Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)
| Verified date | November 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).
| Status | Active, not recruiting |
| Enrollment | 797 |
| Est. completion date | June 29, 2026 |
| Est. primary completion date | July 10, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC. - If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention. - If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. - Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing. - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization. - Have adequate organ function. Exclusion Criteria: - Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor. - Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids. - Has an active infection requiring systemic therapy. - Has had an allogenic tissue/sold organ transplant. - Has a known severe hypersensitivity (= Grade 3) to pembrolizumab, its active substance and/or any of its excipients. - Has a known severe hypersensitivity (= Grade 3) to any of the study chemotherapy agents and/or to any of their excipients. - Has an active autoimmune disease that has required systemic treatment in past 2 years. - Has a known history of human immunodeficiency virus (HIV) infection. - Has a known history of Hepatitis B or Hepatitis C. - Has a known history of active tuberculosis. - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate. - Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial. - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor. - Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation. - Has received prior radiotherapy within 2 weeks of start of trial treatment. - Has received a live vaccine within 30 days prior to the first dose of trial drug. - Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment. - Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug. - Has a known additional malignancy that is progressing or requires active treatment within the past 5 years. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136) | Berazategui | Buenos Aires |
| Argentina | Fundacion Favaloro ( Site 0128) | Ciudad de Buenos Aires | Caba |
| Argentina | Hospital Privado Universitario de Córdoba ( Site 0139) | Cordoba | |
| Argentina | Sanatorio Allende ( Site 0129) | Cordoba | |
| Argentina | Hospital Privado de Comunidad. ( Site 0130) | Mar del Plata | Buenos Aires |
| Argentina | Hospital Universitario Austral ( Site 0127) | Pilar | Buenos Aires |
| Argentina | Hospital Provincial del Centenario ( Site 0131) | Rosario | Santa Fe |
| Argentina | Sanatorio Britanico ( Site 0125) | Rosario | Santa Fe |
| Argentina | Sanatorio Parque ( Site 0135) | Rosario | Santa Fe |
| Argentina | CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133) | San Juan | |
| Australia | Orange Health Services ( Site 0624) | Orange | New South Wales |
| Australia | Westmead Hospital ( Site 0621) | Westmead | New South Wales |
| Belgium | UZ Gent ( Site 0224) | Gent | Oost-Vlaanderen |
| Belgium | UZ Leuven ( Site 0221) | Leuven | Vlaams-Brabant |
| Belgium | Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223) | Liège | Liege |
| Belgium | AZ Sint-Maarten ( Site 0226) | Mechelen | Antwerpen |
| Belgium | AZ Delta ( Site 0222) | Roeselare | West-Vlaanderen |
| Belgium | AZ Nikolaas ( Site 0225) | Sint-Niklaas | Oost-Vlaanderen |
| Brazil | Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144) | Barretos | Sao Paulo |
| Brazil | Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159) | Brasilia | Distrito Federal |
| Brazil | YNOVA Pesquisa Clinica ( Site 0823) | Florianopolis | Santa Catarina |
| Brazil | Centro Regional Integrado de Oncologia ( Site 0160) | Fortaleza | Ceara |
| Brazil | Instituto do Cancer do Ceara ( Site 0152) | Fortaleza | Ceara |
| Brazil | Hospital de Caridade de Ijui ( Site 0153) | Ijui | Rio Grande Do Sul |
| Brazil | Liga Norte Riograndense Contra o Cancer ( Site 0150) | Natal | Rio Grande Do Norte |
| Brazil | Hospital Nossa Senhora da Conceicao ( Site 0145) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149) | Rio de Janeiro | |
| Brazil | Hospital Alemao Oswaldo Cruz ( Site 0158) | Sao Paulo | |
| Brazil | Hospital Paulistano - Amil Clinical Research ( Site 0822) | Sao Paulo | |
| Canada | CIUSSS du Saguenay-Lac-St-Jean ( Site 0101) | Chicoutimi | Quebec |
| Canada | Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110) | Montreal | Quebec |
| Canada | CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104) | Montreal | Quebec |
| Canada | McGill University Health Centre ( Site 0111) | Montreal | Quebec |
| Canada | Princess Margaret Cancer Centre ( Site 0109) | Toronto | Ontario |
| China | Beijing Cancer Hospital ( Site 0810) | Beijing | Beijing |
| China | Beijing Cancer Hospital ( Site 0811) | Beijing | Beijing |
| China | Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801) | Beijing | Beijing |
| China | Peking Union Medical College Hospital ( Site 0809) | Beijing | Beijing |
| China | Peking University Third Hospital ( Site 0812) | Beijing | Beijing |
| China | Hunan Cancer Hospital ( Site 0815) | Changsha | Hunan |
| China | Sun Yat-Sen University Cancer Center ( Site 0816) | Guangzhou | Guangdong |
| China | The First Affiliated Hospital of Zhejiang University ( Site 0804) | Hangzhou | Zhejiang |
| China | Zhejiang Cancer Hospital.... ( Site 0814) | Hangzhou | Zhejiang |
| China | Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802) | Ningbo | Zhejiang |
| China | Fudan University Shanghai Cancer Center ( Site 0813) | Shanghai | Shanghai |
| China | Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817) | Shanghai | Shanghai |
| China | Zhongshan Hospital of Fudan University ( Site 0808) | Shanghai | Shanghai |
| China | Tianjin Medical University General Hospital ( Site 0806) | Tianjin | Anhui |
| China | Tang Du Hospital ( Site 0803) | XI An | Shanxi |
| Estonia | SA Pohja-Eesti Regionaalhaigla ( Site 1100) | Tallinn | Harjumaa |
| France | Hôpital Avicenne - Service d oncologie medicale ( Site 0249) | Bobigny | Seine-Saint-Denis |
| France | Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245) | Chambery | Savoie |
| France | Clinique Francois Chenieux ( Site 0246) | Limoges | Haute-Vienne |
| France | Institut Curie ( Site 0250) | Paris | |
| France | Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241) | Pierre-Benite | Rhone-Alpes |
| France | Centre Hospitalier Annecy Genevois ( Site 0242) | Pringy | Savoie |
| France | CHU de Rouen ( Site 0252) | Rouen | Seine-Maritime |
| France | Nouvel Hopital Civil ( Site 0255) | Strasbourg | Bas-Rhin |
| France | Hopital Foch ( Site 0243) | Suresnes | Ain |
| France | H.I.A. Sainte-Anne ( Site 0251) | Toulon | Var |
| France | CHU de Toulouse - Hopital Larrey ( Site 0258) | Toulouse | Haute-Garonne |
| Germany | Zentralklinik Bad Berka GmbH ( Site 0264) | Bad Berka | Thuringen |
| Germany | Evangelische Lungenklinik Berlin ( Site 0274) | Berlin | |
| Germany | HELIOS Klinikum Emil von Behring ( Site 0280) | Berlin | |
| Germany | Universitaetsklinikum Carl Gustav Carus ( Site 0273) | Dresden | Sachsen |
| Germany | Florence Nightingale Krankenhaus ( Site 0874) | Duesseldorf | Nordrhein-Westfalen |
| Germany | Klinikum Esslingen GmbH ( Site 0875) | Esslingen | Baden-Wurttemberg |
| Germany | SRH Waldklinikum Gera GmbH ( Site 0272) | Gera | Thuringen |
| Germany | LungenClinic Grosshansdorf GmbH ( Site 0267) | Grosshansdorf | Schleswig-Holstein |
| Germany | Asklepios Klinikum Hamburg ( Site 0271) | Hamburg | |
| Germany | Lungenklinik Hemer ( Site 0269) | Hemer | Nordrhein-Westfalen |
| Germany | LKI Lungenfachklinik Immenhausen ( Site 0268) | Immenhausen | Hessen |
| Germany | Universitaetsklinikum Schleswig Holstein ( Site 0871) | Kiel | Schleswig-Holstein |
| Germany | Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873) | Koblenz | Rheinland-Pfalz |
| Germany | Universitaetsklinikum Leipzig AOeR ( Site 0277) | Leipzig | Sachsen |
| Germany | Mathias Spital Rheine ( Site 0261) | Rheine | Nordrhein-Westfalen |
| Ireland | St James Hospital ( Site 0451) | Dublin | |
| Ireland | Mid Western Cancer Centre ( Site 0450) | Limerick | |
| Ireland | Cork University Hospital ( Site 0452) | Wilton | Cork |
| Italy | Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307) | Brescia | |
| Italy | IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300) | Meldola | Forli-Cesena |
| Italy | ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315) | Milan | Milano |
| Italy | IRCCS Ospedale San Raffaele di Milano ( Site 0303) | Milano | |
| Italy | Istituto Nazionale Tumori ( Site 0309) | Milano | Abruzzo |
| Italy | Azienda Ospedaliera San Gerardo ( Site 0308) | Monza | Monza E Brianza |
| Italy | Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301) | Napoli | Campania |
| Italy | AOU San Luigi Gonzaga di Orbassano ( Site 0313) | Orbassano | Torino |
| Italy | Azienda Ospedaliera San Camillo Forlanini ( Site 0311) | Roma | |
| Italy | Istituto Clinico Humanitas Research Hospital ( Site 0314) | Rozzano | Lombardia |
| Japan | Hyogo Cancer Center ( Site 0764) | Akashi | Hyogo |
| Japan | Fukushima Medical University Hospital ( Site 0772) | Fukushima | |
| Japan | Hiroshima University Hospital ( Site 0762) | Hiroshima | |
| Japan | National Cancer Center Hospital East ( Site 0761) | Kashiwa | Chiba |
| Japan | St. Marianna University School of Medicine Hospital ( Site 0769) | Kawasaki | Kanagawa |
| Japan | HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770) | Kitakyushu | Fukuoka |
| Japan | Aichi Cancer Center Hospital ( Site 0765) | Nagoya | Aichi |
| Japan | Juntendo University Hospital ( Site 0768) | Tokyo | |
| Japan | National Cancer Center Hospital ( Site 0767) | Tokyo | |
| Japan | Tokyo Medical University Hospital ( Site 0771) | Tokyo | |
| Japan | Kanagawa Cancer Center ( Site 0763) | Yokohama | Kanagawa |
| Japan | Oita University Hospital ( Site 0766) | Yufu | Oita |
| Korea, Republic of | National Cancer Center ( Site 0702) | Gyeonggi-do | Kyonggi-do |
| Korea, Republic of | The Catholic University of Korea St. Vincent s Hospital ( Site 0705) | Gyeonggi-do | Kyonggi-do |
| Korea, Republic of | Asan Medical Center ( Site 0701) | Seoul | |
| Korea, Republic of | Samsung Medical Center ( Site 0704) | Seoul | |
| Korea, Republic of | SMG-SNU Boramae Medical Center ( Site 0707) | Seoul | |
| Latvia | Pauls Stradins Clinical University Hospital ( Site 0911) | Riga | |
| Latvia | Riga East Clinical University Hospital ( Site 0912) | Riga | |
| Lithuania | LSMUL Kauno Klinikos ( Site 0932) | Kaunas | |
| Lithuania | Nacionalinis Vezio Institutas ( Site 0931) | Vilnius | |
| Malaysia | University Malaya Medical Centre ( Site 0781) | Kuala Lumpur | |
| Malaysia | Sarawak General Hospital ( Site 0782) | Kuching | Sarawak |
| Poland | Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484) | Bystra | Dolnoslaskie |
| Poland | Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493) | Lodz | Lodzkie |
| Poland | Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487) | Poznan | Wielkopolskie |
| Poland | Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483) | Prabuty | Pomorskie |
| Poland | Dolnoslaskie Centrum Onkologii. ( Site 0491) | Wroclaw | Dolnoslaskie |
| Romania | Spitalul Sf. Constantin ( Site 0512) | Brasov | |
| Romania | Centrul Medical Medicover Victoria ( Site 0514) | Bucharest | Bucuresti |
| Romania | Euroclinic Hospital Bucharest ( Site 0510) | Bucuresti | |
| Romania | S.C.Focus Lab Plus S.R.L ( Site 0513) | Bucuresti | |
| Romania | Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501) | Cluj Napoca | Cluj |
| Romania | Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515) | Cluj-Napoca | Cluj |
| Romania | SC Radiotherapy Center Cluj SRL ( Site 0509) | Comuna Floresti | Cluj |
| Romania | Spitalul clinic Judetean de urgenta Constanta ( Site 0508) | Constanta | |
| Romania | S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504) | Craiova | Dolj |
| Romania | S C Pelican Impex SRL ( Site 0506) | Oradea | Bihor |
| Romania | S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511) | Otopeni | Ilfov |
| Romania | Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503) | Suceava | |
| Romania | S C Oncocenter Oncologie Medicala S R L ( Site 0505) | Timisoara | Timis |
| Russian Federation | Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530) | Chelyabinsk | Chelyabinskaya Oblast |
| Russian Federation | Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529) | Kazan | Tatarstan, Respublika |
| Russian Federation | Medical Rehabilitation Center ( Site 0534) | Moscow | Moskva |
| Russian Federation | N.N. Blokhin NMRCO ( Site 0521) | Moscow | Moskva |
| Russian Federation | National Medical Research Radiology Centre ( Site 0535) | Moscow | Moskva |
| Russian Federation | Municipal Clinical Oncology Center ( Site 0523) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SBHI Leningrad Regional Clinical Hospital ( Site 0524) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | Tomsk Scientific Research Institute of Oncology ( Site 0526) | Tomsk | Tomskaya Oblast |
| South Africa | The Oncology Centre ( Site 0571) | Durban | Kwazulu-Natal |
| South Africa | Cape Town Oncology Trials Pty Ltd ( Site 0572) | Kraaifontein | Western Cape |
| South Africa | Wits Clinical Research ( Site 0570) | Parktown-Johannesburg | Gauteng |
| South Africa | Wilgers Oncology Centre ( Site 0573) | Pretoria | Gauteng |
| Spain | Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381) | Badalona | Barcelona |
| Spain | Hospital de la Santa Creu i Sant Pau ( Site 0385) | Barcelona | |
| Spain | Hospital Universitari Vall d Hebron ( Site 0389) | Barcelona | |
| Spain | Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386) | Girona | La Coruna |
| Spain | Instituto Catalan de Oncologia - ICO ( Site 0388) | L Hospitalet De Llobregat | Barcelona |
| Spain | Hospital Universitario Insular de Gran Canaria ( Site 0383) | Las Palmas de Gran Canaria | Las Palmas |
| Spain | Hospital General Universitario Gregorio Maranon ( Site 0382) | Madrid | |
| Spain | Hospital Virgen del Rocio ( Site 0387) | Sevilla | |
| Taiwan | Kaohsiung Chang Gung Memorial Hospital ( Site 0725) | Kaohsiung | |
| Taiwan | China Medical University Hospital ( Site 0724) | Taichung | |
| Taiwan | National Taiwan University Hospital ( Site 0721) | Taipei | |
| Taiwan | Taipei Veterans General Hospital ( Site 0722) | Taipei | |
| Taiwan | Tri-Service General Hospital ( Site 0726) | Taipei | |
| Taiwan | Chang Gung Medical Foundation.Linkou Branch ( Site 0723) | Taoyuan | |
| Ukraine | Cherkassy Regional Oncological Center ( Site 0613) | Cherkasy | Cherkaska Oblast |
| Ukraine | City Clinical Hosp.4 of DCC ( Site 0607) | Dnipro | Dnipropetrovska Oblast |
| Ukraine | MI Precarpathian Clinical Oncology Center ( Site 0603) | Ivano-Frankivsk | Ivano-Frankivska Oblast |
| Ukraine | MI KhRC Kherson Regional Oncology Dispensary ( Site 0614) | Kherson | Khersonska Oblast |
| Ukraine | PP PPC Acinus Medical and Diagnostic Centre ( Site 0609) | Kropyvnytsky | Kirovohradska Oblast |
| Ukraine | Kyiv City Clinical Oncological Center ( Site 0601) | Kyiv | Kyivska Oblast |
| Ukraine | National Cancer Institute of the MoH of Ukraine ( Site 0605) | Kyiv | Kyivska Oblast |
| Ukraine | MI Odessa Regional Oncological Centre ( Site 0608) | Odesa | Odeska Oblast |
| Ukraine | Zaporizhzhya Regional Clinical Oncology Center ( Site 0606) | Zaporizhzhya | Zaporizka Oblast |
| United Kingdom | Heartlands Hospital in Birmingham ( Site 0455) | Birmingham | |
| United Kingdom | Leicester Royal Infirmary ( Site 0447) | Leicester | Leicestershire |
| United Kingdom | Royal Marsden NHS Foundation Trust ( Site 0458) | London | London, City Of |
| United Kingdom | Freeman Hospital ( Site 0444) | Newcastle upon Tyne | |
| United Kingdom | Nottingham City Hospital Campus ( Site 0441) | Nottingham | Nottinghamshire |
| United Kingdom | Plymouth Hospitals NHS Trust ( Site 0443) | Plymouth | |
| United Kingdom | Royal Marsden Hospital ( Site 0457) | Sutton | London, City Of |
| United Kingdom | The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456) | Wirral | Liverpool |
| United States | St. Peter's Hospital Cancer Care Center ( Site 0039) | Albany | New York |
| United States | Pacific Cancer Medical Center, Inc. ( Site 0004) | Anaheim | California |
| United States | Ashland-Bellefonte Cancer Center ( Site 0021) | Ashland | Kentucky |
| United States | Harry & Jeanette Weinberg Cancer Institute ( Site 0081) | Baltimore | Maryland |
| United States | Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074) | Basking Ridge | New Jersey |
| United States | St. Vincent Healthcare Frontier Cancer Center ( Site 0005) | Billings | Montana |
| United States | Boston Medical Center ( Site 0057) | Boston | Massachusetts |
| United States | Montefiore Einstein Center ( Site 0016) | Bronx | New York |
| United States | Providence Saint Joseph Medical Center ( Site 0061) | Burbank | California |
| United States | Emily Couric Clinical Cancer Center ( Site 0013) | Charlottesville | Virginia |
| United States | Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076) | Commack | New York |
| United States | Henry Ford Health System ( Site 0031) | Detroit | Michigan |
| United States | Northwest Oncology and Hematology ( Site 0001) | Elk Grove Village | Illinois |
| United States | Providence Regional Cancer Partnership ( Site 0065) | Everett | Washington |
| United States | Inova Schar Cancer Institute ( Site 0032) | Fairfax | Virginia |
| United States | Virginia Cancer Specialists, PC ( Site 0080) | Fairfax | Virginia |
| United States | PPG-Oncology ( Site 0043) | Fort Wayne | Indiana |
| United States | Banner MD Anderson Cancer Center ( Site 0028) | Gilbert | Arizona |
| United States | Western Regional Medical Center, Inc. ( Site 0050) | Goodyear | Arizona |
| United States | Saint Francis Cancer Center ( Site 0096) | Greenville | South Carolina |
| United States | UPMC Pinnacle Health System - East Location ( Site 0063) | Harrisburg | Pennsylvania |
| United States | Memorial Sloan Kettering Cancer Center Westchester ( Site 0079) | Harrison | New York |
| United States | Hartford Hospital ( Site 0069) | Hartford | Connecticut |
| United States | Ingalls Memorial Hospital ( Site 0044) | Harvey | Illinois |
| United States | University of Iowa Hospital and Clinics ( Site 0010) | Iowa City | Iowa |
| United States | Mayo Clinic Jacksonville ( Site 0022) | Jacksonville | Florida |
| United States | Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034) | Lansing | Michigan |
| United States | Miami Cancer Institute-Baptist Hospital ( Site 0068) | Miami | Florida |
| United States | Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077) | Middletown | New Jersey |
| United States | Pacific Cancer Care ( Site 0035) | Monterey | California |
| United States | MSKCC-Bergen ( Site 0075) | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center ( Site 0060) | New York | New York |
| United States | Helen F. Graham Cancer Center & Research Institute ( Site 0015) | Newark | Delaware |
| United States | Southeastern Regional Medical Center ( Site 0051) | Newnan | Georgia |
| United States | University of Nebraska Medical Center ( Site 0047) | Omaha | Nebraska |
| United States | Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053) | Philadelphia | Pennsylvania |
| United States | University of Arizona Cancer Center - Dignity Health ( Site 0062) | Phoenix | Arizona |
| United States | Allegheny General Hospital ( Site 0009) | Pittsburgh | Pennsylvania |
| United States | UPMC Hillman Cancer Centers ( Site 0041) | Pittsburgh | Pennsylvania |
| United States | VA Pittsburgh Healthcare System ( Site 0052) | Pittsburgh | Pennsylvania |
| United States | OHSU Center for Health & Healing ( Site 1006) | Portland | Oregon |
| United States | Mayo Clinic ( Site 0026) | Rochester | Minnesota |
| United States | John Wayne Cancer Institute ( Site 0049) | Santa Monica | California |
| United States | St Joseph Heritage Healthcare ( Site 0040) | Santa Rosa | California |
| United States | Stanford University, Stanford Cancer Center ( Site 0046) | Stanford | California |
| United States | Stony Brook University Medical Center - Cancer Center ( Site 0019) | Stony Brook | New York |
| United States | University of Arizona Cancer Center ( Site 0012) | Tucson | Arizona |
| United States | Southwestern Regional Medical Center, Inc. ( Site 0054) | Tulsa | Oklahoma |
| United States | Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078) | Uniondale | New York |
| United States | White Plains Hospital Center for Cancer Care ( Site 0007) | White Plains | New York |
| United States | UMass Memorial Medical Center ( Site 0030) | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Belgium, Brazil, Canada, China, Estonia, France, Germany, Ireland, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kingdom,
Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Keller SM, Samkari A, Spicer JD; KEYNOTE-671 Investigators. Perioperative Pembrolizu — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Event Free Survival (EFS) | EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using RECIST 1.1. | Up to approximately 5 years | |
| Primary | Overall Survival (OS) | OS is defined as the time from randomization until death from any cause. | Up to approximately 5 years | |
| Secondary | Major Pathological Response (mPR) Rate | mPR rate is defined as the percentage of participants having =10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. | Up to approximately 7 weeks following completion of neoadjuvant treatment (up to Study Week 20) | |
| Secondary | Pathological Complete Response (pCR) Rate | pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. | Up to approximately 7 weeks following completion of neoadjuvant treatment (up to Study Week 20) | |
| Secondary | Global Health Status/Quality of Life (GHS/QoL) Score using the European Organization for Research and Treatment (EORTC) QoL Questionnaire (QLQ-C30) | Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL. | Baseline (cycle 1 in neoadjuvant phase) and end of follow-up (up to approximately 5 years) | |
| Secondary | Adverse Events (AEs) | The number of participants experiencing an AE will be assessed. An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined. | Up to approximately 71 weeks | |
| Secondary | Perioperative Complications | The number of participants experiencing perioperative complications will be assessed. Perioperative complications are a discrete set of both intraoperative and postoperative complications, potentially contributing to increased length of inpatient care and/or delay of adjuvant therapy. | Up to approximately 51 weeks following surgery | |
| Secondary | Treatment Discontinuations Due to AEs | The number of participants discontinuing study therapy due to an AE will be assessed. | Up to approximately 57 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
| Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
| Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
| Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
| Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
| Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
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
|
Phase 1/Phase 2 | |
| Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
| Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
| Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |