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)

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSacituzumab tirumotecan and Pembrolizumab

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 27, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 3

Interventional

Where is it offered?220 U.S. locations

Locations may change over time.

Who runs it?Merck Sharp & Dohme LLC

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Merck Sharp & Dohme LLC
Interventions being studied: Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab; Drug: Supportive care measures

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→Supportive or behavioral care→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Mayo Clinic in Arizona - Phoenix ( Site 0147)Phoenix, Arizona
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)Burbank, California
Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)Grand Junction, Colorado
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)Jacksonville, Florida
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106)Marietta, Georgia
The University of Louisville, James Graham Brown Cancer Center ( Site 0121)Louisville, Kentucky
New England Cancer Specialists ( Site 0143)Westbrook, Maine
University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144)Worcester, Massachusetts
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)Minneapolis, Minnesota
Mayo Clinic - Rochester ( Site 0148)Rochester, Minnesota
Hattiesburg Clinic Hematology/Oncology ( Site 0104)Hattiesburg, Mississippi
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)Reno, Nevada

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 27, 2026. Always confirm current availability with the study team.

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