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 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)
- Non-small Cell Lung Cancer (NSCLC)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 614
- Started
- 15 December 2023
- Main results due
- 25 January 2028
- Study sites
- 220
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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. * 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(220)
Mayo Clinic in Arizona - Phoenix ( Site 0147)
Phoenix, Arizona, United States
Recruiting
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)
Burbank, California, United States
Recruiting
Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)
Grand Junction, Colorado, United States
Recruiting
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)
Jacksonville, Florida, United States
Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106)
Marietta, Georgia, United States
Completed
The University of Louisville, James Graham Brown Cancer Center ( Site 0121)
Louisville, Kentucky, United States
Completed
New England Cancer Specialists ( Site 0143)
Westbrook, Maine, United States
Recruiting
University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144)
Worcester, Massachusetts, United States
Completed
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)
Minneapolis, Minnesota, United States
Recruiting
Mayo Clinic - Rochester ( Site 0148)
Rochester, Minnesota, United States
Recruiting
Hattiesburg Clinic Hematology/Oncology ( Site 0104)
Hattiesburg, Mississippi, United States
Recruiting
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)
Reno, Nevada, United States
Recruiting
University Hospitals Cleveland Medical Center ( Site 0119)
Cleveland, Ohio, United States
Completed
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117)
Corvallis, Oregon, United States
Recruiting
Oncology Consultants P.A. ( Site 0129)
Houston, Texas, United States
Completed
Instituto Alexander Fleming ( Site 0306)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Hospital Británico de Buenos Aires-Oncology ( Site 0304)
Buenos Aires, Buenos Aires F.D., Argentina
Recruiting
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)
Río Cuarto, Córdoba Province, Argentina
Recruiting
Instituto de Oncología de Rosario ( Site 0301)
Rosario, Santa Fe Province, Argentina
Recruiting
Hospital Aleman-Oncology ( Site 0300)
Buenos Aires, Argentina
Recruiting
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002)
Port Macquarie, New South Wales, Australia
Recruiting
Westmead Hospital ( Site 3000)
Westmead, New South Wales, Australia
Recruiting
Grampians Health-Medical Oncology ( Site 3001)
Ballarat Central, Victoria, Australia
Completed
Northern Hospital ( Site 3003)
Epping, Victoria, Australia
Recruiting
Peninsula University Hospital ( Site 3004)
Frankston, Victoria, Australia
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0409)
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Clinica Viver ( Site 0400)
Santa Maria, Rio Grande do Sul, Brazil
Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0402)
Barretos, São Paulo, Brazil
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0406)
São José do Rio Preto, São Paulo, Brazil
Recruiting
Instituto Nacional de Câncer - INCA ( Site 0405)
Rio de Janeiro, Brazil
Recruiting
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401)
São Paulo, Brazil
Recruiting
William Osler Health System ( Site 0203)
Brampton, Ontario, Canada
Recruiting
Trillium Health Partners - Credit Valley Hospital ( Site 0202)
Mississauga, Ontario, Canada
Recruiting
McGill University Health Centre ( Site 0200)
Montreal, Quebec, Canada
Completed
Clinica Universidad Catolica del Maule-Oncology ( Site 0501)
Talca, Maule Region, Chile
Recruiting
Orlandi Oncologia-Oncology ( Site 0504)
Santiago, Region M. de Santiago, Chile
Recruiting
FALP-UIDO ( Site 0509)
Santiago, Region M. de Santiago, Chile
Recruiting
Bradfordhill-Clinical Area ( Site 0507)
Santiago, Region M. de Santiago, Chile
Recruiting
Bradford Hill Norte ( Site 0516)
Antofagasta, Chile
Recruiting
Second Affiliated hospital of Anhui Medical University ( Site 3133)
Hefei, Anhui, China
Completed
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 3101)
Beijing, Beijing Municipality, China
Active, not recruiting
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100)
Beijing, Beijing Municipality, China
Active, not recruiting
Fujian Provincial Cancer Hospital ( Site 3131)
Fuzhou, Fujian, China
Active, not recruiting
The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 3107)
Xiamen, Fujian, China
Active, not recruiting
The First Affiliated Hospital of Guangzhou Medical University ( Site 3134)
Guangzhou, Guangdong, China
Active, not recruiting
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3108)
Guangzhou, Guangdong, China
Active, not recruiting
Affiliated Hospital of Guangdong Medical University ( Site 3123)
Zhanjiang, Guangdong, China
Completed
The Second Hospital of Hebei Medical University ( Site 3135)
Shijiazhuang, Hebei, China
Active, not recruiting
Harbin Medical University Cancer Hospital-oncology of department ( Site 3132)
Harbin, Heilongjiang, China
Active, not recruiting
Henan Cancer Hospital ( Site 3116)
Zhengzhou, Henan, China
Active, not recruiting
Tongji Hospital Tongji Medical,Science & Technology ( Site 3117)
Wuhan, Hubei, China
Active, not recruiting
Wuhan Union Hospital ( Site 3130)
Wuhan, Hubei, China
Active, not recruiting
Hubei Cancer Hospital ( Site 3106)
Wuhan, Hubei, China
Active, not recruiting
Xiangyang Central Hospital-oncology department ( Site 3136)
Xiangyang, Hubei, China
Active, not recruiting
The Second Xiangya Hospital of Central South University ( Site 3138)
Changsha, Hunan, China
Active, not recruiting
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113)
Wuxi, Jiangsu, China
Active, not recruiting
The Affiliated Hospital of Xuzhou Medical College ( Site 3112)
Xuzhou, Jiangsu, China
Completed
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 3127)
Nanchang, Jiangxi, China
Active, not recruiting
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3121)
Nanchang, Jiangxi, China
Active, not recruiting
Jiangxi Provincial Cancer Hospital ( Site 3143)
Nanchang, Jiangxi, China
Active, not recruiting
Showing 60 of 220 sites — filter to narrow it down. 162 of the 220 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06170788. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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