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Combining sacituzumab tirumotecan with pembrolizumab for advanced lung cancer

A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)

PHASE3 · Merck Sharp & Dohme LLC · NCT06170788

This study is testing if combining two cancer treatments, sacituzumab tirumotecan and pembrolizumab, can help people with advanced lung cancer live longer compared to just using pembrolizumab alone.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment614 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC (industry)
Drugs / interventionssacituzumab, pembrolizumab, radiation
Locations218 sites (Phoenix, Arizona and 217 other locations)
Trial IDNCT06170788 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of sacituzumab tirumotecan in combination with pembrolizumab compared to pembrolizumab alone in patients with metastatic non-small cell lung cancer (NSCLC) that expresses PD-L1 in 50% or more of tumor cells. The primary focus is on overall survival, with participants receiving up to 10 cycles of treatment based on their response. Eligible patients must have a confirmed diagnosis of NSCLC and meet specific criteria regarding prior therapies and performance status.

Who should consider this trial

Good fit: Ideal candidates include individuals with confirmed metastatic NSCLC and high PD-L1 expression who have not responded to other targeted therapies.

Not a fit: Patients with small cell lung cancer or those with severe peripheral neuropathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could significantly improve survival rates for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy combinations, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Phoenix, Arizona and 217 other locations

+168 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer, Programmed Cell Death-1, Programmed Cell Death 1 Ligand 1, Programmed Cell Death 1 Ligand 2

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.