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)
Launched by MERCK SHARP & DOHME LLC · Dec 6, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for patients with metastatic non-small cell lung cancer (NSCLC), specifically those whose tumors have a high level of a protein called PD-L1. The trial compares a combination of two medications, sacituzumab tirumotecan and pembrolizumab, against pembrolizumab alone to see which option helps patients live longer. The researchers want to find out if adding sacituzumab tirumotecan improves overall survival rates for patients.
To be eligible for this trial, participants must have a confirmed diagnosis of squamous or nonsquamous NSCLC and a PD-L1 score of 50% or higher in their tumor tissue. They should be in generally good health, with a life expectancy of at least three months, and not have received prior treatment for their metastatic lung cancer. If someone joins the study and completes the initial treatment with pembrolizumab, they may have the option to continue with additional cycles of this medication if their disease shows signs of worsening. The trial is currently recruiting participants and welcomes individuals of all genders aged 65 and older.
Gender
ALL
Eligibility 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 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.
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported