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 now · Phase 3

Conditions studied: Non-small Cell Lung Cancer (NSCLC)

In brief

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. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

Key facts

Study ID

NCT06170788

Run by

Merck Sharp & Dohme LLC

People needed

614

Starts

2023-12-15

Expected to finish

2030-05-27

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

• Clinica Viver ( Site 0400) — Santa Maria, Rio Grande do Sul, Brazil (enrolling)
• Instituto Nacional de Câncer - INCA ( Site 0405) — Rio de Janeiro, Brazil (enrolling)
• Mayo Clinic in Arizona - Phoenix ( Site 0147) — Phoenix, Arizona, United States (enrolling)
• Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0409) — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0402) — Barretos, São Paulo, Brazil (enrolling)
• Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0406) — São José do Rio Preto, São Paulo, Brazil (enrolling)
• Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133) — Jacksonville, Florida, United States (enrolling)
• Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115) — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic - Rochester ( Site 0148) — Rochester, Minnesota, United States (enrolling)
• Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130) — Burbank, California, United States (enrolling)
• Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134) — Reno, Nevada, United States (enrolling)
• Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132) — Grand Junction, Colorado, United States (enrolling)
• Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117) — Corvallis, Oregon, United States (enrolling)
• New England Cancer Specialists ( Site 0143) — Westbrook, Maine, United States (enrolling)
• Instituto Alexander Fleming ( Site 0306) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Hospital Británico de Buenos Aires-Oncology ( Site 0304) — Buenos Aires, Buenos Aires F.D., Argentina (enrolling)
• Centro Privado de RMI Río Cuarto S.A. II ( Site 0310) — Río Cuarto, Córdoba Province, Argentina (enrolling)
• Instituto de Oncología de Rosario ( Site 0301) — Rosario, Santa Fe Province, Argentina (enrolling)
• Hospital Aleman-Oncology ( Site 0300) — Buenos Aires, Argentina (enrolling)
• Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002) — Port Macquarie, New South Wales, Australia (enrolling)
• Westmead Hospital ( Site 3000) — Westmead, New South Wales, Australia (enrolling)
• Hattiesburg Clinic Hematology/Oncology ( Site 0104) — Hattiesburg, Mississippi, United States (enrolling)
• Northern Hospital ( Site 3003) — Epping, Victoria, Australia (enrolling)
• Peninsula University Hospital ( Site 3004) — Frankston, Victoria, Australia (enrolling)
• Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401) — São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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