Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lun… (NCT07535359) | Clinical Trial Compass
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Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer
United States
Plain-language summary
The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to I-DXd for eligible patients with extensive-stage small cell lung cancer (ES-SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen), and for eligible patients who have no suitable treatment options and are not able to enter a clinical study.
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.
Exclusion criteria
. cerebrovascular accident, or
. transient ischemic attack, or
. another arterial thromboembolic event.
. Type I diabetes mellitus, hypothyroidism only requiring hormone replacement
. Skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or
. Conditions not expected to recur in the absence of an external trigger.
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 program is described as a 'medical access program' rather than a standard clinical trial phase — what does that mean for how ifinatamab deruxtecan would be provided to me, and is this different from enrolling in a formal research study?
2Since this is for patients who have already gone through at least three prior lines of treatment, can you walk me through whether my specific treatment history actually fits what this program requires?
3Ifinatamab deruxtecan is an antibody-drug conjugate, a type of targeted therapy — what side effects have been reported with this drug class in small cell lung cancer patients, and how would you monitor and manage them if I were to access it through this program?
4Given that this is an access program rather than a phase with full efficacy data, how confident are you in what's currently known about how well this drug works in extensive-stage small cell lung cancer at this point in treatment?
5Are there any other standard-of-care options or ongoing clinical trials I should weigh against this access program before we decide whether pursuing ifinatamab deruxtecan through this route makes the most sense for my 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.