Who may be eligible for this metastatic non-small cell lung cancer clinical trial?

Adults aged 18 or older with confirmed squamous or nonsquamous non-small cell lung cancer and high PD-L1 expression (50% or more) may be eligible. Participants must not have received prior systemic treatment for metastatic disease and should have a good performance status. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic non-small cell lung cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06170788

A Randomized, Open-label Phase 3 Study of Sacituzumab Tirumotecan Combined With Pembrolizumab Compared to Pembrolizumab Alone in First-line Treatment of Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50

Q: What is sacituzumab tirumotecan studying for metastatic non-small cell lung cancer?

Sacituzumab tirumotecan is being studied together with pembrolizumab to see if this combination improves overall survival compared to pembrolizumab alone in adults with metastatic non-small cell lung cancer. The trial aims to find better treatment options for patients whose tumors have high PD-L1 expression. It is sponsored by Merck Sharp & Dohme LLC.

Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08

614

Participants Needed

219

Research Sites

121 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the combination of sacituzumab tirumotecan and pembrolizumab compared to pembrolizumab alone in adults with metastatic non-small cell lung cancer NSCLC whose tumors have high PD-L1 expression 50 or greater. The study aims to determine if adding sacituzumab tirumotecan improves overall survival compared to pembrolizumab by itself. This is a phase 3, randomized, open-label trial sponsored by Merck Sharp Dohme LLC. Participants in the experimental group receive sacituzumab tirumotecan through intravenous infusion on Days 1, 15, and 29 of each 6-week cycle, along with pembrolizumab 400 mg IV every 6 weeks for up to 18 cycles. Pre-medications such as diphenhydramine, an H2 antagonist, acetaminophen, and dexamethasone are given before the first 4 sacituzumab tirumotecan infusions. The control group receives pembrolizumab 400 mg IV every 6 weeks for up to 18 cycles. Supportive care measures are allowed as needed. Throughout the study, participants undergo regular assessments including tumor evaluations using RECIST 1.1 criteria, quality of life questionnaires, and monitoring for adverse events. The primary outcome is overall survival measured for up to approximately 49 months. Secondary outcomes include progression-free survival, response rates, symptom changes, and treatment tolerability over up to 77 months. Participants may continue pembrolizumab monotherapy for up to 9 additional cycles if disease progression is confirmed after initial treatment.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
Tumor tissue shows PD-L1 expression in 50% or more of tumor cells
No indication for EGFR-, ALK-, or ROS1-directed primary therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 7 days before randomization
Life expectancy of at least 3 months
If HIV-infected, must have well-controlled HIV on antiretroviral therapy

You will not qualify if you...

Diagnosis of small cell lung cancer or presence of small cell elements in mixed tumors
Grade 2 or higher peripheral neuropathy
Severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or severe corneal disease delaying healing
Active inflammatory bowel disease requiring immunosuppressive medication or history of such diseases
Uncontrolled significant cardiovascular or cerebrovascular disease within 6 months before study
Prior systemic anticancer therapy for metastatic NSCLC
Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents except certain neoadjuvant or adjuvant settings
Systemic anticancer therapy including investigational agents within 4 weeks before randomization
Radiation to lung >30 Gy within 6 months or radiation within 2 weeks before study
Live or live-attenuated vaccine within 30 days before first dose
Diagnosis of immunodeficiency or chronic systemic steroid therapy
Active malignancy requiring treatment within past 3 years
Known active CNS metastases or carcinomatous meningitis
Known intolerance or severe hypersensitivity to study drugs
Active autoimmune disease needing systemic treatment in past 2 years
History or presence of pneumonitis or interstitial lung disease requiring steroids
Active infection needing systemic therapy
Concurrent active Hepatitis B and C infection
HIV with history of Kaposi's sarcoma or Multicentric Castleman's Disease
History of allogeneic tissue or solid organ transplant
Treatment with strong CYP3A4 inhibitors or inducers within 14 days before first dose and during study

Research Team

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