metropolitan Komagome Hospital ( Site 2802) | Tokyo | |
| Japan | University of Tsukuba Hospital ( Site 2809) | Tsukuba | Ibaraki |
| Korea, Republic of | Chungbuk National University Hospital ( Site 2605) | Cheongju-si | Chungbuk |
| Korea, Republic of | National Cancer Center ( Site 2604) | Goyang-si | Kyonggi-do |
| Korea, Republic of | The Catholic University of Korea St. Vincent s Hospital ( Site 2606) | Gyeonggi-do | Kyonggi-do |
| Korea, Republic of | Samsung Medical Center ( Site 2603) | Seoul | |
| Korea, Republic of | Seoul National University Hospital ( Site 2600) | Seoul | |
| Netherlands | Meander Medisch Centrum-Studie Team Oncologie ( Site 1403) | Amersfoort | Utrecht |
| Netherlands | Ziekenhuis Rijnstate ( Site 1405) | Arnhem | Gelderland |
| Netherlands | Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407) | Hilversum | Noord-Holland |
| New Zealand | Auckland City Hospital ( Site 2900) | Grafton | Auckland |
| Norway | Helse Bergen HF Haukeland Universitetssykehus ( Site 1502) | Bergen | Vestfold |
| Norway | Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500) | Oslo | |
| Norway | St Olavs Hospital ( Site 1504) | Trondheim | Sor-Trondelag |
| Poland | Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403) | Gliwice | Slaskie |
| Poland | Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400) | Krakow | Malopolskie |
| Poland | Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402) | Lodz | Lodzkie |
| Poland | SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404) | Olsztyn | Warminsko-mazurskie |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( | Warszawa | Mazowieckie |
| Romania | Institutul Oncologic-Oncologie Medicala ( Site 3202) | Cluj | |
| Romania | Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201) | Flore?ti | Cluj |
| Russian Federation | Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014) | Chelyabinsk | Chelyabinskaya Oblast |
| Russian Federation | Sverdlovsk Regional Oncology Hospital ( Site 2012) | Ekaterinburg | Sverdlovskaya Oblast |
| Russian Federation | Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001) | Kazan | Tatarstan, Respublika |
| Russian Federation | GUZ Lipetsk Regional Oncology Dispensary ( Site 2010) | Lipetsk | Lipetskaya Oblast |
| Russian Federation | N.N.Blokhin Russian Cancer Research center ( Site 2013) | Moscow | Moskva |
| Russian Federation | Russian Scientific Center of Roentgenoradiology ( Site 2011) | Moscow | Moskva |
| Russian Federation | Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000) | Saint-Petersburg | Sankt-Peterburg |
| Russian Federation | Medical institute named after Berezin Sergey ( Site 2009) | St. Petersburg | Sankt-Peterburg |
| Spain | Hospital General Universitari Vall d Hebron ( Site 1602) | Barcelona | |
| Spain | Hospital General Universitario Gregorio Maranon ( Site 1604) | Madrid | |
| Spain | Hospital Universitario Quiron Madrid ( Site 1601) | Pozuelo de Alarcon | Madrid |
| Spain | Hospital Universitario La Fe ( Site 1603) | Valencia | Valenciana, Comunitat |
| Switzerland | Hopitaux Universitaires de Geneve HUG ( Site 1706) | Geneva | Geneve |
| Switzerland | Universitaetsspital Zuerich ( Site 1700) | Zuerich | Zurich |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3304) | Kaohsiung | |
| Taiwan | Taipei Medical University Hospital ( Site 3303) | Taipei | |
| Taiwan | Taipei Veterans General Hospital ( Site 3301) | Taipei | |
| Taiwan | Tri-Service General Hospital ( Site 3300) | Taipei City | Taipei |
| Turkey | Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105) | Adana | |
| Turkey | Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101) | Ankara | |
| Turkey | Hacettepe University Medical Faculty ( Site 2100) | Ankara | |
| Turkey | Göztepe Prof. Dr. Süleyman Yalçin Sehir Hastanesi-oncology ( Site 2116) | Istanbul | |
| Turkey | Kartal Training and Research Hospital ( Site 2102) | Istanbul | |
| Turkey | I.E.U. Medical Point Hastanesi ( Site 2115) | Izmir | |
| Turkey | Erciyes University Medical Faculty ( Site 2109) | Kayseri | |
| Turkey | Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114) | Sakarya | |
| Ukraine | Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207) | Dnipro | Dnipropetrovska Oblast |
| Ukraine | Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205) | Kapitanivka Village | Kyivska Oblast |
| Ukraine | Regional Centre of Oncology-Thoracic organs ( Site 2202) | Kharkiv | Kharkivska Oblast |
| Ukraine | Medical Center Asklepion LLC ( Site 2208) | Khodosivka | Kyivska Oblast |
| Ukraine | Ukrainian Center of Tomotherapy ( Site 2206) | Kropyvnitskiy | Kirovohradska Oblast |
| Ukraine | Kyiv City Clinical Oncology Centre ( Site 2200) | Kyiv | |
| Ukraine | Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203) | Kyiv | Kyivska Oblast |
| United Kingdom | University Hospitals Bristol NHS Foundation Trust ( Site 1802) | Bristol | Bristol, City Of |
| United Kingdom | Darlington Memorial Hospital NHS Trust ( Site 1810) | Darlington | |
| United Kingdom | Leicester Royal Infirmary ( Site 1811) | Leicester | Leicestershire |
| United Kingdom | Clatterbridge Cancer Center NHS FT ( Site 1800) | Liverpool | England |
| United Kingdom | Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808) | London | London, City Of |
| United Kingdom | Royal Free London NHS Foundation Trust ( Site 1813) | London | Camden |
| United Kingdom | University College London Hospital NHS Foundation Trust ( Site 1806) | London | London, City Of |
| United Kingdom | Mount Vernon Hospital ( Site 1803) | Northwood | |
| United Kingdom | Norfolk and Norwich University Foundation NHS Trust ( Site 1805) | Norwich | Norfolk |
| United Kingdom | Oxford University Hospitals NHS Foundation Trust ( Site 1812) | Oxford | Oxfordshire |
| United Kingdom | Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809) | Preston | Lancashire |
| United Kingdom | Weston Park Hospital ( Site 1801) | Sheffield | Derbyshire |
| United States | Lehigh Valley Hospital- Cedar Crest ( Site 3005) | Allentown | Pennsylvania |
| United States | Alaska Oncology and Hematology ( Site 3063) | Anchorage | Alaska |
| United States | Sinai Hospital of Baltimore ( Site 3011) | Baltimore | Maryland |
| United States | Sanford Bemidji ( Site 0080) | Bemidji | Minnesota |
| United States | St. Luke's University Health Network ( Site 3006) | Bethlehem | Pennsylvania |
| United States | St. Vincent Healthcare Frontier Cancer Center ( Site 3012) | Billings | Montana |
| United States | University of Alabama ( Site 0099) | Birmingham | Alabama |
| United States | Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007) | Boston | Massachusetts |
| United States | University of Missouri Hospital ( Site 3058) | Columbia | Missouri |
| United States | Mass General / North Shore Center for Outpatient Care ( Site 3040) | Danvers | Massachusetts |
| United States | National Jewish Health ( Site 0010) | Denver | Colorado |
| United States | Hematology-Oncology Associates of CNY ( Site 3055) | East Syracuse | New York |
| United States | Sanford Health Roger Maris Cancer Center ( Site 0079) | Fargo | North Dakota |
| United States | Banner MD Anderson Cancer Center ( Site 3029) | Gilbert | Arizona |
| United States | Goshen Center for Cancer Care ( Site 0022) | Goshen | Indiana |
| United States | John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036) | Hackensack | New Jersey |
| United States | Penn State University Milton S. Hershey Medical Center ( Site 0064) | Hershey | Pennsylvania |
| United States | Franciscan Health Indianapolis ( Site 0024) | Indianapolis | Indiana |
| United States | Mountain States Health Alliance ( Site 3054) | Johnson City | Tennessee |
| United States | University of Tennessee Medical Center Knoxville ( Site 3010) | Knoxville | Tennessee |
| United States | University of Kentucky School of Medicine & Hospitals ( Site 0026) | Lexington | Kentucky |
| United States | CARTI Cancer Center ( Site 3045) | Little Rock | Arkansas |
| United States | USC Norris Comprehensive Cancer Center ( Site 0007) | Los Angeles | California |
| United States | University of Minnesota ( Site 0069) | Minneapolis | Minnesota |
| United States | Infirmary Cancer Care ( Site 3044) | Mobile | Alabama |
| United States | Vanderbilt University Medical Center ( Site 0075) | Nashville | Tennessee |
| United States | Rutgers Cancer Institute of New Jersey ( Site 0043) | New Brunswick | New Jersey |
| United States | Yale University ( Site 0011) | New Haven | Connecticut |
| United States | Mount Sinai Hospital ( Site 0046) | New York | New York |
| United States | Mid Florida Hematology and Oncology Center ( Site 0067) | Orange City | Florida |
| United States | Veterans Affairs Palo Alto Health Care System ( Site 3039) | Palo Alto | California |
| United States | Fox Chase Cancer Center ( Site 0051) | Philadelphia | Pennsylvania |
| United States | Allegheny General Hospital ( Site 3028) | Pittsburgh | Pennsylvania |
| United States | Sanford Cancer Center Oncology Clinic ( Site 0053) | Sioux Falls | South Dakota |
| United States | Cancer Care Northwest ( Site 0063) | Spokane Valley | Washington |
| United States | Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060) | Springfield | Missouri |
| United States | H. Lee Moffitt Cancer Center and Research Institute ( Site 0016) | Tampa | Florida |
| United States | Westchester Medical Center ( Site 3057) | Valhalla | New York |
| United States | William E. Kahlert Regional Cancer Center ( Site 3031) | Westminster | Maryland |
| United States | White Plains Hospital ( Site 3014) | White Plains | New York |
| United States | University of Massachusetts ( Site 0029) | Worcester | Massachusetts |
| United States | Lankenau Medical Center ( Site 3041) | Wynnewood | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Austria, Brazil, Canada, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Event-free Survival (EFS) | EFS is defined as the time from randomization to the first occurrence of any of the following events:
Local, regional, or distant recurrence of disease as assessed by: Radiographic recurrence by blinded independent central review (BICR) Positive pathology by local assessment Physical examination by local assessment confirmed by positive pathology and/or radiographic recurrence by BICR OR Death due to any cause. EFS will be presented. |
Up to approximately 68 months | |
| Secondary | Overall Survival (OS) | OS is defined as the time from date of randomization to date of death from any cause. OS will be presented. | Up to approximately 81 months | |
| Secondary | Time to Death or Distant Metastases (TDDM) | TTDM is defined as the time from randomization to the first documented distant metastases or death from any cause, whichever occurs first. The TDDM will be presented. | Up to approximately 81 months | |
| Secondary | Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented. | Up to approximately 16 months | |
| Secondary | Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented. | Up to approximately 1 year | |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. The change from baseline in Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented. | Baseline and up to approximately 52 weeks | |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Cough (Item 31) Score | The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in cough (EORTC QLQ LC13 Item 31) score will be presented. | Baseline and up to approximately 52 weeks | |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Chest Pain (Item 10) Score | The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. | Baseline and up to approximately 52 weeks | |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented. | Baseline and up to approximately 52 weeks | |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented. | Baseline and up to approximately 52 weeks |
| Status | Clinical Trial | Phase | |
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A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
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ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
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| Recruiting |
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Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
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Phase 1 | |
| Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
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Phase 3 | |
| Recruiting |
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Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
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Phase 2 | |
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NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
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Phase 1/Phase 2 | |
| Completed |
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Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
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| Recruiting |
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A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
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Phase 1/Phase 2 | |
| Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
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Phase 2 | |
| Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
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| Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
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Phase 4 | |
| Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
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Phase 1/Phase 2 | |
| Completed |
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A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
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Phase 1/Phase 2 | |
| Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
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Phase 1 | |
| Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
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| Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
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Phase 1 |