NCT06312137Recrutement en cours
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)
Résumé
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).
Critères d'inclusion
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
Critères d'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
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 3
- Type d'étude
- Interventionnelle
- Pays
- Suisse, France, Allemagne, Italie, Autriche, États-Unis, Argentine, Australie, Belgique, Brésil, Canada, Chili, Chine, Tchéquie, Grèce, Hong Kong, Israël, Japon, Mexique, Pays-Bas, Nouvelle-Zélande, Norvège, Pérou, Pologne, Portugal, Roumanie, Corée du Sud, Espagne, Taïwan, Turquie, Royaume-Uni
- Promoteur
- Merck Sharp & Dohme LLC(Industrie)
- N° de protocole
- 2870-019
- Pathologies
- Non Small Cell Lung Cancer
- Interventions
- Biologique, Médicament
Traitements évalués
- Sacituzumab tirumotecan
- Pembrolizumab
- Cisplatin
- Pemetrexed
- Gemcitabine
- Carboplatin
- Paclitaxel
- Rescue medication
Lieux · 258
- Lausanne, SuisseCHUV (centre hospitalier universitaire vaudois) ( Site 3003)Recrute dans ce centre
- Chur, SuisseKantonsspital Graubünden-Medizin ( Site 3006)Recrute dans ce centre
- Münsterlingen, SuisseKantonsspital Münsterlingen - Spital Thurgau AG ( Site 3005)Recrute dans ce centre
- Fribourg, SuisseHFR Fribourg - Hôpital Cantonal ( Site 3004)Recrute dans ce centre
- Brest, FranceCHRU de Brest ( Site 1804)Recrute dans ce centre
- Toulouse, FranceCHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1801)Recrute dans ce centre
- Rouen, FranceCHU Charles Nicolle ( Site 1803)Recrute dans ce centre
- Limoges, FranceCentre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1805)Recrute dans ce centre
- Valenciennes, FranceClinique Teissier Groupe ( Site 1811)Recrute dans ce centre
- Clermont-Ferrand, FranceCentre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1810)Recrute dans ce centre
- Bron, FranceHospices Civils de Lyon - Hopital Louis Pradel ( Site 1809)Recrute dans ce centre
- Toulon, FranceHIA Sainte Anne ( Site 1800)Recrute dans ce centre
- Paris, FranceHôpital Tenon ( Site 1802)Recrute dans ce centre
- Paris, FranceGroupe hospitalier Paris saint Joseph. ( Site 1807)Recrute dans ce centre
- Esslingen am Neckar, AllemagneKlinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1914)Recrute dans ce centre
- Regensburg, AllemagneUniversitaetsklinikum Regensburg ( Site 1907)Recrute dans ce centre
- Hemer, AllemagneLungenklinik Hemer ( Site 1905)Recrute dans ce centre
- Koblenz, AllemagneKatholisches Klinikum Koblenz ( Site 1911)Recrute dans ce centre
- Leipzig, AllemagneUniversitätsklinikum Leipzig ( Site 1915)Recrute dans ce centre
- Halle, AllemagneKrankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 1908)Recrute dans ce centre
- Bad Berka, AllemagneZentralklinik Bad Berka-Klinik für Hämatologie und Onkologie ( Site 1902)Recrute dans ce centre
- Gera, AllemagneSRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1900)Recrute dans ce centre
- Berlin, AllemagneEvangelische Lungenklinik Berlin-Pneumologie ( Site 1904)Recrute dans ce centre
- Berlin, AllemagneCharité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1903)Recrute dans ce centre
- Berlin, AllemagneVivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- ( Site 1912)Recrute dans ce centre
- Berlin, AllemagneHelios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1916)Recrute dans ce centre
- Misterbianco, ItalieHumanitas Istituto Clinico Catanese ( Site 2315)Recrute dans ce centre
- Meldola, ItalieIRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 2302)Recrute dans ce centre
- Milan, ItalieFondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 2300)Recrute dans ce centre
- Milan, ItalieSan Paolo - ASST SANTI PAOLO E CARLO ( Site 2314)Recrute dans ce centre
Au total, dans le monde, 258 des 270 centres listés au registre recrutent ; les 12 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 15 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 228 autres lieux
Autres identifiants
- 2023-508012-35-00 · autre registre
- MK-2870-019 · autre identifiant
- jRCT2021240020 · autre registre
- U1111-1297-4260 · autre identifiant
- 2023 · financement NIH
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.