Pembrolizumab with or without Sacituzumab Tirumotecan for NSCLC
This study is looking at adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that can be removed by surgery. It's for people whose cancer didn't completely disappear after initial treatment. Researchers want to see if adding sacituzumab tirumotecan to pembrolizumab after surgery works better than pembrolizumab alone to prevent the cancer from returning. Pembrolizumab and sacituzumab tirumotecan are given through an IV. Some participants will also receive standard chemotherapy like cisplatin, pemetrexed, or gemcitabine before surgery. The study aims to measure how long people live without their disease coming back. You would need to have specific types of NSCLC, including certain stages and nodal involvement, to be eligible.
- Study design
- This is an interventional study with a planned enrollment of 780 participants. It compares two treatment approaches for non-small cell lung cancer.
- What's involved
- Sacituzumab tirumotecan is given every two weeks for up to 24 weeks, and pembrolizumab is given every six weeks for up to 42 weeks. Background chemotherapy treatments are given every three weeks for up to 12 or 24 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for up to approximately 93 months to assess how long they live without their disease returning.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06312137
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)
Recruiting
PHASE3Ages 18+InterventionalTreatmentMerck Sharp & Dohme LLC
~780 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanPembrolizumabCisplatinPemetrexedGemcitabineCarboplatin
At a glance
Recruiting sites
257 of 268 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)
Measured over Up to ~ 93 months
Conditions
Where it's being run
268 sites across 154 statesJapan9
California7
Georgia7
Italy7
Turkey (Türkiye)7
Zhejiang5
Peru5
Romania5
Study leadership
- Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement \[N2\]) per AJCC eighth edition guidelines
Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy
Is able to undergo surgery based on opinion of investigator after consultation with surgeon
Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy
Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period
Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention
Exclusion
Has one of the following tumor locations/types:
NSCLC involving the superior sulcus
Large cell neuro-endocrine cancer (LCNEC)
Sarcomatoid tumor
Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
Has Grade ≥2 peripheral neuropathy
Has 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 history of inflammatory bowel disease
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
Has received prior neoadjuvant therapy for their current NSCLC diagnosis
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening
Has an active infection requiring systemic therapy
Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
Has a history of allogeneic tissue/solid organ transplant
Has not adequately recovered from major surgery or have ongoing surgical complications
Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and/or to another biologic therapy
What this trial measures
- Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)Up to ~ 93 months
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.