Actively Recruiting
A Phase 3 Study of Pembrolizumab With or Without Sacituzumab Tirumotecan in Adults With Resectable Stage II to IIIB NSCLC Not Achieving Complete Response After Neoadjuvant Therapy and Surgery
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-22
780
Participants Needed
264
Research Sites
34 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves outcomes for adults with resectable non-small cell lung cancer NSCLC who did not achieve a complete response from initial treatment. This Phase 3 study compares combined sacituzumab tirumotecan plus pembrolizumab therapy to pembrolizumab alone to see which better supports disease-free survival. The trial focuses on participants with stage II to IIIB NSCLC who have undergone neoadjuvant pembrolizumab and platinum-based chemotherapy followed by surgery. Participants first receive pembrolizumab intravenously every 3 weeks with double-platinum chemotherapy for up to 12 weeks before surgery. After surgery, one group receives sacituzumab tirumotecan infusions every 2 weeks for up to 24 weeks alongside pembrolizumab infusions every 6 weeks for about 42 weeks. The comparison group receives pembrolizumab alone every 6 weeks for up to 7 cycles post-surgery. Rescue medications may be given to manage infusion reactions or mouth sores as needed. During the study, participants undergo regular evaluations including imaging scans to confirm disease status and laboratory tests to monitor health. Researchers assess disease-free survival as the primary outcome over up to about 93 months, alongside secondary measures such as overall survival, metastasis-free survival, lung cancer-specific survival, adverse events, and quality of life changes over up to 118 months. The study includes careful safety monitoring and long-term follow-up to understand treatment effects and participant wellbeing.
CONDITIONS
Brief Title
A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of resectable squamous or nonsquamous NSCLC stage II, IIIA, or IIIB with nodal involvement (N2) per AJCC eighth edition
- No indication for EGFR-directed or ALK-directed therapy as primary treatment
- Able to undergo surgery as determined by investigator and surgeon
- Able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy
- Did not achieve pathological complete response at surgery
- Provided tumor tissue sample for PD-L1 and TROP2 status before adjuvant randomization
- Confirmed disease-free status by radiological assessment within 28 days before randomization
- Recovered to Grade 1 or baseline from adverse events of previous anticancer therapies
- HIV-infected participants must have well controlled HIV on antiretroviral therapy
- Hepatitis B surface antigen positive participants must have received antiviral therapy for at least 4 weeks with undetectable viral load
- Participants with history of hepatitis C must have undetectable viral load at least 4 weeks before intervention
You will not qualify if you...
- Tumor located in superior sulcus or diagnosis of large cell neuro-endocrine cancer, sarcomatoid tumor, or small cell lung cancer elements
- Grade 2 or higher peripheral neuropathy
- Severe dry eye syndrome, Meibomian gland disease, blepharitis, or corneal disease delaying healing
- Active inflammatory bowel disease requiring immunosuppressive medication or history of such disease
- Uncontrolled significant cardiovascular or cerebrovascular disease within 6 months before study
- Prior neoadjuvant therapy for current NSCLC diagnosis
- Prior systemic anticancer therapy or investigational agents within 4 weeks before study intervention
- Prior radiotherapy within 2 weeks before study or radiation-related toxicities needing corticosteroids
- Live or live-attenuated vaccine within 30 days before study intervention
- Immunodeficiency diagnosis or systemic steroid/immunosuppressive therapy exceeding specified doses within 7 days before first dose
- Active malignancy progressing or treated within past 5 years
- Active autoimmune disease requiring systemic treatment within past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Concurrent active hepatitis B and C infection
- History of allogeneic tissue or solid organ transplant
- Not recovered from major surgery or ongoing surgical complications
- Severe hypersensitivity (Grade 3 or higher) to study treatments or biologics
Research Team
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