NCT06203210Recrutement en cours
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Résumé
This study is designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
Critères d'inclusion
Participants must meet all the following criteria to be eligible for randomization into the study: 1. Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures. 2. Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed. 3. Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC). 4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content. 5. Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy free-interval \[CTFI\] (duration from stop date of the platinum agent in 1L therapy to radiological PD) of ≥30 days. 6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator. 7. Has documentation of radiological disease progression on or after the most recent systemic therapy. 8. Has ECOG PS of less than or equal to (≤)1 within 7 days prior to Cycle 1 Day 1 (C1D1). 9. Participants with brain metastasis/leptomeningeal disease are eligible if protocol specified criteria are met.
Critères d'exclusion
Participants who meet any of the following criteria will be disqualified from entering the study: 1. Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd. 2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities. 3. Has received any of the comparators used in this study or any topoisomerase I inhibitor. 4. Has inadequate washout period before randomization as specified in the protocol. 5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event. 6. Has uncontrolled or significant cardiovascular (CV) disease. 7. Has clinically significant corneal disease. 8. All of the following indicators of interstitial lung disease (ILD)/pneumonitis are excluded: 1. Any history of ILD/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids. 2. Current diagnosis of ILD. 3. Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out. Radiographic findings may include presence of lung parenchymal fibrosis, combined fibrosis and emphysema (CPFE), and/or interstitial lung abnormalities such as reticular opacities, traction bronchiectasis, honeycombing, or extensive ground glass opacities. Screening computed tomography (CT) scans must be submitted for independent central radiology review and results before randomization. 9. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.
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, Australie, Belgique, Brésil, Canada, Chine, Tchéquie, Grèce, Hongrie, Japon, Pays-Bas, Pologne, Portugal, Roumanie, Corée du Sud, Espagne, Taïwan, Turquie
- Promoteur
- Daiichi Sankyo(Industrie)
- N° de protocole
- DS7300-188
- Pathologies
- Small Cell Lung Cancer
- Interventions
- Médicament
Traitements évalués
- Ifinatamab deruxtecan
- Topotecan
- Amrubicin
- Lurbinectedin
Collaborateurs
Merck Sharp & Dohme LLC
Lieux · 189
- Bern, SuisseInselspital - Universitaetsspital BernRecrute dans ce centre
- Sankt Gallen, SuisseKantonsspital St. GallenRecrute dans ce centre
- Villars-sur-Glâne, SuisseHfr Fribourg/Kantonsspital FribourgRecrute dans ce centre
- Avignon, FranceInstitut Sainte CatherineRecrute dans ce centre
- Créteil, FranceCentre Hospitalier Intercommunal de CrăteilRecrute dans ce centre
- Lille, FranceInstitut Cœur Poumon CHU de LilleRecrute dans ce centre
- Limoges, FranceChu Limoges - Hopital Du CluzeauRecrute dans ce centre
- Marseille, FranceAssistance Publique-Hăpitaux de MarseilleRecrute dans ce centre
- Montpellier, FranceHopital Arnaud de VilleneuveRecrute dans ce centre
- Montpellier, FranceInstitut Régional Du Cancer de MontpellierRecrute dans ce centre
- Mulhouse, FranceCh de Mulhouse - Hăpital Emile MullerRecrute dans ce centre
- Paris, FranceInstitut Curie - Site de ParisRecrute dans ce centre
- Paris, FranceHopital TenonRecrute dans ce centre
- Rennes, FranceChu Rennes - Hopital PontchaillouRecrute dans ce centre
- Saint-Etienne, FranceCHU de Saint EtienneRecrute dans ce centre
- Saint-Priest-en-Jarez, FranceInstitut de Cancerologie de La LoireRecrute dans ce centre
- Berlin, AllemagneEvangelische Lungenklinik BerlinRecrute dans ce centre
- Erfurt, AllemagneHelios Klinikum ErfurtRecrute dans ce centre
- Essen, AllemagneUniverstitaetsklinikum EssenRecrute dans ce centre
- Frankfurt, AllemagneKrankenhaus Nordwest GmbhRecrute dans ce centre
- Frankfurt am Main, AllemagneUniversitaetsklinikum Frankfurt Goethe-UniversitaetRecrute dans ce centre
- Gauting, AllemagneAsklepios Fachkliniken Muenchen-GautingRecrute dans ce centre
- Gera, AllemagneSrh Wald-Klinikum Gera GmbhRecrute dans ce centre
- Giessen, AllemagneUNIVERSITATSKLINIKUM GIeBEN UND MARBURG GMBHRecrute dans ce centre
- Immenhausen, AllemagneLki Lungenfachklinik ImmenhausenRecrute dans ce centre
- Kiel, AllemagneStaedtisches Krankenhaus KielRecrute dans ce centre
- Bari, ItalieIstituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico BariRecrute dans ce centre
- Bergamo, ItalieHumanitas GavazzeniRecrute dans ce centre
- Catanzaro, ItalieAzienda Ospedaliero Universitaria Renato DulbeccoRecrute dans ce centre
- Genova, ItalieIstituto Nazionale Per La Ricerca Sul Cancro Di GenovaRecrute dans ce centre
Au total, dans le monde, 189 des 229 centres listés au registre recrutent ; les 40 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 6 août 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 159 autres lieux
Autres identifiants
- 2023-509628-16-00 · n° CTIS
- 2031230631 · 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.