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 now · Phase 3

Conditions studied: Non Small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT06312137

Run by

Merck Sharp & Dohme LLC

People needed

780

Starts

2024-04-03

Expected to finish

2034-10-23

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical University of South Carolina-Hollings Cancer Center ( Site 0045) — Charleston, South Carolina, United States (enrolling)
• Avera Cancer Institute- Research ( Site 0090) — Sioux Falls, South Dakota, United States (enrolling)
• University of Tennessee Medical Center Knoxville ( Site 0082) — Knoxville, Tennessee, United States (enrolling)
• Sanford Cancer Center ( Site 0053) — Sioux Falls, South Dakota, United States (enrolling)
• Huntsman Cancer Institute ( Site 0042) — Salt Lake City, Utah, United States (enrolling)
• Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Hospital Británico de Buenos Aires-Oncology ( Site 0207) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Sanatorio Británico-Clinical Oncology Department ( Site 0206) — Rosario, Santa Fe Province, Argentina (enrolling)
• Sanatorio Parque ( Site 0205) — Rosario, Santa Fe Province, Argentina (enrolling)
• Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 0217) — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• Hospital Aleman-Oncology ( Site 0202) — Buenos Aires, Argentina (enrolling)
• Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204) — Córdoba, Argentina (enrolling)
• Westmead Hospital ( Site 0701) — Westmead, New South Wales, Australia (enrolling)
• The Prince Charles Hospital ( Site 0700) — Brisbane, Queensland, Australia (enrolling)
• Fiona Stanley Hospital-Medical Oncology ( Site 0705) — Murdoch, Western Australia, Australia (enrolling)
• Medizinische Universitaet Innsbruck-Department for Internal Medicine V ( Site 1403) — Innsbruck, Tyrol, Austria (enrolling)
• Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 1402) — Linz, Upper Austria, Austria (enrolling)
• Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 1401) — Vienna, Austria (enrolling)
• Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1400) — Vienna, Austria (enrolling)
• Antwerp University Hospital-Thoracic Oncology ( Site 1503) — Edegem, Antwerpen, Belgium (enrolling)
• Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 1502) — Yvoir, Namur, Belgium (enrolling)
• VITAZ ( Site 1500) — Sint-Niklaas, Oost-Vlaanderen, Belgium (enrolling)
• Liga Norte Riograndense Contra o Câncer ( Site 0301) — Natal, Rio Grande do Norte, Brazil (enrolling)
• Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0303) — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Hospital Nossa Senhora da Conceição ( Site 0302) — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)

Full record on ClinicalTrials.gov

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