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Looking for participantsPhase3

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06170788

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sacituzumab tirumotecan (biological), Pembrolizumab (biological), Supportive care measures (drug)
How long the study runs
Study runs about 77 months (dates as stated)
About the drug or intervention
Sacituzumab tirumotecan — biological: IV infusion · Pembrolizumab — biological: IV infusion · Supportive care measures — drug: Participants are allowed to take supportive care measures at the discretion of the investigator.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
614
Started
2023-12-15
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer (nsclc)
  • • Phase3 - 614 participants
  • • The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-small cell lung cancer (nsclc)

Where?

  • • London - Royal Free Hospital ( Site 2601)
  • • Portsmouth - Queen Alexandra Hospital-Oncology Department ( Site 2603)
  • • Canterbury - Kent and Canterbury Hospital-Oncology Research ( Site 2606)
  • • London - Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2605)
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Non-small Cell Lung Cancer (NSCLC)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

EGFRALKROS1PD-L1

Treatment history

Treatments you must have had:

  • ✓ well controlled HIV on antiretroviral therapy (ART)

What the study is looking for

  • ✓confirmed by testing a sample diagnosis of squamous or nonsquamous NSCLC
  • ✓Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as...
  • ✓An activity scale (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
  • ✓A expected to live at least 3 $2.
  • ✓Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Who cannot take part

  • ✗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...
  • ✗Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of...
  • ✗Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study...
See the full 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.

Where Is This Study? (5 UK sites)

Royal Free Hospital ( Site 2601)

London NW3 2QG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0207 794 0500

Queen Alexandra Hospital-Oncology Department ( Site 2603)

Portsmouth PO6 3LY, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator023 9228 6000 x4078

Kent and Canterbury Hospital-Oncology Research ( Site 2606)

Canterbury CT1 3NG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01227 866393

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2605)

London SE1 9RT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0207 188 2006

James Cook University Hospital ( Site 2604)

Central Middlesbrough TS4 3BW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4401642837193

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09