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)
Recruiting · NCT06170788 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 14 US states.
- Mayo Clinic in Arizona - Phoenix ( Site 0147) - Phoenix, Arizona, United States
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130) - Burbank, California, United States
- Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132) - Grand Junction, Colorado, United States
- Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133) - Jacksonville, Florida, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106) - Marietta, Georgia, United States
- The University of Louisville, James Graham Brown Cancer Center ( Site 0121) - Louisville, Kentucky, United States
- New England Cancer Specialists ( Site 0143) - Westbrook, Maine, United States
- University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144) - Worcester, Massachusetts, United States
- Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115) - Minneapolis, Minnesota, United States
- Mayo Clinic - Rochester ( Site 0148) - Rochester, Minnesota, United States
- Hattiesburg Clinic Hematology/Oncology ( Site 0104) - Hattiesburg, Mississippi, United States
- Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134) - Reno, Nevada, United States
- University Hospitals Cleveland Medical Center ( Site 0119) - Cleveland, Ohio, United States
- Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117) - Corvallis, Oregon, United States
- Oncology Consultants P.A. ( Site 0129) - Houston, Texas, United States
- Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2507) - Adana, Turkey (Türkiye)
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2506) - Ankara, Turkey (Türkiye)
- Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501) - Ankara, Turkey (Türkiye)
- Memorial Ankara Hastanesi-Medical Oncology ( Site 2505) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi ( Site 2500) - Ankara, Turkey (Türkiye)
- Bradford Hill Norte ( Site 0516) - Antofagasta, Chile
- Hospital Universitari Vall d'Hebron-Oncology ( Site 2330) - Barcelona, Spain
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1810) - Bergamo, Italy
- Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1402) - Berlin, Germany
- Hospital Aleman-Oncology ( Site 0300) - Buenos Aires, Argentina
- AOU Renato Dulbecco ( Site 1801) - Catanzaro, Italy
- Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 4001) - Chiang Mai, Thailand
- Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre-Oncolgyy-Hematology ( Site 2510) - Denizli, Turkey (Türkiye)
- Azienda Ospedaliera Universitaria Careggi ( Site 1809) - Florence, Italy
- National Hospital Organization Kyushu Medical Center ( Site 3416) - Fukuoka, Japan
- Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 4173) - Ho Chi Minh City, Vietnam
- Thong Nhat Hospital ( Site 4170) - Ho Chi Minh City, Vietnam
- National Taiwan University Hospital - Hsinchu branch ( Site 3901) - Hsinchu, Taiwan
- K Hospital - National Cancer Hospital ( Site 4174) - Hà Nội, Vietnam
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502) - Istanbul, Turkey (Türkiye)
- Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3904) - Kaohsiung City, Taiwan
- Chang Gung Memorial Hospital at Kaohsiung ( Site 3902) - Kaohsiung City, Taiwan
- Saiseikai Kumamoto Hospital ( Site 3419) - Kumamoto, Japan
- IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0851) - Lima, Peru
- INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0850) - Lima, Peru
- Instituto Neuro Cardiovascular de las Americas ( Site 0856) - Lima, Peru
- Hospital Cayetano Heredia-Oncology ( Site 0855) - Lima, Peru
- Hospital CUF - Tejo ( Site 2100) - Lisbon, Portugal
- Hospital La Princesa ( Site 2338) - Madrid, Spain
- Taipei Medical University Shuang Ho Hospital ( Site 3912) - New Taipei City, Taiwan
- Oaxaca Site Management Organization S.C. ( Site 0718) - Oaxaca City, Mexico
- Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102) - Olomouc, Czechia
- Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3414) - Osaka, Japan
- Clinica Integral Internacional de Oncología ( Site 0714) - Puebla City, Mexico
- Instituto Nacional de Câncer - INCA ( Site 0405) - Rio de Janeiro, Brazil
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1806) - Roma, Italy
- Ondokuz Mayıs Universitesi ( Site 2509) - Samsun, Turkey (Türkiye)
- Hospital Universitario Nuestra Senora de la Candelaria ( Site 2339) - Santa Cruz de Tenerife, Spain
- Asan Medical Center-Lung Cancer Center ( Site 3805) - Seoul, South Korea
- Samsung Medical Center-Division of Hematology/Oncology ( Site 3802) - Seoul, South Korea
- HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2337) - Seville, Spain
- Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401) - São Paulo, Brazil
- Taichung Veterans General Hospital-Chest ( Site 3905) - Taichung, Taiwan
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 3903) - Tainan, Taiwan
- Chi Mei Medical Center ( Site 3915) - Tainan, Taiwan
Showing 60 of 220 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →