Sacituzumab Tirumotecan and Pembrolizumab for Lung Cancer
This study is for people with metastatic non-small cell lung cancer (NSCLC), which means the cancer has spread. It's comparing two treatments: sacituzumab tirumotecan combined with pembrolizumab, versus pembrolizumab alone. Pembrolizumab is an immunotherapy that helps your immune system fight cancer. The study wants to see if adding sacituzumab tirumotecan improves how long people live (overall survival). To join, you need a confirmed diagnosis of NSCLC, and your tumor must show a certain level of PD-L1 (a protein that can help cancer cells hide from the immune system). Your cancer also shouldn't be treatable with certain other therapies (EGFR-, ALK-, or ROS1-directed therapy). The study plans to enroll 614 participants, but its current status is unclear.
- Study design
- This is an interventional study comparing two treatment groups. It aims to enroll 614 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for overall survival for up to approximately 49 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06170788
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
PHASE3Ages 18+InterventionalTreatmentMerck Sharp & Dohme LLC
~614 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanPembrolizumabSupportive care measures
At a glance
Recruiting sites
166 of 220 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Up to approximately 49 months
Conditions
Where it's being run
220 sites across 143 statesTaiwan9
Turkey (Türkiye)8
Tokyo5
Hubei4
Italy4
Peru4
Spain4
Victoria3
Study leadership
- Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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 trial measures
- Overall Survival (OS)Up to approximately 49 months
OS is defined as the time from randomization to death from any cause.