NCT06312137Recruiting

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)

Summary

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).

Inclusion criteria

The key inclusion and exclusion criteria include but are not limited to the following: • 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

Contacts

The trial team's contact details are shown on request.

See the official trial record

Status: Recruiting
Phase: Phase 3
Study type: Interventional
Countries: Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Greece, Hong Kong, Israel, Japan, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Sponsor: Merck Sharp & Dohme LLC(Industry)
Protocol no.: 2870-019
Conditions: Non Small Cell Lung Cancer
Interventions: Biological, Drug

Treatments studied

Sacituzumab tirumotecan
Pembrolizumab
Cisplatin
Pemetrexed
Gemcitabine
Carboplatin
Paclitaxel
Rescue medication

Locations · 258

Lausanne, SwitzerlandCHUV (centre hospitalier universitaire vaudois) ( Site 3003)Recruiting at this site
Chur, SwitzerlandKantonsspital Graubünden-Medizin ( Site 3006)Recruiting at this site
Münsterlingen, SwitzerlandKantonsspital Münsterlingen - Spital Thurgau AG ( Site 3005)Recruiting at this site
Fribourg, SwitzerlandHFR Fribourg - Hôpital Cantonal ( Site 3004)Recruiting at this site
Brest, FranceCHRU de Brest ( Site 1804)Recruiting at this site
Toulouse, FranceCHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1801)Recruiting at this site
Rouen, FranceCHU Charles Nicolle ( Site 1803)Recruiting at this site
Limoges, FranceCentre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1805)Recruiting at this site
Valenciennes, FranceClinique Teissier Groupe ( Site 1811)Recruiting at this site
Clermont-Ferrand, FranceCentre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1810)Recruiting at this site
Bron, FranceHospices Civils de Lyon - Hopital Louis Pradel ( Site 1809)Recruiting at this site
Toulon, FranceHIA Sainte Anne ( Site 1800)Recruiting at this site
Paris, FranceHôpital Tenon ( Site 1802)Recruiting at this site
Paris, FranceGroupe hospitalier Paris saint Joseph. ( Site 1807)Recruiting at this site
Esslingen am Neckar, GermanyKlinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1914)Recruiting at this site
Regensburg, GermanyUniversitaetsklinikum Regensburg ( Site 1907)Recruiting at this site
Hemer, GermanyLungenklinik Hemer ( Site 1905)Recruiting at this site
Koblenz, GermanyKatholisches Klinikum Koblenz ( Site 1911)Recruiting at this site
Leipzig, GermanyUniversitätsklinikum Leipzig ( Site 1915)Recruiting at this site
Halle, GermanyKrankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 1908)Recruiting at this site
Bad Berka, GermanyZentralklinik Bad Berka-Klinik für Hämatologie und Onkologie ( Site 1902)Recruiting at this site
Gera, GermanySRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1900)Recruiting at this site
Berlin, GermanyEvangelische Lungenklinik Berlin-Pneumologie ( Site 1904)Recruiting at this site
Berlin, GermanyCharité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1903)Recruiting at this site
Berlin, GermanyVivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- ( Site 1912)Recruiting at this site
Berlin, GermanyHelios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1916)Recruiting at this site
Misterbianco, ItalyHumanitas Istituto Clinico Catanese ( Site 2315)Recruiting at this site
Meldola, ItalyIRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 2302)Recruiting at this site
Milan, ItalyFondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 2300)Recruiting at this site
Milan, ItalySan Paolo - ASST SANTI PAOLO E CARLO ( Site 2314)Recruiting at this site

In total, worldwide, 258 of the 270 sites listed in the registry are recruiting; the other 12 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 15, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 228 more locations

Other identifiers

2023-508012-35-00 · other registry
MK-2870-019 · other identifier
jRCT2021240020 · other registry
U1111-1297-4260 · other identifier
2023 · NIH grant

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.