A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed… (NCT06203210) | Clinical Trial Compass
RecruitingPhase 3
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
United States, Australia, Austria540 participantsStarted 2024-05-21
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Exclusion criteria
. Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial measuring overall survival — does that mean there's enough earlier data on ifinatamab deruxtecan's safety and effectiveness that it's worth considering over other options available to me right now?
2The trial compares ifinatamab deruxtecan against 'treatment of physician's choice' — what treatments would likely fall into that physician's choice arm, and how do they compare to what you'd normally recommend for me at this stage of my small cell lung cancer?
3Since this trial is for relapsed small cell lung cancer, can you help me understand where I am in my treatment journey and whether my specific relapse situation — like how long after first-line treatment I relapsed — would even make this trial worth discussing further?
4Randomized trials like this one mean I might not receive the experimental drug — how would you manage my care if I were assigned to the control arm, and would I have access to ifinatamab deruxtecan afterward if it proved beneficial?
5What does participation in this trial actually look like day-to-day in terms of visits, monitoring, and travel, and do you think the demands of being in a Phase 3 study are realistic given my current health and situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival (OS)
Timeframe: From the date of randomization to the date of death due to any cause, up to approximately 3.7 years
Trial details
NCT IDNCT06203210
SponsorDaiichi Sankyo
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-01-30
Contact for this trial
Daiichi Sankyo Contact for Clinical Trial Information
. 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 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: