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)
A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
- Non Small Cell Lung Cancer
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 780
- Started
- 3 April 2024
- Main results due
- 21 February 2034
- Study sites
- 270
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * 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 Criteria: * 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 study is about
In the sponsor’s own words, from the registry.
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
Study sites(270)
UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)
Little Rock, Arkansas, United States
Recruiting
Highlands Oncology Group-Research Department ( Site 0062)
Springdale, Arkansas, United States
Recruiting
Beverly Hills Cancer Center ( Site 0070)
Beverly Hills, California, United States
Recruiting
The Angeles Clinic and Research Institute ( Site 0040)
Los Angeles, California, United States
Completed
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)
Los Angeles, California, United States
Completed
UCLA Clinical & Translational Research Center (CTRC) ( Site 0033)
Los Angeles, California, United States
Recruiting
Hoag Memorial Hospital Presbyterian ( Site 0096)
Newport Beach, California, United States
Recruiting
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 4002)
Orange, California, United States
Recruiting
San Francisco Oncology Associates ( Site 0066)
San Francisco, California, United States
Recruiting
Stamford Hospital ( Site 0083)
Stamford, Connecticut, United States
Recruiting
Mayo Clinic in Florida ( Site 0014)
Jacksonville, Florida, United States
Recruiting
Mount Sinai Cancer Center ( Site 0038)
Miami Beach, Florida, United States
Recruiting
Mid Florida Hematology and Oncology Center ( Site 0018)
Orange City, Florida, United States
Recruiting
Piedmont Atlanta Hospital ( Site 4000)
Atlanta, Georgia, United States
Recruiting
Emory University School of Medicine-Phase I ( Site 0056)
Atlanta, Georgia, United States
Recruiting
Northside Hospital ( Site 0055)
Atlanta, Georgia, United States
Recruiting
Centricity Research Columbus Cancer Center ( Site 0005)
Columbus, Georgia, United States
Completed
Southeastern Regional Medical Center ( Site 0065)
Newnan, Georgia, United States
Recruiting
Lewis Cancer and Research Pavilion ( Site 0063)
Savannah, Georgia, United States
Recruiting
Archbold Cancer Center ( Site 0071)
Thomasville, Georgia, United States
Recruiting
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017)
Elmhurst, Illinois, United States
Completed
North Shore University Health System ( Site 4014)
Evanston, Illinois, United States
Recruiting
Accellacare of Duly ( Site 4005)
Lisle, Illinois, United States
Recruiting
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078)
Naperville, Illinois, United States
Completed
Parkview Research Center at Parkview Regional Medical Center ( Site 0089)
Fort Wayne, Indiana, United States
Recruiting
Indiana University Health Arnett Cancer Center ( Site 0076)
Lafayette, Indiana, United States
Recruiting
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061)
Edgewood, Kentucky, United States
Recruiting
LSU Health Baton Rouge North Clinic ( Site 4003)
Baton Rouge, Louisiana, United States
Recruiting
Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080)
Baton Rouge, Louisiana, United States
Recruiting
New England Cancer Specialists ( Site 0095)
Westbrook, Maine, United States
Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)
Minneapolis, Minnesota, United States
Recruiting
Mayo Clinic - Rochester ( Site 0073)
Rochester, Minnesota, United States
Recruiting
Mercy South - David M Sindelar Cancer Center ( Site 0098)
St Louis, Missouri, United States
Recruiting
Mercy Research - David C. Pratt Cancer Center ( Site 0006)
St Louis, Missouri, United States
Recruiting
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)
Reno, Nevada, United States
Recruiting
Atlantic Health Morristown Medical Center ( Site 0077)
Morristown, New Jersey, United States
Recruiting
Cayuga Medical Center ( Site 0086)
Ithaca, New York, United States
Recruiting
University Hospital at Stony Brook ( Site 0054)
Stony Brook, New York, United States
Recruiting
White Plains Hospital ( Site 0091)
White Plains, New York, United States
Recruiting
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057)
Fargo, North Dakota, United States
Recruiting
Hightower Clinical, LLC ( Site 0084)
Oklahoma City, Oklahoma, United States
Recruiting
Oregon Health and Science University ( Site 0052)
Portland, Oregon, United States
Recruiting
Penn State Milton S. Hershey Medical Center-Penn State Cancer Institute ( Site 0059)
Hershey, Pennsylvania, United States
Recruiting
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068)
Lancaster, Pennsylvania, United States
Recruiting
Saint Joseph's Candler Health System ( Site 4010)
Bluffton, South Carolina, United States
Recruiting
Medical University of South Carolina-Hollings Cancer Center ( Site 0045)
Charleston, South Carolina, United States
Recruiting
Sanford Cancer Center ( Site 0053)
Sioux Falls, South Dakota, United States
Recruiting
Avera Cancer Institute- Research ( Site 0090)
Sioux Falls, South Dakota, United States
Recruiting
University of Tennessee Medical Center Knoxville ( Site 0082)
Knoxville, Tennessee, United States
Recruiting
Millennium Research & Clinical Development ( Site 0039)
Houston, Texas, United States
Completed
Huntsman Cancer Institute ( Site 0042)
Salt Lake City, Utah, United States
Recruiting
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Hospital Británico de Buenos Aires-Oncology ( Site 0207)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Sanatorio Británico-Clinical Oncology Department ( Site 0206)
Rosario, Santa Fe Province, Argentina
Recruiting
Sanatorio Parque ( Site 0205)
Rosario, Santa Fe Province, Argentina
Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 0217)
San Miguel de Tucumán, Tucumán Province, Argentina
Recruiting
Hospital Aleman-Oncology ( Site 0202)
Buenos Aires, Argentina
Recruiting
Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204)
Córdoba, Argentina
Recruiting
Westmead Hospital ( Site 0701)
Westmead, New South Wales, Australia
Recruiting
The Prince Charles Hospital ( Site 0700)
Brisbane, Queensland, Australia
Recruiting
Showing 60 of 270 sites — filter to narrow it down. 258 of the 270 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06312137. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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