RecruitingPhase 3

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)

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding sacituzumab tirumotecan (MK-2870) to pembrolizumab helps people live longer than pembrolizumab alone. It is for people with non-small cell lung cancer that has spread to other parts of the body and has the PD-L1 protein on at least half of its tumor cells.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-small cell lung cancer confirmed by testing tissue or cells.
  • Do not need treatment targeting EGFR, ALK, or ROS1 gene changes as the first treatment.
  • Provide a tumor sample that a central lab confirms has PD-L1 on at least 50% of its cells.
  • Be fully active or able to do light work, as checked within 7 days before assignment to a study group.
  • Be expected to live at least 3 months.
  • If you have HIV, it must be well controlled with HIV medicines.

Who can't join

  • Have any small cell lung cancer, moderate or worse nerve damage outside the brain and spinal cord, or certain severe eye problems.
  • Have a history of inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis, or serious uncontrolled heart or brain blood vessel disease within the past 6 months.
  • Have had whole-body cancer treatment for lung cancer that has spread, or any whole-body cancer treatment within 4 weeks before group assignment. Prior treatment with certain immune drugs also excludes you, with a limited exception for treatment around surgery completed at least 12 months before the cancer spread.
  • Have had lung radiation over 30 Gy within 6 months, any radiation within 2 weeks, or radiation side effects needing steroids. A live vaccine within 30 days before the first study dose also excludes you.
  • Have a weak immune system, take long-term whole-body steroids, or have an autoimmune disease needing whole-body treatment in the past 2 years. Current lung inflammation, or past noninfectious lung inflammation needing steroids, also excludes you.
  • Have another cancer that is growing or needed treatment in the past 3 years, active cancer spread to the brain or spinal cord, or cancer in the lining around them.
  • Have an infection needing whole-body treatment, both active hepatitis B and C, or HIV with a history of Kaposi’s sarcoma or Multicentric Castleman’s disease.
  • Have certain allergies or intolerance to the study drugs or other biologic treatments, a past tissue or organ transplant from a donor, or need medicines that strongly affect the liver enzyme CYP3A4 during the specified study period.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (15)

AZ

CA

  • Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130) · Burbank, CA 91505Study Coordinator · Study contact · 818-840-0921More trials in Burbank

CO

FL

GA

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106) · Marietta, GA 30060More trials in Marietta

KY

MA

  • University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144) · Worcester, MA 01655More trials in Worcester

ME

MN

MS

NV

  • Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134) · Reno, NV 89502Study Coordinator · Study contact · 775-982-5050More trials in Reno

OH

OR

  • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117) · Corvallis, OR 97330Study Coordinator · Study contact · 541-768-4950More trials in Corvallis

TX