Tests ifinatamab deruxtecan against standard drugs in relapsed small cell lung cancer
Compares ifinatamab deruxtecan with physician's choice treatment in adults with returning small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Key facts
- Where
- Liberec I-Stare Mesto, Olomouc, and Prague, CzechiaSee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Has your cancer come back or got worse during or after treatment with platinum chemotherapy?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT06203210, who can take part
Where in Czechia
- Krajska nemocnice Liberec a.s.Liberec I-Stare Mesto, CzechiaTaking people
- University Hospital OlomoucOlomouc, CzechiaTaking people
- Fakultni Thomayerova nemocnicePrague, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Daiichi Sankyo
- Trial code
- NCT06203210EU 2023-509628-16-00
- Record updated
- 6 August 2026
- Original description
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).Read full original descriptionShow less
A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)
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: Participants must meet all the following criteria to be eligible for randomization into the study:; Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures; Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed; Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC); The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content; 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; Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator; Has documentation of radiological disease progression on or after the most recent systemic therapy; Has ECOG PS of less than or equal to (≤)1 within 7 days prior to Cycle 1 Day 1 (C1D1); Participants with brain metastasis/leptomeningeal disease are eligible if protocol specified criteria are met.
Exclusion: Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd; Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities; Has received any of the comparators used in this study or any topoisomerase I inhibitor; Has inadequate washout period before randomization as specified in the protocol; 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; Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event; Has uncontrolled or significant cardiovascular (CV) disease; Has clinically significant corneal disease; All of the following indicators of interstitial lung disease (ILD)/pneumonitis are excluded:; Any history of ILD/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids; Current diagnosis of ILD; 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; Participants who meet any of the following criteria will be disqualified from entering the study:.