NCT06203210Recruiting
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Summary
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).
Inclusion criteria
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.
Exclusion criteria
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
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, Australia, Belgium, Brazil, Canada, China, Czechia, Greece, Hungary, Japan, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Taiwan, Turkey (Türkiye)
- Sponsor
- Daiichi Sankyo(Industry)
- Protocol no.
- DS7300-188
- Conditions
- Small Cell Lung Cancer
- Interventions
- Drug
Treatments studied
- Ifinatamab deruxtecan
- Topotecan
- Amrubicin
- Lurbinectedin
Collaborators
Merck Sharp & Dohme LLC
Locations · 189
- Bern, SwitzerlandInselspital - Universitaetsspital BernRecruiting at this site
- Sankt Gallen, SwitzerlandKantonsspital St. GallenRecruiting at this site
- Villars-sur-Glâne, SwitzerlandHfr Fribourg/Kantonsspital FribourgRecruiting at this site
- Avignon, FranceInstitut Sainte CatherineRecruiting at this site
- Créteil, FranceCentre Hospitalier Intercommunal de CrăteilRecruiting at this site
- Lille, FranceInstitut Cœur Poumon CHU de LilleRecruiting at this site
- Limoges, FranceChu Limoges - Hopital Du CluzeauRecruiting at this site
- Marseille, FranceAssistance Publique-Hăpitaux de MarseilleRecruiting at this site
- Montpellier, FranceHopital Arnaud de VilleneuveRecruiting at this site
- Montpellier, FranceInstitut Régional Du Cancer de MontpellierRecruiting at this site
- Mulhouse, FranceCh de Mulhouse - Hăpital Emile MullerRecruiting at this site
- Paris, FranceInstitut Curie - Site de ParisRecruiting at this site
- Paris, FranceHopital TenonRecruiting at this site
- Rennes, FranceChu Rennes - Hopital PontchaillouRecruiting at this site
- Saint-Etienne, FranceCHU de Saint EtienneRecruiting at this site
- Saint-Priest-en-Jarez, FranceInstitut de Cancerologie de La LoireRecruiting at this site
- Berlin, GermanyEvangelische Lungenklinik BerlinRecruiting at this site
- Erfurt, GermanyHelios Klinikum ErfurtRecruiting at this site
- Essen, GermanyUniverstitaetsklinikum EssenRecruiting at this site
- Frankfurt, GermanyKrankenhaus Nordwest GmbhRecruiting at this site
- Frankfurt am Main, GermanyUniversitaetsklinikum Frankfurt Goethe-UniversitaetRecruiting at this site
- Gauting, GermanyAsklepios Fachkliniken Muenchen-GautingRecruiting at this site
- Gera, GermanySrh Wald-Klinikum Gera GmbhRecruiting at this site
- Giessen, GermanyUNIVERSITATSKLINIKUM GIeBEN UND MARBURG GMBHRecruiting at this site
- Immenhausen, GermanyLki Lungenfachklinik ImmenhausenRecruiting at this site
- Kiel, GermanyStaedtisches Krankenhaus KielRecruiting at this site
- Bari, ItalyIstituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico BariRecruiting at this site
- Bergamo, ItalyHumanitas GavazzeniRecruiting at this site
- Catanzaro, ItalyAzienda Ospedaliero Universitaria Renato DulbeccoRecruiting at this site
- Genova, ItalyIstituto Nazionale Per La Ricerca Sul Cancro Di GenovaRecruiting at this site
In total, worldwide, 189 of the 229 sites listed in the registry are recruiting; the other 40 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: August 6, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 159 more locations
Other identifiers
- 2023-509628-16-00 · CTIS number
- 2031230631 · other identifier
- 2023 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.