Non-small Cell Lung Cancer (NSCLC)Phase 3TroFuse-007NCT06170788
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
A Phase 3 study testing Sacituzumab tirumotecan, Pembrolizumab and Supportive care measures in people with Non-small Cell Lung Cancer (NSCLC), run by Merck Sharp & Dohme LLC at 220 sites in 26 countries.
Trial summary
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Sacituzumab tirumotecan, Pembrolizumab and Supportive care measures
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 220 sitesin 26 countries
- Study dates
- 15 Dec 2023to 27 May 2030
- Phase
- Phase 3
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
- Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
- Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
- Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
- A life expectancy of at least 3 months.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Who cannot join
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- Has Grade ≥2 peripheral neuropathy.
- 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 clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
- Received prior systemic anticancer therapy for their metastatic NSCLC.
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- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
- Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
- Active infection requiring systemic therapy
- Concurrent active Hepatitis B and Hepatitis C virus infection.
- Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- History of allogeneic tissue/solid organ transplant.
- Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.
Trial locations and contacts
220 sites in 26 countries. Contact the study team or a site near you to ask about taking part.
220 sites in 26 countries
China32 sites
- Active, not recruiting
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 3101)
Beijing, Beijing Municipality, 100142
- Active, not recruiting
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100)
Beijing, Beijing Municipality, 100730
- Active, not recruiting
Jilin Province Tumor Hospital-oncology department ( Site 3126)
Changchun, Jilin, 130000
- Active, not recruiting
The Second Xiangya Hospital of Central South University ( Site 3138)
Changsha, Hunan, 410011
- Active, not recruiting
West China Hospital, Sichuan University ( Site 3124)
Chengdu, Sichuan, 610041
- Completed
Sichuan Cancer hospital. ( Site 3105)
Chengdu, Sichuan, 610042
- Active, not recruiting
Fujian Provincial Cancer Hospital ( Site 3131)
Fuzhou, Fujian, 350014
- Active, not recruiting
The First Affiliated Hospital of Guangzhou Medical University ( Site 3134)
Guangzhou, Guangdong, 510140
- Active, not recruiting
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3108)
Guangzhou, Guangdong, 510515
- Active, not recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
Hangzhou, Zhejiang, 310003
- Active, not recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3111)
Hangzhou, Zhejiang, 310016
- Active, not recruiting
Harbin Medical University Cancer Hospital-oncology of department ( Site 3132)
Harbin, Heilongjiang, 150000
- Completed
Second Affiliated hospital of Anhui Medical University ( Site 3133)
Hefei, Anhui, 230000
- Active, not recruiting
Jinan Central Hospital-oncology department ( Site 3122)
Jinan, Shandong, 250013
- Active, not recruiting
Shandong Cancer Hospital ( Site 3119)
Jinan, Shandong, 250117
- Active, not recruiting
Yunnan Province Cancer Hospital ( Site 3139)
Kunming, Yunnan, 650107
- Active, not recruiting
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 3127)
Nanchang, Jiangxi, 330006
- Active, not recruiting
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3121)
Nanchang, Jiangxi, 330006
- Active, not recruiting
Jiangxi Provincial Cancer Hospital ( Site 3143)
Nanchang, Jiangxi, 330029
- Active, not recruiting
The Second People's Hospital of Neijiang ( Site 3140)
Neijiang, Sichuan, 641099
- Active, not recruiting
Shanghai Changhai Hospital ( Site 3125)
Shanghai, Shanghai Municipality, 200082
- Active, not recruiting
The Second Hospital of Hebei Medical University ( Site 3135)
Shijiazhuang, Hebei, 050000
- Active, not recruiting
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 3114)
Taizhou, Zhejiang, 317000
- Active, not recruiting
Tongji Hospital Tongji Medical,Science & Technology ( Site 3117)
Wuhan, Hubei, 430000
- Active, not recruiting
Wuhan Union Hospital ( Site 3130)
Wuhan, Hubei, 430048
- Active, not recruiting
Hubei Cancer Hospital ( Site 3106)
Wuhan, Hubei, 430079
- Active, not recruiting
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113)
Wuxi, Jiangsu, 214122
- Active, not recruiting
The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 3107)
Xiamen, Fujian, 361003
- Active, not recruiting
Xiangyang Central Hospital-oncology department ( Site 3136)
Xiangyang, Hubei, 441106
- Completed
The Affiliated Hospital of Xuzhou Medical College ( Site 3112)
Xuzhou, Jiangsu, 221002
- Completed
Affiliated Hospital of Guangdong Medical University ( Site 3123)
Zhanjiang, Guangdong, 524004
- Active, not recruiting
Henan Cancer Hospital ( Site 3116)
Zhengzhou, Henan, 450008
Japan30 sites, 28 recruiting
- Recruiting
Tokyo Metropolitan Komagome Hospital ( Site 3405)
Bunkyo, Tokyo, 113-8677
Study Coordinator, +81-3-3823-2101
- Recruiting
National Hospital Organization Kyushu Cancer Center ( Site 3417)
Fukuoka, Fukuoka, 811-1395
Study Coordinator, +81-92-541-3231
- Recruiting
National Hospital Organization Kyushu Medical Center ( Site 3416)
Fukuoka, 810-8563
Study Coordinator, +81-92-852-0700
- Recruiting
National Hospital Organization Himeji Medical Center ( Site 3426)
Himeji, Hyōgo, 670-8520
Study Coordinator, +81-79-225-3211
- Recruiting
Kansai Medical University Hospital ( Site 3412)
Hirakata, Osaka, 573-1191
Study Coordinator, +81-72-804-0101
- Active, not recruiting
Hirosaki University Hospital ( Site 3429)
Hirosaki, Aomori, 036-8563
- Recruiting
National Cancer Center Hospital East ( Site 3403)
Kashiwa, Chiba, 277-8577
Study Coordinator, +81-4-7133-1111
- Recruiting
St. Marianna University Hospital ( Site 3421)
Kawasaki, Kanagawa, 216-8511
Study Coordinator, +81-44-977-8111
- Recruiting
Cancer Institute Hospital of JFCR ( Site 3404)
Koto, Tokyo, 135-8550
Study Coordinator, +81-3-3520-0111
- Recruiting
Saiseikai Kumamoto Hospital ( Site 3419)
Kumamoto, 861-4193
Study Coordinator, +81-96-351-8000
- Recruiting
Kurume University Hospital ( Site 3418)
Kurume, Fukuoka, 830-0011
Study Coordinator, +81-942-35-3311
- Active, not recruiting
Saiseikai Matsusaka Municipal Hospital ( Site 3422)
Matsusaka, Mie-ken, 515-8544
- Recruiting
National Hospital Organization Shikoku Cancer Center ( Site 3415)
Matsuyama, Ehime, 791-0280
Study Coordinator, +81-89-999-1111
- Recruiting
Niigata Cancer Center Hospital ( Site 3409)
Niigata, Saitama, 951-8566
Study Coordinator, +81-25-266-5111
- Recruiting
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3414)
Osaka, 541-8567
Study Coordinator, +81-6-6945-1181
- Recruiting
Gunma Prefectural Cancer Center ( Site 3402)
Ōta, Gunma, 373-8550
Study Coordinator, +81-276-38-0771
- Recruiting
Toho University Omori Medical Center ( Site 3420)
Ōta-ku, Tokyo, 143-8541
Study Coordinator, +81-3-3762-4151
- Recruiting
Tohoku University Hospital ( Site 3424)
Sendai, Miyagi, 980-8574
Study Coordinator, +81-22-717-7000
- Recruiting
Sendai Kousei Hospital ( Site 3400)
Sendai, Miyagi, 981-0914
Study Coordinator, +81-22-728-8000
- Recruiting
Dokkyo Medical University Hospital ( Site 3401)
Shimotsugagun, Tochigi, 321-0293
Study Coordinator, +81-282-86-1111
- Recruiting
Tokyo Medical University Hospital ( Site 3407)
Shinjuku, Tokyo, 160-0023
Study Coordinator, +81-3-3342-6111
- Recruiting
National Center for Global Health and Medicine ( Site 3406)
Shinjuku, Tokyo, 162-8655
Study Coordinator, +81-3-3202-7181
- Recruiting
Iwate Medical University Hospital ( Site 3428)
Shiwa-gun, Iwate, 028-3695
Study Coordinator, +81-19-613-7111
- Recruiting
Shizuoka Cancer Center ( Site 3410)
Suntogun, Shizuoka, 411-8777
Study Coordinator, +81-55-989-5222
- Recruiting
Osaka Medical and Pharmaceutical University Hospital ( Site 3413)
Takatsuki, Osaka, 569-8686
Study Coordinator, +81-72-683-1221
- Recruiting
Fujita Health University Hospital ( Site 3411)
Toyoake, Aichi-ken, 470-1192
Study Coordinator, +81-562-93-2111
- Recruiting
National Hospital Organization Yamaguchi Ube Medical Center ( Site 3423)
Ube, Yamaguchi, 755-0241
Study Coordinator, +81-836-58-2300
- Recruiting
National Hospital Organization Ureshino Medical Center ( Site 3427)
Ureshino, Saga-ken, 843-0393
Study Coordinator, +81-954-43-1120
- Recruiting
Yokohama Municipal Citizen's Hospital ( Site 3425)
Yokohama, Kanagawa, 221-0855
Study Coordinator, +81-45-316-4580
- Recruiting
Kanagawa Cancer Center ( Site 3408)
Yokohama, Kanagawa, 241-8515
Study Coordinator, +81-45-520-2222
United States15 sites, 10 recruiting
- Recruiting
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)
Burbank, California, 91505
Study Coordinator, 818-840-0921
- Completed
University Hospitals Cleveland Medical Center ( Site 0119)
Cleveland, Ohio, 44106
- Recruiting
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117)
Corvallis, Oregon, 97330
Study Coordinator, 541-768-4950
- Recruiting
Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)
Grand Junction, Colorado, 81501
Study Coordinator, 970-298-7638
- Recruiting
Hattiesburg Clinic Hematology/Oncology ( Site 0104)
Hattiesburg, Mississippi, 39401
Study Coordinator, 601-261-1700
- Completed
Oncology Consultants P.A. ( Site 0129)
Houston, Texas, 77030
- Recruiting
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)
Jacksonville, Florida, 32224
Study Coordinator, 904-953-9945
- Completed
The University of Louisville, James Graham Brown Cancer Center ( Site 0121)
Louisville, Kentucky, 40202
- Completed
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106)
Marietta, Georgia, 30060
- Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)
Minneapolis, Minnesota, 55407
Study Coordinator, 651-241-7025
- Recruiting
Mayo Clinic in Arizona - Phoenix ( Site 0147)
Phoenix, Arizona, 85054
Study Coordinator, 480-342-4800
- Recruiting
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)
Reno, Nevada, 89502
Study Coordinator, 775-982-5050
- Recruiting
Mayo Clinic - Rochester ( Site 0148)
Rochester, Minnesota, 55905
Study Coordinator, 507-538-1665
- Recruiting
New England Cancer Specialists ( Site 0143)
Westbrook, Maine, 04092
Study Coordinator, 207-303-3424
- Completed
University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144)
Worcester, Massachusetts, 01655
Germany11 sites, 9 recruiting
- Recruiting
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1402)
Berlin, 13353
Study Coordinator, +4930450553044
- Recruiting
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1403)
Gera, Thuringia, 07548
Study Coordinator, 00493658287758
- Recruiting
LungenClinic Grosshansdorf-Onkologie ( Site 1401)
Großhansdorf, Schleswig-Holstein, 22927
Study Coordinator, +49 4102 6012421
- Recruiting
Medizinische Hochschule Hannover-Department of Pneumology ( Site 1411)
Hanover, Lower Saxony, 30625
Study Coordinator, 49 511 532 6553
- Recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz- Klinik für Pneumologie ( Site 1404)
Mainz, Rhineland-Palatinate, 55131
Study Coordinator, +496131177031
- Recruiting
Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 1412)
Marburg, Hesse, 35043
Study Coordinator, +4964215861819
- Recruiting
Bethanien Krankenhaus Moers ( Site 1400)
Moers, North Rhine-Westphalia, 47441
Study Coordinator, +49 2841 200 2297
- Completed
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik V ( Site 1409)
München, Bavaria, 80336
- Recruiting
Klinikum Bogenhausen-Klinik für Pneumologie und Onkologische Pneumologie ( Site 1406)
München, Bavaria, 81925
Study Coordinator, 0049892704316
- Recruiting
Universitätsklinikum Münster - Albert Schweitzer Campus-Medizinische Klinik A ( Site 1410)
Münster, North Rhine-Westphalia, 48149
Study Coordinator, +49 251 83-52712
- Completed
Klinikum Nürnberg Nord-5. Med. Klinik ( Site 1407)
Nuremberg, Bavaria, 90419
Taiwan11 sites, 8 recruiting
- Recruiting
National Taiwan University Hospital - Hsinchu branch ( Site 3901)
Hsinchu, 300
Study Coordinator, +886-972-651-703
- Completed
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3904)
Kaohsiung City, 807
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung ( Site 3902)
Kaohsiung City, 83301
Study Coordinator, 88677317123
- Recruiting
Taipei Medical University Shuang Ho Hospital ( Site 3912)
New Taipei City, 23561
Study Coordinator, +886970746943
- Completed
Taichung Veterans General Hospital-Chest ( Site 3905)
Taichung, 40705
- Recruiting
Chi Mei Hospital - Liouying Branch ( Site 3908)
Tainan, Tainan, 73657
Study Coordinator, +886963051211
- Recruiting
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3903)
Tainan, 704
Study Coordinator, 88662353535
- Recruiting
Chi Mei Medical Center ( Site 3915)
Tainan, 71004
Study Coordinator, +886980195306
- Completed
National Taiwan University Hospital-Oncology ( Site 3906)
Taipei, 10002
- Recruiting
Mackay Memorial Hospital ( Site 3909)
Taipei, 10449
Study Coordinator, +886975835146
- Recruiting
National Taiwan University Cancer Center (NTUCC) ( Site 3907)
Taipei City, Taipei, 106
Study Coordinator, +886223123456x267511
Turkey (Türkiye)11 sites, 11 recruiting
- Recruiting
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2507)
Adana, 01140
Study Coordinator, +905056166338
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2506)
Ankara, 06200
Study Coordinator, +903123360909
- Recruiting
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)
Ankara, 06230
Study Coordinator, +903123052841
- Recruiting
Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)
Ankara, 06520
Study Coordinator, +90 5067521275
- Recruiting
Ankara Bilkent Şehir Hastanesi ( Site 2500)
Ankara, 06800
Study Coordinator, +903125526000
- Recruiting
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2503)
Bornova, İzmir, 35100
Study Coordinator, 0090 232 390 43 34
- Recruiting
Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre-Oncolgyy-Hematology ( Site 2510)
Denizli, 20070
Study Coordinator, 0090 258 296 5142
- Recruiting
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
Istanbul, 34722
Study Coordinator, +902166065200
- Recruiting
Ondokuz Mayıs Universitesi ( Site 2509)
Samsun, 55139
Study Coordinator, +90 362 312 1919
- Recruiting
Medipol Mega Universite Hastanesi-oncology ( Site 2508)
Stanbul, Istanbul, 34214
Study Coordinator, +90 5325280486
- Recruiting
Erciyes University ( Site 2511)
Talas, Kayseri, 38039
Study Coordinator, +90 207 666 6270
Poland9 sites, 6 recruiting
- Recruiting
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2003)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Study Coordinator, 523743589
- Completed
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 2013)
Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300
- Recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 2015)
Krakow, Lesser Poland Voivodeship, 31-826
Study Coordinator, 12 646 82 85
- Completed
SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital ( Site 2012)
Lodz, Łódź Voivodeship, 90-549
- Recruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2018)
Olsztyn, Warmian-Masurian Voivodeship, 10-357
Study Coordinator, +48895322978
- Recruiting
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
Przemyśl, Podkarpackie Voivodeship, 37-700
Study Coordinator, 16 677 55 10
- Completed
Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2016)
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
- Recruiting
Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 2011)
Warsaw, Masovian Voivodeship, 01-138
Study Coordinator, 00 48 22 431 22 79
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
Warsaw, Masovian Voivodeship, 02-781
Study Coordinator, +48225462248
Spain9 sites, 9 recruiting
- Recruiting
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2335)
A Coruña, La Coruna, 15006
Study Coordinator, 34981178000x292872
- Recruiting
Hospital Universitari Vall d'Hebron-Oncology ( Site 2330)
Barcelona, 08035
Study Coordinator, +34932746000
- Recruiting
Hospital Jerez de la Frontera-UGC Oncología ( Site 2333)
Jerez de la Frontera, Cadiz, 11407
Study Coordinator, +3485681420
- Recruiting
Hospital La Princesa ( Site 2338)
Madrid, 28006
Study Coordinator, +34915202200
- Recruiting
H.R.U Malaga - Hospital General ( Site 2332)
Málaga, Malaga, 29011
Study Coordinator, +34 95 130 81 30
- Recruiting
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2331)
Pozuelo de Alarcón, Madrid, 28223
Study Coordinator, +34914521987
- Recruiting
Hospital Universitario Nuestra Senora de la Candelaria ( Site 2339)
Santa Cruz de Tenerife, 38010
Study Coordinator, 922602020
- Recruiting
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2337)
Seville, 41013
Study Coordinator, +34955013068
- Recruiting
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2336)
Valencia, Valenciana, Comunitat, 46009
Study Coordinator, +34961114229
France8 sites, 8 recruiting
- Recruiting
Clinique de l'Europe-Service de pneumologie ( Site 1304)
Amiens, Somme, 80000
Study Coordinator, 00 33 3 23 06 72 24
- Recruiting
Centre Hospitalier de la Cote Basque ( Site 1300)
Bayonne, Pyrenees-Atlantiques, 64109
Study Coordinator, 33559443172
- Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 1303)
Limoges, Limousin, 87042
Study Coordinator, +33555056892
- Recruiting
Hôpital Saint Joseph-ONCOLOGY ( Site 1308)
Marseille, Bouches-du-Rhone, 13008
Study Coordinator, +33491806500
- Recruiting
Institut Régional du Cancer Montpellier-Medical Oncology ( Site 1309)
Montpellier, Herault, 34298
Study Coordinator, +33467613100
- Recruiting
Centre d'Oncologie de Gentilly ( Site 1301)
Nancy, Meurthe-et-Moselle, 54000
Study Coordinator, 0033355685518
- Recruiting
Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1305)
Poitiers, Vienne, 86021
Study Coordinator, 00330516604212
- Recruiting
L HOPITAL NORD OUEST ( Site 1310)
Villefranche-sur-Saône, Rhone, 69655
Study Coordinator, +33642346915
Italy8 sites, 8 recruiting
- Recruiting
Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1804)
Bari, Apulia, 70124
Study Coordinator, +390805555442
- Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1810)
Bergamo, 24127
Study Coordinator, +390352673687
- Recruiting
AOU Renato Dulbecco ( Site 1801)
Catanzaro, 88100
Study Coordinator, +390961883221
- Recruiting
Azienda Ospedaliera Universitaria Careggi ( Site 1809)
Florence, 50134
Study Coordinator, +390557947298
- Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1807)
Meldola, Emilia-Romagna, 47014
Study Coordinator, +390543739100
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)
Milan, Lombardy, 20133
Study Coordinator, +390223903813
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1806)
Roma, 00168
Study Coordinator, +390630154844
- Recruiting
P.O. "S. Maria della Misericordia" Azienda Sanitaria Univers-Oncology Department ( Site 1803)
Udine, Friuli Venezia Giulia, 33100
Study Coordinator, +390432552751
South Korea8 sites, 6 recruiting
- Recruiting
Chungbuk National University Hospital-Internal medicine ( Site 3804)
Cheongju-si, North Chungcheong, 28644
Study Coordinator, 82-43-269-6015
- Recruiting
Keimyung University Dongsan Hospital CRC room 1 ( Site 3807)
Daegu, Taegu-Kwangyokshi, 42601
Study Coordinator, 82532586671
- Recruiting
National Cancer Center ( Site 3801)
Goyang-si, Kyonggi-do, 10408
Study Coordinator, +82319200406
- Recruiting
Asan Medical Center-Lung Cancer Center ( Site 3805)
Seoul, 05505
Study Coordinator, 02-3010-5419
- Recruiting
Samsung Medical Center-Division of Hematology/Oncology ( Site 3802)
Seoul, 06351
Study Coordinator, 82-2-3410-3453
- Recruiting
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3800)
Suwon, Kyonggi-do, 16247
Study Coordinator, 82-31-249-7744
- Completed
Ajou University Hospital-Hematology-Oncology ( Site 3806)
Suwon, Kyonggi-do, 16499
- Completed
Wonju Severance Christian Hospital ( Site 3808)
Wŏnju, Kang-won-do, 26426
Brazil6 sites, 5 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0402)
Barretos, São Paulo, 14784400
Study Coordinator, +551733216637
- Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0409)
Porto Alegre, Rio Grande do Sul, 90020-090
Study Coordinator, +55 51 3214 8151
- Recruiting
Instituto Nacional de Câncer - INCA ( Site 0405)
Rio de Janeiro, 20230-130
Study Coordinator, +552132076564
- Active, not recruiting
Clinica Viver ( Site 0400)
Santa Maria, Rio Grande do Sul, 97015-450
- Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0406)
São José do Rio Preto, São Paulo, 15090000
Study Coordinator, +551732015054
- Recruiting
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401)
São Paulo, 04014-012
Study Coordinator, +551144500300
Mexico6 sites, 5 recruiting
- Recruiting
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0715)
Guadalajara, Jalisco, 44630
Study Coordinator, 3330447001
- Recruiting
Higiea Oncologia ( Site 0721)
Mexico City, Mexico City, 11819
Study Coordinator, 5552731712
- Completed
Axis Heilsa S. de R.L. de C.V. ( Site 0719)
Monterrey, Nuevo León, 64060
- Recruiting
Oaxaca Site Management Organization S.C. ( Site 0718)
Oaxaca City, 68000
Study Coordinator, +529511301554
- Recruiting
Clinica Integral Internacional de Oncología ( Site 0714)
Puebla City, 72530
Study Coordinator, +522223555576
- Recruiting
Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0713)
San Luis Potosí City, San Luis Potosí, 78200
Study Coordinator, +52 444 585 2263
Peru6 sites, 6 recruiting
- Recruiting
Clinica Vallesur - AUNA ( Site 0854)
Arequipa, Ariqipa, 15036
Study Coordinator, +51 926 938 398
- Recruiting
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0851)
Lima, 15036
Study Coordinator, +51 956754968
- Recruiting
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0850)
Lima, 15038
Study Coordinator, +51940238282
- Recruiting
Instituto Neuro Cardiovascular de las Americas ( Site 0856)
Lima, 15047
Study Coordinator, +51991366612
- Recruiting
Hospital Cayetano Heredia-Oncology ( Site 0855)
Lima, Lima 31
Study Coordinator, +51 986981097
- Recruiting
Detecta Clínica ( Site 0853)
Surquillo, Muni Metro de Lima, 15038
Study Coordinator, +51992783190
Vietnam6 sites
- Active, not recruiting
K Hospital - National Cancer Hospital ( Site 4174)
Hà Nội, 100000
- Active, not recruiting
National Lung Hospital-Oncology Department ( Site 4175)
Hanoi, Hanoi, 100000
- Active, not recruiting
Tam Anh General Hospital ( Site 4179)
Hanoi, Hanoi, 100000
- Active, not recruiting
Cho Ray Hospital ( Site 4171)
Ho Chi Minh, Hanoi, 700000
- Active, not recruiting
Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 4173)
Ho Chi Minh City, 700000
- Active, not recruiting
Thong Nhat Hospital ( Site 4170)
Ho Chi Minh City, 700000
Argentina5 sites, 5 recruiting
- Recruiting
Hospital Británico de Buenos Aires-Oncology ( Site 0304)
Buenos Aires, Buenos Aires F.D., C1280AEB
Study Coordinator, +541143096807
- Recruiting
Hospital Aleman-Oncology ( Site 0300)
Buenos Aires, C1118AAT
Study Coordinator, +541148277000
- Recruiting
Instituto Alexander Fleming ( Site 0306)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Study Coordinator, +54 9 011-3221-8900
- Recruiting
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)
Río Cuarto, Córdoba Province, X5800ALB
Study Coordinator, +54351153819050
- Recruiting
Instituto de Oncología de Rosario ( Site 0301)
Rosario, Santa Fe Province, S2000KZE
Study Coordinator, +549-341-5778394
Australia5 sites, 4 recruiting
- Completed
Grampians Health-Medical Oncology ( Site 3001)
Ballarat Central, Victoria, 3350
- Recruiting
Northern Hospital ( Site 3003)
Epping, Victoria, 3076
Study Coordinator, +61384058715
- Recruiting
Peninsula University Hospital ( Site 3004)
Frankston, Victoria, 3199
Study Coordinator, +61397847175
- Recruiting
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002)
Port Macquarie, New South Wales, 2444
Study Coordinator, +61265801820
- Recruiting
Westmead Hospital ( Site 3000)
Westmead, New South Wales, 2145
Study Coordinator, +61247343500
Chile5 sites, 5 recruiting
- Recruiting
Bradford Hill Norte ( Site 0516)
Antofagasta, 1263521
Study Coordinator, 56442023631
- Recruiting
Orlandi Oncologia-Oncology ( Site 0504)
Santiago, Region M. de Santiago, 7500713
Study Coordinator, 56226057491
- Recruiting
FALP-UIDO ( Site 0509)
Santiago, Region M. de Santiago, 7500921
Study Coordinator, 56224205098
- Recruiting
Bradfordhill-Clinical Area ( Site 0507)
Santiago, Region M. de Santiago, 8420383
Study Coordinator, 56229490970
- Recruiting
Clinica Universidad Catolica del Maule-Oncology ( Site 0501)
Talca, Maule Region, 3465584
Study Coordinator, 56947532700
Portugal5 sites, 4 recruiting
- Recruiting
Hospital Dr. Nélio Mendonça ( Site 2105)
Funchal, Madeira, 9004-514
Study Coordinator, +351291705600
- Recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 2104)
Lisbon, Lisbon District, 1099-023
Study Coordinator, 00351217229800
- Recruiting
Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2101)
Lisbon, Lisbon District, 1769-001
Study Coordinator, 00351217805000
- Recruiting
Hospital CUF - Tejo ( Site 2100)
Lisbon, 1350-352
Study Coordinator, +351213926100
- Completed
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 2103)
Vila Nova de Gaia, Porto District, 4434-502
United Kingdom5 sites, 2 recruiting
- Recruiting
Kent and Canterbury Hospital-Oncology Research ( Site 2606)
Canterbury, Kent, CT1 3NG
Study Coordinator, 01227 866393
- Active, not recruiting
James Cook University Hospital ( Site 2604)
Central Middlesbrough, Middlesbrough, TS4 3BW
- Active, not recruiting
Royal Free Hospital ( Site 2601)
London, England, NW3 2QG
- Active, not recruiting
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2605)
London, London, City of, SE1 9RT
- Recruiting
Queen Alexandra Hospital-Oncology Department ( Site 2603)
Portsmouth, Hampshire, PO6 3LY
Study Coordinator, 023 9228 6000 x4078
Czechia4 sites, 4 recruiting
- Recruiting
Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102)
Olomouc, 779 00
Study Coordinator, +420 588 443 666
- Recruiting
Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1103)
Ostrava, Ostrava Mesto, 703 00
Study Coordinator, +420 595 633 400
- Recruiting
Multiscan-Onkologicke a radiologicke centrum Multiscan Pardubice ( Site 1105)
Pardubice, Pardubice Region, 532 03
Study Coordinator, +420466016436
- Recruiting
Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1106)
Prague, Praha 2, 128 08
Study Coordinator, +420224962143
Canada3 sites, 2 recruiting
- Recruiting
William Osler Health System ( Site 0203)
Brampton, Ontario, L6R 3J7
Study Coordinator, 905-494-2120
- Recruiting
Trillium Health Partners - Credit Valley Hospital ( Site 0202)
Mississauga, Ontario, L5M 2N1
Study Coordinator, 905-813-1100x4299
- Completed
McGill University Health Centre ( Site 0200)
Montreal, Quebec, H4A 3J1
Colombia3 sites, 3 recruiting
- Recruiting
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)
Bogotá, Bogota D.C., 110131
Study Coordinator, 3219198898
- Recruiting
IMAT S.A.S ( Site 0602)
Montería, Departamento de Córdoba, 230002
Study Coordinator, +57 (3135342052)
- Recruiting
Oncologos del Occidente ( Site 0603)
Pereira, Risaralda Department, 660001
Study Coordinator, 573002558656
Denmark3 sites, 3 recruiting
- Recruiting
Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1201)
Aalborg, North Denmark, 9000
Study Coordinator, +45 97660000
- Recruiting
Regionshospitalet Gødstrup-Kræftklinikken ( Site 1204)
Herning, Central Jutland, 7400
Study Coordinator, +45 78430453
- Recruiting
Odense Universitetshospital ( Site 1200)
Odense C, Region Syddanmark, 5000
Study Coordinator, +4523612809
Netherlands3 sites, 3 recruiting
- Recruiting
Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 1901)
Breda, North Brabant, 4818 CK
Study Coordinator, 0031765955349
- Recruiting
ETZ Elisabeth-Department of Pulmonary Diseases ( Site 1902)
Tilburg, North Brabant, 5022 GC
Study Coordinator, 0031132213101
- Recruiting
Isala, locatie Zwolle-Poli Longziekten ( Site 1903)
Zwolle, Overijssel, 8025 AB
Study Coordinator, 0031886243254
Thailand3 sites, 3 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital ( Site 4000)
Bangkok, Bangkok, 10700
Study Coordinator, +6624194489
- Recruiting
Maharaj Nakorn Chiang Mai Hospital ( Site 4001)
Muang, Chiang Mai, 50200
Study Coordinator, +6653935480
- Recruiting
Chulalongkorn University ( Site 4003)
Pathumwan, Bangkok, 10330
Study Coordinator, +6622564533
About this study
Official title: A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Sacituzumab tirumotecan, Pembrolizumab, Supportive care measures
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab tirumotecanBiological
Also called SKB264, MK-2870
IV infusion
PembrolizumabBiological
Also called MK-3475, KEYTRUDA®, SCH 900475
IV infusion
Supportive care measuresDrug
Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Sacituzumab tirumotecan | Experimental | Participants receive sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator. Receives: Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab; Drug: Supportive care measures |
| Pembrolizumab | Active comparator | Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles Receives: Biological: Pembrolizumab; Drug: Supportive care measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: Up to approximately 49 months
Secondary outcomes (13)
Progression free survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first
Measured: Up to approximately 49 months
Objective Response (OR)
The OR is defined as a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR.
Measured: Up to approximately 49 months
Duration of Response (DOR)
For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 49 months
Change from Baseline in Global Health Status/Quality of Life (QOL) [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) 29 Items and 30] Score
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Measured: Baseline and up to approximately 77 months
Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Measured: Baseline and up to approximately 77 months
Change From Baseline in Cough (EORTC QLQ-LC13 Item 31) Score
Change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Measured: Baseline and up to approximately 77 months
Change From Baseline in Chest Pain (EORTC QLQ-LC13 item 40) Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
Measured: Baseline and up to approximately 77 months
Time to Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Item 29 and 30)
The TTD in GHS/QOL score (EORTC QLQ-C30 Items 29 and 30) will be presented. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD as assessed based on a negative change (decrease in score) from Baseline in GHS/QOL score. A longer TTD indicates a better outcome.
Measured: Up to approximately 77 months
Time to Deterioration (TTD) Based on Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
The TTD in Dyspnea score (EORTC QLQ-C30 Item 8) will be presented. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
Measured: Up to approximately 77 months
Time to Deterioration (TTD) Based on Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31).
The TTD in Cough score (EORTC QLQ-LC13 Item 31) will be presented. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
Measured: Up to approximately 77 months
Time to Deterioration (TTD) Based on Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)
The TTD in Chest Pain score (EORTC QLQ-LC13 Item 40) will be presented. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
Measured: Up to approximately 77 months
Percentage of Participants That Experience at Least 1 Adverse Event
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience an AE will be presented.
Measured: Up to approximately 77 months
Percentage of Participants Who Discontinue Study Treatment Due to an AE
The percentage of participants who discontinue study treatment due to an AE will be presented.
Measured: Up to approximately 77 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start15 Dec 2023
- Primary completion25 Jan 2028 (estimated)
- Study completion27 May 2030 (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 Cancer (NSCLC)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 614 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
- NCT06170788
- Sponsor's protocol ID
- 2870-007
- Other IDs
- MK-2870-007, 2023-503376-24-00, jRCT2051240089, U1111-1287-1395, 2023
- Acronym
- TroFuse-007
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2023
- 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