An EAP Treatment Protocol of Zipalertinib (NCT07601399) | Clinical Trial Compass
AVAILABLENot Applicable
An EAP Treatment Protocol of Zipalertinib
Plain-language summary
"Only licensed physicians may submit an email inquiry/question about Taiho's Zipalertinib Expanded Access Program via email (Zipalertinib@parexel.com). If you are a patient or caregiver, do not email Parexel or Taiho. Please talk to your physician. Do not share any patient Personally Identifiable Information with Parexel."
The objective of the study is to provide access to zipalertinib to patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy with or without amivantamab.
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
. Has provided written informed consent.
. Has histologically confirmed, locally advanced, metastatic, or recurrent unresectable NSCLC with EGFR ex20ins mutations based on testing performed by a qualified (CLIA certified) laboratory.
Exclusion criteria
. Has a history and/or current evidence of any of the following:
. History of congestive heart failure Class III/IV according to the New York Heart Association Functional Classification
. Serious cardiac arrhythmias requiring treatment
. Has not recovered from side effects of the following prior therapies:
. Has a serious illness or medical condition(s) that in the judgment of the treating physician would make the patient inappropriate for entry into this program.
. Has a history of another primary malignancy whose natural history or treatment has the potential to interfere with the safety assessment of zipalertinib in the opinion of the treating physician.
. Has known hypersensitivity to the ingredients in zipalertinib or any drugs similar in structure or class.
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 described as an Expanded Access Program for zipalertinib rather than a standard clinical trial — can you explain what that means for my situation, and whether it suggests this drug isn't yet fully approved or proven safe and effective for my type of non-small cell lung cancer?
2Since expanded access programs are typically offered when other treatment options have been exhausted or aren't suitable, do you think I've reached that point, or are there standard approved treatments I should try first before considering this pathway?
3What do you know about zipalertinib's safety profile so far — what side effects have been reported in the studies that led to this expanded access program being available?
4Would my specific non-small cell lung cancer subtype, stage, or any genetic mutations I have make me a better or worse candidate for zipalertinib, based on what's known from earlier research on this drug?
5If I were to pursue this expanded access program, what would the practical demands look like — how often would I need to come in, how would I get the drug, and who would monitor me for any problems along the way?
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.