Non Small Cell Lung CancerPhase 3TroFuse-019NCT06312137
A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
A Phase 3 study testing Sacituzumab tirumotecan, Pembrolizumab and Cisplatin in people with Non Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 270 sites in 31 countries.
Trial summary
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Sacituzumab tirumotecan, Pembrolizumab and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 270 sitesin 31 countries
- Study dates
- 3 Apr 2024to 23 Oct 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]) per AJCC eighth edition guidelines
- Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy
- Is able to undergo surgery based on opinion of investigator after consultation with surgeon
- Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy
- Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
- Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period
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- Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization
- Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention
Who cannot join
- Has one of the following tumor locations/types:
- NSCLC involving the superior sulcus
- Large cell neuro-endocrine cancer (LCNEC)
- Sarcomatoid tumor
- Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
- Has Grade ≥2 peripheral neuropathy
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- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
- Has received prior neoadjuvant therapy for their current NSCLC diagnosis
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- Has received an investigational agent or has used an investigational device within 4 weeks prior to 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 medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening
- Has an active infection requiring systemic therapy
- Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
- Has a history of allogeneic tissue/solid organ transplant
- Has not adequately recovered from major surgery or have ongoing surgical complications
- Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and/or to another biologic therapy
Trial locations and contacts
270 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
270 sites in 31 countries
United States51 sites, 45 recruiting
- Recruiting
Piedmont Atlanta Hospital ( Site 4000)
Atlanta, Georgia, 30318
Study Coordinator, 404-425-1777
- Recruiting
Emory University School of Medicine-Phase I ( Site 0056)
Atlanta, Georgia, 30322
Study Coordinator, 404-778-1900
- Recruiting
Northside Hospital ( Site 0055)
Atlanta, Georgia, 30342
Study Coordinator, 404-851-8000
- Recruiting
LSU Health Baton Rouge North Clinic ( Site 4003)
Baton Rouge, Louisiana, 70805
Study Coordinator, 225-765-7956
- Recruiting
Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080)
Baton Rouge, Louisiana, 70808
Study Coordinator, 225-765-7956
- Recruiting
Beverly Hills Cancer Center ( Site 0070)
Beverly Hills, California, 90211
Study Coordinator, 310-432-8933
- Recruiting
Saint Joseph's Candler Health System ( Site 4010)
Bluffton, South Carolina, 29910
Study Coordinator, 912-819-5704
- Recruiting
Medical University of South Carolina-Hollings Cancer Center ( Site 0045)
Charleston, South Carolina, 29425
Study Coordinator, 843-792-4271
- Completed
Centricity Research Columbus Cancer Center ( Site 0005)
Columbus, Georgia, 31904
- Recruiting
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061)
Edgewood, Kentucky, 41017
Study Coordinator, 859-301-4736
- Completed
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017)
Elmhurst, Illinois, 60126
- Recruiting
North Shore University Health System ( Site 4014)
Evanston, Illinois, 60201
Study Coordinator, 847-540-2112
- Recruiting
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057)
Fargo, North Dakota, 58102
Study Coordinator, 701-234-6161
- Recruiting
Parkview Research Center at Parkview Regional Medical Center ( Site 0089)
Fort Wayne, Indiana, 46845
Study Coordinator, 260-266-6626
- Recruiting
Penn State Milton S. Hershey Medical Center-Penn State Cancer Institute ( Site 0059)
Hershey, Pennsylvania, 17033
Study Coordinator, 717-531-0003
- Completed
Millennium Research & Clinical Development ( Site 0039)
Houston, Texas, 77090
- Recruiting
Cayuga Medical Center ( Site 0086)
Ithaca, New York, 14850
Study Coordinator, 607-277-4341
- Recruiting
Mayo Clinic in Florida ( Site 0014)
Jacksonville, Florida, 32224
Study Coordinator, 904-953-3570
- Recruiting
University of Tennessee Medical Center Knoxville ( Site 0082)
Knoxville, Tennessee, 37920
Study Coordinator, 865-305-9000
- Recruiting
Indiana University Health Arnett Cancer Center ( Site 0076)
Lafayette, Indiana, 47904
Study Coordinator, 765-838-6885
- Recruiting
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068)
Lancaster, Pennsylvania, 17601
Study Coordinator, 717-544-0511
- Recruiting
Accellacare of Duly ( Site 4005)
Lisle, Illinois, 60532
Study Coordinator, 630-545-7760
- Recruiting
UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)
Little Rock, Arkansas, 72205
Study Coordinator, 601-278-6499
- Completed
The Angeles Clinic and Research Institute ( Site 0040)
Los Angeles, California, 90025
- Completed
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)
Los Angeles, California, 90025
- Recruiting
UCLA Clinical & Translational Research Center (CTRC) ( Site 0033)
Los Angeles, California, 90095
Study Coordinator, 424-325-9070
- Recruiting
Mount Sinai Cancer Center ( Site 0038)
Miami Beach, Florida, 33140
Study Coordinator, 305-674-2625
- Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)
Minneapolis, Minnesota, 55407
Study Coordinator, 888-425-5462
- Recruiting
Atlantic Health Morristown Medical Center ( Site 0077)
Morristown, New Jersey, 07960
Study Coordinator, 973-971-7000
- Completed
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078)
Naperville, Illinois, 60540
- Recruiting
Southeastern Regional Medical Center ( Site 0065)
Newnan, Georgia, 30265
Study Coordinator, 770-400-6000
- Recruiting
Hoag Memorial Hospital Presbyterian ( Site 0096)
Newport Beach, California, 92663
Study Coordinator, 949-764-4060
- Recruiting
Hightower Clinical, LLC ( Site 0084)
Oklahoma City, Oklahoma, 73102
Study Coordinator, 405-479-8331
- Recruiting
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 4002)
Orange, California, 92868
Study Coordinator, 714-734-6220
- Recruiting
Mid Florida Hematology and Oncology Center ( Site 0018)
Orange City, Florida, 32763
Study Coordinator, 386-960-7070
- Recruiting
Oregon Health and Science University ( Site 0052)
Portland, Oregon, 97239
Study Coordinator, 503-494-0283
- Recruiting
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)
Reno, Nevada, 89502
Study Coordinator, 775-982-5050
- Recruiting
Mayo Clinic - Rochester ( Site 0073)
Rochester, Minnesota, 55905
Study Coordinator, 904-953-1050
- Recruiting
Huntsman Cancer Institute ( Site 0042)
Salt Lake City, Utah, 84112-5500
Study Coordinator, 801-587-7000
- Recruiting
San Francisco Oncology Associates ( Site 0066)
San Francisco, California, 94115
Study Coordinator, 415-600-1102
- Recruiting
Lewis Cancer and Research Pavilion ( Site 0063)
Savannah, Georgia, 31405
Study Coordinator, 912-819-5704
- Recruiting
Sanford Cancer Center ( Site 0053)
Sioux Falls, South Dakota, 57104
Study Coordinator, 605-328-8800
- Recruiting
Avera Cancer Institute- Research ( Site 0090)
Sioux Falls, South Dakota, 57105
Study Coordinator, 605-322-3295
- Recruiting
Highlands Oncology Group-Research Department ( Site 0062)
Springdale, Arkansas, 72762
Study Coordinator, 479-334-2562
- Recruiting
Mercy South - David M Sindelar Cancer Center ( Site 0098)
St Louis, Missouri, 63128
Study Coordinator, 314-525-4928
- Recruiting
Mercy Research - David C. Pratt Cancer Center ( Site 0006)
St Louis, Missouri, 63141
Study Coordinator, 314-251-4400
- Recruiting
Stamford Hospital ( Site 0083)
Stamford, Connecticut, 06902
Study Coordinator, 203-358-8879
- Recruiting
University Hospital at Stony Brook ( Site 0054)
Stony Brook, New York, 11794
Study Coordinator, 631-372-7212
- Recruiting
Archbold Cancer Center ( Site 0071)
Thomasville, Georgia, 31792
Study Coordinator, 229-584-5417
- Recruiting
New England Cancer Specialists ( Site 0095)
Westbrook, Maine, 04092
Study Coordinator, 207-303-3300
- Recruiting
White Plains Hospital ( Site 0091)
White Plains, New York, 10601
Study Coordinator, 914-681-0600
China27 sites, 26 recruiting
- Recruiting
Beijing Cancer hospital-Thoracic Surgery department I ( Site 1301)
Beijing, Beijing Municipality, 100010
Study Coordinator, 86-10-88121122
- Recruiting
Beijing Peking Union Medical College Hospital-Thoracic surgery department ( Site 1302)
Beijing, Beijing Municipality, 100730
Study Coordinator, 86-10-69151188
- Recruiting
Peking University People's Hospital ( Site 1300)
Beijing, Beijing Municipality, 101109
Study Coordinator, 01088326666
- Recruiting
The First Hospital of Jilin University ( Site 1324)
Changchun, Jilin, 130031
Study Coordinator, +86-431-81875309
- Recruiting
Xiangya Hospital Central South University-Thoracic surgery ( Site 1311)
Changsha, Hunan, 410008
Study Coordinator, 0731-89753003
- Recruiting
Hunan Cancer Hospital ( Site 1312)
Changsha, Hunan, 410013
Study Coordinator, 0731-89762112
- Recruiting
Sichuan Cancer hospital. ( Site 1327)
Chengdu, Sichuan, 610042
Study Coordinator, 028-85420156
- Recruiting
Fujian Cancer Hospital-oncology department ( Site 1314)
Fuzhou, Fujian, 350014
Study Coordinator, 0591-83660063
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 1320)
Guangzhou, Guangdong, 510120
Study Coordinator, +86 13660202355
- Recruiting
Southern Medical University Nanfang Hospital-Thoracic surgery department ( Site 1313)
Guangzhou, Guangdong, 510515
Study Coordinator, 020-61641821
- Recruiting
The first Affiliated Hospital, Zhejiang University School of-Thoracic Cardiovascular Surgery Ward ( Site 1303)
Hangzhou, Zhejiang, 310003
Study Coordinator, 0571-87236114
- Recruiting
Zhejiang Cancer Hospital ( Site 1309)
Hangzhou, Zhejiang, 310022
Study Coordinator, 0571-88128276
- Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 1328)
Hangzhou, Zhejiang, 31009
Study Coordinator, 0571-86006992
- Recruiting
Shandong Cancer Hospital ( Site 1321)
Jinan, Shandong, 250117
Study Coordinator, +86-531-67626232
- Recruiting
Yunnan Province Cancer Hospital ( Site 1315)
Kunming, Yunnan, 650107
Study Coordinator, 087168178106
- Recruiting
Taizhou Hospital of Zhejiang Province ( Site 1329)
Linhai, Zhejiang, 317000
Study Coordinator, 0576-85199810
- Recruiting
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 1330)
Nanchang, Jiangxi, 330209
Study Coordinator, 0791-88695051
- Recruiting
Nanjing First Hospital ( Site 1310)
Nanjing, Jiangsu, 210012
Study Coordinator, 025-52271064
- Completed
The Second People's Hospital of Neijiang ( Site 1322)
Neijiang, Sichuan, 641000
- Recruiting
Ningbo No. 2 Hospital ( Site 1305)
Ningbo, Zhejiang, 315010
Study Coordinator, 057483870375
- Recruiting
Zhongshan Hospital Fudan University ( Site 1325)
Shanghai, Shanghai Municipality, 200032
Study Coordinator, 02131587861
- Recruiting
Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 1304)
Shanghai, Shanghai Municipality, 200433
Study Coordinator, 021-65115006
- Recruiting
The First Affiliated Hospital of Soochow University-Thoracic Surgery Department ( Site 1318)
Suzhou, Jiangsu, 215006
Study Coordinator, 0512-67780040
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Thoracic Surgery ( Site 1306)
Wuhan, Hubei, 430022
Study Coordinator, 027-85351615
- Recruiting
Hubei Cancer Hospital ( Site 1308)
Wuhan, Hubei, 430079
Study Coordinator, 027-87670445
- Recruiting
The Second Affiliated Hospital of Air Force Medical University ( Site 1332)
Xi'an, Shaanxi, 710038
Study Coordinator, 02984756100
- Recruiting
Henan Cancer Hospital-henan cancer hospital ( Site 1316)
Zhengzhou, Henan, 450000
Study Coordinator, 0371-65588178
Japan20 sites, 20 recruiting
- Recruiting
Juntendo University Hospital ( Site 1204)
Bunkyo-ku, Tokyo, 113-8431
Study Coordinator, +81-3-3813-3111
- Recruiting
National Hospital Organization Kyushu Cancer Center ( Site 1218)
Fukuoka, 811-1395
Study Coordinator, +81-92-541-3231
- Recruiting
Fukushima Medical University Hospital ( Site 1200)
Fukushima, 960-1295
Study Coordinator, +81-24-547-1111
- Recruiting
Kansai Medical University Hospital ( Site 1211)
Hirakata, Osaka, 573-1191
Study Coordinator, +81-72-804-0101
- Recruiting
Hiroshima University Hospital ( Site 1215)
Hiroshima, 734-8551
Study Coordinator, +81-82-257-5555
- Recruiting
National Cancer Center Hospital East ( Site 1202)
Kashiwa, Chiba, 277-8577
Study Coordinator, +81-4-7133-1111
- Recruiting
St. Marianna University Hospital ( Site 1207)
Kawasaki, Kanagawa, 216-8511
Study Coordinator, +81-44-977-8111
- Recruiting
Saitama Prefectural Cancer Center ( Site 1201)
Kitaadachi-gun, Saitama, 3620806
Study Coordinator, +81-48-722-1111
- Recruiting
Hospital of the University of Occupational and Environmental Health, Japan ( Site 1217)
Kitakyushu, Fukuoka, 807-8556
Study Coordinator, +81-93-603-1611
- Recruiting
Kobe City Medical Center General Hospital ( Site 1213)
Kobe, Hyōgo, 650-0047
Study Coordinator, +81-78-302-4321
- Recruiting
National Hospital Organization Shikoku Cancer Center ( Site 1216)
Matsuyama, Ehime, 791-0280
Study Coordinator, +81-89-999-1111
- Recruiting
Nagasaki University Hospital ( Site 1220)
Nagasaki, 852-8501
Study Coordinator, +81-95-819-7200
- Recruiting
Niigata Cancer Center Hospital ( Site 1208)
Niigata, 951-8566
Study Coordinator, +81-25-266-5111
- Recruiting
Okayama University Hospital ( Site 1214)
Okayama, 700-8558
Study Coordinator, +81-86-235-7991
- Recruiting
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1210)
Osaka, 541-8567
Study Coordinator, +81-6-6945-1181
- Recruiting
Kindai University Hospital ( Site 1212)
Sakai, Osaka, 590-0197
Study Coordinator, +81-72-366-0221
- Recruiting
Tokyo Medical University Hospital ( Site 1203)
Shinjuku, Tokyo, 160-0023
Study Coordinator, +81-3-3342-6111
- Recruiting
Nippon Medical School Hospital ( Site 1205)
Tokyo, 113-8603
Study Coordinator, +81-3-3822-2131
- Recruiting
Yamagata University Hospital ( Site 1219)
Yamagata, 990-9585
Study Coordinator, +81-23-633-1122
- Recruiting
Kanagawa Cancer Center ( Site 1206)
Yokohama, Kanagawa, 241-8515
Study Coordinator, +81-45-520-2222
Italy14 sites, 14 recruiting
- Recruiting
Humanitas Gavazzeni-ONCOLOGY ( Site 2310)
Bergamo, 24125
Study Coordinator, +390354204106
- Recruiting
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 2307)
Florence, Tuscany, 50134
Study Coordinator, +390557947298
- Recruiting
Ospedale San Martino ( Site 2313)
Genova, 16132
Study Coordinator, +390105558918
- Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 2302)
Meldola, Emilia-Romagna, 47014
Study Coordinator, +393487469100
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 2300)
Milan, Lombardy, 20133
Study Coordinator, +390223903829
- Recruiting
San Paolo - ASST SANTI PAOLO E CARLO ( Site 2314)
Milan, Lombardy, 20142
Study Coordinator, +390240222119
- Recruiting
Ospedale San Raffaele-Oncologia Medica ( Site 2311)
Milan, 20132
Study Coordinator, +390226434856
- Recruiting
Humanitas Istituto Clinico Catanese ( Site 2315)
Misterbianco, Catania, 95045
Study Coordinator, +3909573390167
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2301)
Monza, Lombardy, 20900
Study Coordinator, +390392339285
- Recruiting
Azienda Ospedaliero Universitaria di Parma ( Site 2312)
Parma, 43126
Study Coordinator, +39521702660
- Recruiting
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 2303)
Pavia, 27100
Study Coordinator, +390382503938
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 2306)
Roma, 00168
Study Coordinator, +390630156318
- Recruiting
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 2309)
Rome, Roma, 00144
Study Coordinator, 0652665698
- Recruiting
APSS- Presidio Ospedaliero S. Chiara ( Site 2304)
Trento, 38122
Study Coordinator, +390461902478
Germany12 sites, 12 recruiting
- Recruiting
Zentralklinik Bad Berka-Klinik für Hämatologie und Onkologie ( Site 1902)
Bad Berka, Thuringia, 99437
Study Coordinator, +493645851501
- Recruiting
Evangelische Lungenklinik Berlin-Pneumologie ( Site 1904)
Berlin, 13125
Study Coordinator, +4930948020
- Recruiting
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1903)
Berlin, 13353
Study Coordinator, +4930450553412
- Recruiting
Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- ( Site 1912)
Berlin, 13585
Study Coordinator, 4930130132629
- Recruiting
Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1916)
Berlin, 14165
Study Coordinator, +493081021506
- Recruiting
Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1914)
Esslingen am Neckar, Baden-Wurttemberg, 73730
Study Coordinator, 71131032402
- Recruiting
SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1900)
Gera, Thuringia, 07548
Study Coordinator, +493658282151
- Recruiting
Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 1908)
Halle, Saxony-Anhalt, 06120
Study Coordinator, +493455591434
- Recruiting
Lungenklinik Hemer ( Site 1905)
Hemer, North Rhine-Westphalia, 58675
Study Coordinator, 02372 9080
- Recruiting
Katholisches Klinikum Koblenz ( Site 1911)
Koblenz, Rhineland-Palatinate, 56073
Study Coordinator, 00492614964095
- Recruiting
Universitätsklinikum Leipzig ( Site 1915)
Leipzig, Saxony, 04103
Study Coordinator, 00493419712600
- Recruiting
Universitaetsklinikum Regensburg ( Site 1907)
Regensburg, Bavaria, 93053
Study Coordinator, +499419447285
Romania11 sites, 9 recruiting
- Recruiting
SC ONCO CARD SRL ( Site 2808)
Brasov, 500052
Study Coordinator, +40268960
- Recruiting
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L.. ( Site 2803)
Bucharest, Bucharest, 013823
Study Coordinator, +40319393
- Recruiting
Institutul Oncologic Bucuresti Prof.Dr. Alex. Trestioreanu ( Site 2809)
Bucharest, Bucharest, 022328
Study Coordinator, +40212271000
- Recruiting
SC MNT HEALTHCARE EUROPE SRL ( Site 2811)
Bucharest, 013975
Study Coordinator, +40 21 9230
- Recruiting
Delta Health Care SRL ( Site 2810)
Bucharest, 014142
Study Coordinator, +40 21 9977
- Recruiting
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu ( Site 2804)
Bucharest, 077015
Study Coordinator, +40213161600
- Completed
Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2801)
Cluj-Napoca, Cluj, 400015
- Completed
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2805)
Craiova, Dolj, 200542
- Recruiting
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2802)
Florești, Cluj, 407280
Study Coordinator, +40219368
- Recruiting
Institutul Regional de Oncologie ( Site 2807)
Iași, 700483
Study Coordinator, +40374.278.811
- Recruiting
Spitalul Clinic Municipal De Urgenta Timisoara ( Site 2806)
Timișoara, Timiș County, 300595
Study Coordinator, +40256200048
France10 sites, 10 recruiting
- Recruiting
CHRU de Brest ( Site 1804)
Brest, Finistere, 29609
Study Coordinator, +33298223298
- Recruiting
Hospices Civils de Lyon - Hopital Louis Pradel ( Site 1809)
Bron, Rhone, 69677
Study Coordinator, +33427855594
- Recruiting
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1810)
Clermont-Ferrand, Puy-de-Dome, 63003
Study Coordinator, +33473278080
- Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1805)
Limoges, Haute-Vienne, 87042
Study Coordinator, 33555056892
- Recruiting
Hôpital Tenon ( Site 1802)
Paris, 75020
Study Coordinator, 33156016531
- Recruiting
Groupe hospitalier Paris saint Joseph. ( Site 1807)
Paris, Île-de-France Region, 75014
Study Coordinator, +33144123159
- Recruiting
CHU Charles Nicolle ( Site 1803)
Rouen, Haute-Normandie, 76000
Study Coordinator, +33232888079
- Recruiting
HIA Sainte Anne ( Site 1800)
Toulon, Var, 83800 Cede
Study Coordinator, 0033483162937
- Recruiting
CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1801)
Toulouse, Haute-Garonne, 31400
Study Coordinator, +33567771859
- Recruiting
Clinique Teissier Groupe ( Site 1811)
Valenciennes, Nord, 59304
Study Coordinator, +33327142434
Poland10 sites, 8 recruiting
- Recruiting
Bialostockie Centrum Onkologii ( Site 2604)
Bialystok, Podlaskie Voivodeship, 15-027
Study Coordinator, +48856646732
- Recruiting
Uniwersytecki Szpital Kliniczny w Białymstoku ( Site 2612)
Bialystok, Podlaskie Voivodeship, 15-540
Study Coordinator, 858316522
- Active, not recruiting
Uniwersyteckie Centrum Kliniczne ( Site 2610)
Gdansk, Pomeranian Voivodeship, 80-214
- Recruiting
Krakowski Szpital Specjalistyczny im. Jana Pawła II ( Site 2614)
Krakow, Lesser Poland Voivodeship, 31-202
Study Coordinator, +48126142000
- Recruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie ( Site 2611)
Lublin, Lublin Voivodeship, 20-090
Study Coordinator, +48 602405127
- Recruiting
Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2606)
Olsztyn, Warmian-Masurian Voivodeship, 10-357
Study Coordinator, +48895322935
- Completed
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 2602)
Poznan, Greater Poland Voivodeship, 60-569
- Recruiting
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 2613)
Prabuty, Pomeranian Voivodeship, 82-550
Study Coordinator, +48 552624328
- Recruiting
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2601)
Przemyśl, Podkarpackie Voivodeship, 37-700
Study Coordinator, +48166775000
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2600)
Warsaw, Masovian Voivodeship, 02-781
Study Coordinator, +48225463066
Greece8 sites, 8 recruiting
- Recruiting
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2000)
Athens, Attica, 115 27
Study Coordinator, +302107700220
- Recruiting
Athens Medical Center ( Site 2005)
Athens, Attica, 151 25
Study Coordinator, +302106157392
- Recruiting
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2001)
Heraklion, Irakleio, 715 00
Study Coordinator, 0030 2810392438
- Recruiting
University General Hospital of Larissa-Oncology Clinic ( Site 2004)
Larissa, Thessaly, 411 10
Study Coordinator, +302413502124
- Recruiting
Athens Medical Center ( Site 2003)
Marousi, Attica, 151 25
Study Coordinator, 0030 2107464642
- Recruiting
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 2006)
Pátrai, Achaia, 26504
Study Coordinator, +302610999791
- Recruiting
Metaxa Cancer Hospital of Piraeus ( Site 2002)
Piraeus, Attica, 185 37
Study Coordinator, +302132079225
- Recruiting
European Interbalkan Medical Center ( Site 2007)
Thessaloniki, 570 01
Study Coordinator, 0030 2310400213
Netherlands8 sites, 8 recruiting
- Recruiting
Meander Medisch Centrum-Researchbureau Longgeneeskunde ( Site 3458)
Amersfoort, Utrecht, 3813TZ
Study Coordinator, +31338507843
- Recruiting
Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 3453)
Breda, North Brabant, 4818 CK
Study Coordinator, +0765955349
- Recruiting
University Medical Center Groningen ( Site 3459)
Groningen, 9713 GZ
Study Coordinator, 0503616161
- Recruiting
Martini Ziekenhuis ( Site 3460)
Groningen, 9728 NT
Study Coordinator, 0505246311
- Recruiting
Leids Universitair Medisch Centrum-Longziekten ( Site 3451)
Leiden, South Holland, 2333 ZG
Study Coordinator, 0715262950
- Recruiting
Erasmus Medisch Centrum ( Site 3452)
Rotterdam, South Holland, 3015 GD
Study Coordinator, +0107030323
- Recruiting
Sint Antonius Ziekenhuis ( Site 3455)
Utrecht, 3543 AZ
Study Coordinator, +0883201411
- Recruiting
Isala, locatie Zwolle-Poli Longziekten ( Site 3454)
Zwolle, Overijssel, 8025 BK
Study Coordinator, +0031655804447
Turkey (Türkiye)8 sites, 8 recruiting
- Recruiting
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3106)
Adana, 01140
Study Coordinator, +903223444444
- Recruiting
Gulhane Egitim Arastirma Hastanesi-Onkoloji ( Site 3104)
Ankara, 06010
Study Coordinator, 00903123042000
- Recruiting
Hacettepe Universite Hastaneleri-oncology hospital ( Site 3101)
Ankara, 06230
Study Coordinator, +90 (312) 305 50 00
- Recruiting
Memorial Ankara Hastanesi-Medical Oncology ( Site 3110)
Ankara, 06520
Study Coordinator, 903122536666
- Recruiting
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3103)
Ankara, 06800
Study Coordinator, +90 312 552 60 00
- Recruiting
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3107)
Istanbul, 34722
Study Coordinator, +902165666614
- Recruiting
Erciyes Universitesi Tıp Fakultesi Hastanesi ( Site 3111)
Kayseri, 38039
Study Coordinator, 905388731881
- Recruiting
Ondokuz Mayıs Universitesi ( Site 3112)
Korfez Mahallesi, Samsun, 55270
Study Coordinator, +903623121919
Argentina7 sites, 7 recruiting
- Recruiting
Hospital Aleman-Oncology ( Site 0202)
Buenos Aires, C1118AAT
Study Coordinator, +541148277000
- Recruiting
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB
Study Coordinator, +541149590200
- Recruiting
Hospital Británico de Buenos Aires-Oncology ( Site 0207)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB
Study Coordinator, +541143096400
- Recruiting
Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204)
Córdoba, X5016KEH
Study Coordinator, +543514688200
- Recruiting
Sanatorio Británico-Clinical Oncology Department ( Site 0206)
Rosario, Santa Fe Province, S2000CVB
Study Coordinator, 5493416575134
- Recruiting
Sanatorio Parque ( Site 0205)
Rosario, Santa Fe Province, S2000DSV
Study Coordinator, 5493416955611
- Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 0217)
San Miguel de Tucumán, Tucumán Province, T4000IHE
Study Coordinator, 543814752113
Brazil7 sites, 7 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0304)
Barretos, São Paulo, 14784400
Study Coordinator, +551733216638 ex6638
- Recruiting
Liga Norte Riograndense Contra o Câncer ( Site 0301)
Natal, Rio Grande do Norte, 59062-000
Study Coordinator, +558440095595
- Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0303)
Porto Alegre, Rio Grande do Sul, 90020-090
Study Coordinator, 51997292910
- Recruiting
Hospital Nossa Senhora da Conceição ( Site 0302)
Porto Alegre, Rio Grande do Sul, 91350-200
Study Coordinator, +555133572296
- Recruiting
Instituto de Oncologia Saint Gallen ( Site 0319)
Santa Cruz do Sul, Rio Grande do Sul, 96830-180
Study Coordinator, +55513056-8686
- Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0313)
São José do Rio Preto, São Paulo, 15090-000
Study Coordinator, +55 1798135-0180
- Recruiting
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 0305)
São Paulo, 01246-000
Study Coordinator, +551138932632
South Korea7 sites, 7 recruiting
- Recruiting
Chungbuk National University Hospital-Internal medicine ( Site 1000)
Cheongju-si, North Chungcheong, 28644
Study Coordinator, +82-43-269-6015
- Recruiting
Keimyung University Dongsan Hospital CRC room 1 ( Site 1006)
Daegu, Taegu-Kwangyokshi, 42601
Study Coordinator, +82532586671
- Recruiting
National Cancer Center-Lung Cancer Center ( Site 1002)
Goyang-si, Kyonggi-do, 10408
Study Coordinator, +82319201694
- Recruiting
Seoul National University Bundang Hospital-Medical Oncology ( Site 1003)
Seongnam, Kyonggi-do, 13620
Study Coordinator, +82-31-787-7071
- Recruiting
Asan Medical Center-Lung Cancer Center ( Site 1005)
Seoul, 05505
Study Coordinator, +82319201694
- Recruiting
Samsung Medical Center-Division of Hematology/Oncology ( Site 1004)
Seoul, 06351
Study Coordinator, 82-2-3410-3453
- Recruiting
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1001)
Suwon, Kyonggi-do, 16247
Study Coordinator, 82-31-249-8455
Taiwan7 sites, 6 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1103)
Kaohsiung City, 807
Study Coordinator, +88673121101
- Recruiting
Taichung Veterans General Hospital-Chest ( Site 1101)
Taichung, 40705
Study Coordinator, +886423592525x3256
- Completed
National Cheng Kung University Hospital-Clinical Trial Center ( Site 1102)
Tainan, 704
- Recruiting
National Taiwan University Hospital-Oncology ( Site 1104)
Taipei, 10002
Study Coordinator, +886223123456x267511
- Recruiting
National Taiwan University Cancer Center (NTUCC) ( Site 1105)
Taipei City, Taipei, 106
Study Coordinator, +886223123456x271659
- Recruiting
Tri-Service General Hospital ( Site 1100)
Taipei City, Taipei, 114
Study Coordinator, +886287923311x13899
- Recruiting
Taoyuan General Hospital ( Site 1106)
Taoyuan City, Taoyuan, 33004
Study Coordinator, +88633699721x8502
Mexico6 sites, 6 recruiting
- Recruiting
Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 0504)
Chihuahua City, 31123
Study Coordinator, +52 614 455 9270
- Recruiting
Mediadvance Clinical ( Site 0502)
Chihuahua City, 31203
Study Coordinator, +52 614 674 0705
- Recruiting
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0506)
Guadalajara, Jalisco, 44630
Study Coordinator, +52 33 3044 7001
- Recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0508)
Monterrey, Nuevo León, 64460
Study Coordinator, 5519336943
- Recruiting
Centro de Investigacion Clinica de Oaxaca ( Site 0509)
Oaxaca City, Oaxaca, 68020
Study Coordinator, 951209524
- Recruiting
Oaxaca Site Management Organization S.C. ( Site 0507)
Oaxaca City, 68000
Study Coordinator, 529515147056
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2900)
Barcelona, 08035
Study Coordinator, +34932746000
- Recruiting
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2901)
L'Hospitalet de Llobregat, Barcelona, 08908
Study Coordinator, +34932607744
- Recruiting
Hospital Insular de Gran Canaria-Oncology ( Site 2903)
Las Palmas de Gran Canaria, Las Palmas, 35016
Study Coordinator, +34 928441738
- Recruiting
Hospital Clinico San Carlos-Oncology Department ( Site 2904)
Madrid, 28040
Study Coordinator, 34 913303000 x484835
- Recruiting
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2902)
Pozuelo de Alarcón, Madrid, 28223
Study Coordinator, 34914521987
- Recruiting
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2905)
Santiago de Compostela, La Coruna, 15706
Study Coordinator, +34981950511
Chile5 sites, 5 recruiting
- Recruiting
FALP-UIDO ( Site 0401)
Providencia, Region M. de Santiago, 7500921
Study Coordinator, +56224205098
- Recruiting
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0404)
Santiago, Region M. de Santiago, 7500653
Study Coordinator, +56991612199
- Recruiting
Clínica RedSalud Vitacura ( Site 0412)
Santiago, Region M. de Santiago, 7650018
Study Coordinator, +56 9 8292 6243
- Recruiting
Bradfordhill-Clinical Area ( Site 0400)
Santiago, Region M. de Santiago, 8420383
Study Coordinator, +56229490970
- Recruiting
ONCOCENTRO APYS-ACEREY ( Site 0410)
Viña del Mar, Valparaiso, 2520598
Study Coordinator, +56323320850
Peru5 sites, 5 recruiting
- Recruiting
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0604)
Lima, 15036
Study Coordinator, +51 956 754 968
- Recruiting
Oncosalud ( Site 0602)
Lima, 15036
Study Coordinator, +51 988 966 244
- Recruiting
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 0600)
Lima, 15038
Study Coordinator, +51 957511783
- Recruiting
Instituto Neuro Cardiovascular de las Americas ( Site 0607)
Lima, 15038
Study Coordinator, +51 991366612
- Recruiting
Hospital Nacional Edgardo Rebagliati Martins-medical oncology ( Site 0603)
Lima, Lima11
Study Coordinator, +51998870468
United Kingdom5 sites, 5 recruiting
- Recruiting
Addenbrooke's Hospital ( Site 3217)
Cambridge, Cambridgeshire, CB2 2QQ
Study Coordinator, +441223 805000
- Recruiting
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3203)
London, London, City of, EC1A 7BE
Study Coordinator, 02073777000
- Recruiting
Freeman Hospital-Northern Centre for Cancer Care ( Site 3212)
Newcastle upon Tyne, NE7 7DN
Study Coordinator, 01912336161
- Recruiting
Mount Vernon Hospital ( Site 3218)
Northwood, Hillingdon, HA6 2RN
Study Coordinator, 02038262403
- Recruiting
Churchill Hospital ( Site 3219)
Oxford, Oxfordshire, OX3 7LE
Study Coordinator, +44 (0) 300 304 7777
Austria4 sites, 4 recruiting
- Recruiting
Medizinische Universitaet Innsbruck-Department for Internal Medicine V ( Site 1403)
Innsbruck, Tyrol, 6020
Study Coordinator, 43512 50480308
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 1402)
Linz, Upper Austria, 4020
Study Coordinator, 4373276764428
- Recruiting
Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 1401)
Vienna, 1140
Study Coordinator, 4319106042008
- Recruiting
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1400)
Vienna, 1210
Study Coordinator, 431277002237
Canada4 sites, 4 recruiting
- Recruiting
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0100)
Greenfield Park, Quebec, J4V 2H1
Study Coordinator, 450-466-5000#3226
- Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0104)
Montreal, Quebec, H2X 3E4
Study Coordinator, 5148908000x26214
- Recruiting
St. Marys Hospital Center ( Site 0107)
Montreal, Quebec, H3T 1M5
Study Coordinator, 514-345-3511
- Recruiting
McGill University Health Centre ( Site 0105)
Montreal, Quebec, H4A 3J1
Study Coordinator, 5149341934X36675
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus-Oncology Division ( Site 2203)
Haifa, 3109601
Study Coordinator, +972-4-7776234
- Recruiting
Shaare Zedek Medical Center ( Site 2206)
Jerusalem, 9103102
Study Coordinator, +97226555768
- Recruiting
Rabin Medical Center ( Site 2204)
Petah Tikva, 4941492
Study Coordinator, +97239378086
- Recruiting
Sheba Medical Center ( Site 2200)
Ramat Gan, 5265601
Study Coordinator, +972-35307032
Norway4 sites, 4 recruiting
- Recruiting
Drammen Sykehus, Vestre Viken HF ( Site 2502)
Drammen, Buskerud, 3004
Study Coordinator, +4732803000
- Recruiting
Sykehuset Innlandet HF Gjøvik ( Site 2503)
Gjøvik, Oppland, 2819
Study Coordinator, +4791 50 62 00
- Recruiting
Akershus Universitetssykehus ( Site 2501)
Lørenskog, Akershus, 1478
Study Coordinator, +4767960000
- Recruiting
Oslo universitetssykehus HF. Radiumhospitalet ( Site 2504)
Oslo, 0379
Study Coordinator, +4722934000
Portugal4 sites, 4 recruiting
- Recruiting
Instituto Portugês de Oncologia de Coimbra Francisco Gentil-Oncologia Médica ( Site 2704)
Coimbra, 3000-075
Study Coordinator, (351)217229800
- Recruiting
Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2703)
Lisbon, Lisbon District, 1769-001
Study Coordinator, (351)217548085
- Recruiting
UNIDADE LOCAL DE SAUDE DE MATOSINHOS-Serviço de Oncologia ( Site 2705)
Matosinhos Municipality, Porto District, 4464-513
Study Coordinator, (351) 229391233
- Recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2702)
Porto, 4200-072
Study Coordinator, (351)225084000
Switzerland4 sites, 4 recruiting
- Recruiting
Kantonsspital Graubünden-Medizin ( Site 3006)
Chur, Kanton Graubünden, 7000
Study Coordinator, +41812566646
- Recruiting
HFR Fribourg - Hôpital Cantonal ( Site 3004)
Fribourg, 1708
Study Coordinator, +41263062015
- Recruiting
CHUV (centre hospitalier universitaire vaudois) ( Site 3003)
Lausanne, Canton of Vaud, 1011
Study Coordinator, +41795560440
- Recruiting
Kantonsspital Münsterlingen - Spital Thurgau AG ( Site 3005)
Münsterlingen, Thurgau, 8596
Study Coordinator, +41 58 144 1563
Australia3 sites, 3 recruiting
- Recruiting
The Prince Charles Hospital ( Site 0700)
Brisbane, Queensland, 4032
Study Coordinator, +61736470368
- Recruiting
Fiona Stanley Hospital-Medical Oncology ( Site 0705)
Murdoch, Western Australia, 6150
Study Coordinator, 08 61526530
- Recruiting
Westmead Hospital ( Site 0701)
Westmead, New South Wales, 2145
Study Coordinator, 0298455200
Belgium3 sites, 3 recruiting
- Recruiting
Antwerp University Hospital-Thoracic Oncology ( Site 1503)
Edegem, Antwerpen, 2650
Study Coordinator, +32 3 821 56 81
- Recruiting
VITAZ ( Site 1500)
Sint-Niklaas, Oost-Vlaanderen, 9100
Study Coordinator, +32 3760 2926
- Recruiting
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 1502)
Yvoir, Namur, 5530
Study Coordinator, 081423351
Hong Kong3 sites, 3 recruiting
- Recruiting
Queen Mary Hospital ( Site 3400)
Hksar
Study Coordinator, +852 2255 3838
- Recruiting
Hong Kong United Oncology Centre ( Site 3403)
Kowloon
Study Coordinator, +852 2386 8002
- Recruiting
Queen Elizabeth Hospital ( Site 3402)
Yau Ma Tei, 999077
Study Coordinator, +852 3506 8888
Czechia2 sites, 2 recruiting
- Recruiting
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1600)
Brno, Brno-mesto, 656 53
Study Coordinator, +420543134008
- Recruiting
Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1601)
Ostrava, Ostrava Mesto, 703 00
Study Coordinator, +420595633400
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital ( Site 0800)
Auckland, 1023
Study Coordinator, +6493074949
About this study
Official title: A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Sacituzumab tirumotecan, Pembrolizumab, Cisplatin, Pemetrexed, Gemcitabine
- Keywords
- Carcinoma, Lung cancer, Non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab tirumotecanBiological
Also called MK-2870, sac-TMT, SKB264
Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks
PembrolizumabBiological
Also called MK-3475
Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
CisplatinDrug
Cisplatin is administered as 75 mg/m^2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase
PemetrexedDrug
Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m^2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.
GemcitabineDrug
Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m^2 or 1250 mg/m^2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.
CarboplatinDrug
Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.
PaclitaxelDrug
Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m^2 or 200 mg/m^2 IV infusion q3w for up to 12 weeks as background treatment.
Rescue medicationDrug
Participants are permitted to take rescue medications to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. Rescue medications include antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and granulocyte colony-stimulating factor. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Sacituzumab tirumotecan | Experimental | Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 12 doses (~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (~42 weeks). Receives: Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab; Drug: Rescue medication |
| Pembrolizumab | Active comparator | Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (~42 weeks). Receives: Biological: Pembrolizumab; Drug: Cisplatin; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Measured: Up to ~ 93 months
Secondary outcomes (12)
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to ~ 118 months
Distant metastasis-free survival (DMFS) as assessed by investigator
DMFS is defined as the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.
Measured: Up to ~ 118 months
Disease-Free Survival (DFS) as assessed by investigator
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Measured: Up to ~ 118 months
Lung Cancer Specific Survival (LCSS)
LCSS is defined as the time from randomization to the date of death due to lung cancer.
Measured: Up to ~ 118 months
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to ~ 118 months
Number of Participants Who Discontinue Study Intervention Due to AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be presented.
Measured: Up to ~ 118 months
Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30)
The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is a psychometrically and clinically validated instrument appropriate for assessing the health-related quality of life (HRQoL) of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for the global health status or QoL a higher value indicates a better level of function.
Measured: Baseline and up to ~118 months
Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5)
The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for all physical functional scales, a higher value indicates a better level of function.
Measured: Baseline and up to ~118 months
Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7)
The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for all role functional scales, a higher value indicates a better level of function.
Measured: Baseline and up to ~118 months
Change from Baseline in Dyspnea scores (QLQ-C30 Item 8)
The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for symptom scales such as dyspnea, a higher value indicates increased severity of symptoms.
Measured: Baseline and up to ~118 months
Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52)
The lung cancer module of the EORTC, QLQ-LC24 is a revised and updated version of the Lung Cancer Module QLQ-LC13 and is a supplementary lung cancer specific module to be used along with EORTC QLQ C30. The QLQ-LC24 incorporates 4 multi-item scales to assess coughing, shortness of breath, hair problems, and fear of progression, for symptom scales as for cough, a higher value indicates increased severity of symptoms.
Measured: Baseline and up to ~118 months
Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)
The lung cancer module of the EORTC, QLQ-LC24 is a revised and updated version of the Lung Cancer Module QLQ-LC13 and is a supplementary lung cancer specific module to be used along with EORTC QLQ C30. The QLQ-LC24 incorporates 4 multi-item scales to assess coughing, shortness of breath, hair problems, and fear of progression, for symptom scales as for chest pain, a higher value indicates increased severity of symptoms.
Measured: Baseline and up to ~118 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start3 Apr 2024
- Primary completion21 Feb 2034 (estimated)
- Study completion23 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi site study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312137
- Sponsor's protocol ID
- 2870-019
- Other IDs
- 2023-508012-35-00, MK-2870-019, jRCT2021240020, U1111-1297-4260, 2023
- Acronym
- TroFuse-019
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
- ClinicalTrials.gov ID
- NCT06312137
- Acronym / sponsor ID
- TroFuse-019 / 2870-019
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Carcinoma, Lung cancer, Non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 21 Feb 2034 (estimated)
- Study completion
- 23 Oct 2034 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multi site study
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + Sacituzumab tirumotecan | Experimental | Biological: Sacituzumab tirumotecan, Biological: Pembrolizumab, Drug: Rescue medicationParticipants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 12 doses (~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (~42 weeks). |
| Pembrolizumab | Active comparator | Biological: Pembrolizumab, Drug: Cisplatin, Drug: Pemetrexed, Drug: Gemcitabine, Drug: Carboplatin, Drug: PaclitaxelParticipants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (~42 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]) per AJCC eighth edition guidelines
- Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy
- Is able to undergo surgery based on opinion of investigator after consultation with surgeon
- Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy
- Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
Key exclusion criteria (24 listed)
- Has one of the following tumor locations/types:
- Has Grade ≥2 peripheral neuropathy
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab tirumotecanAlso: MK-2870, sac-TMT, SKB264Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks | Biological | Pembrolizumab + Sacituzumab tirumotecan |
| PembrolizumabAlso: MK-3475Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks | Biological | Pembrolizumab, Pembrolizumab + Sacituzumab tirumotecan |
| CisplatinCisplatin is administered as 75 mg/m^2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase | Drug | Pembrolizumab |
| PemetrexedPemetrexed will be administered in the neoadjuvant phase as 500 mg/m^2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC. | Drug | Pembrolizumab |
| GemcitabineGemcitabine will be administered in the neoadjuvant phase as 1000 mg/m^2 or 1250 mg/m^2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC. | Drug | Pembrolizumab |
| CarboplatinCarboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment. | Drug | Pembrolizumab |
| PaclitaxelPaclitaxel will be administered in the neoadjuvant phase as 175 mg/m^2 or 200 mg/m^2 IV infusion q3w for up to 12 weeks as background treatment. | Drug | Pembrolizumab |
| Rescue medicationParticipants are permitted to take rescue medications to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. Rescue medications include antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and granulocyte colony-stimulating factor. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis. | Drug | Pembrolizumab + Sacituzumab tirumotecan |
Primary outcome
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)
Time frame: Up to ~ 93 months
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
12 secondary outcomes
Overall Survival (OS)
Time frame: Up to ~ 118 months
Distant metastasis-free survival (DMFS) as assessed by investigator
Time frame: Up to ~ 118 months
Disease-Free Survival (DFS) as assessed by investigator
Time frame: Up to ~ 118 months
Lung Cancer Specific Survival (LCSS)
Time frame: Up to ~ 118 months
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to ~ 118 months
Number of Participants Who Discontinue Study Intervention Due to AEs
Time frame: Up to ~ 118 months
Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30)
Time frame: Baseline and up to ~118 months
Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5)
Time frame: Baseline and up to ~118 months
Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7)
Time frame: Baseline and up to ~118 months
Change from Baseline in Dyspnea scores (QLQ-C30 Item 8)
Time frame: Baseline and up to ~118 months
Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52)
Time frame: Baseline and up to ~118 months
Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)
Time frame: Baseline and up to ~118 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
270 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sacituzumab tirumotecan, Pembrolizumab and Cisplatin in people with Non Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 270 sites in 31 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 270 sites in United States, China, Japan, Italy, Germany and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR) (time frame: Up to ~ 93 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.