An EAP Treatment Protocol of Zipalertinib
ConditionNon-Small Cell Lung Cancer
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorTaiho Oncology, Inc.
About this trial
"Only licensed physicians may submit an email inquiry/question about Taiho's Zipalertinib Expanded Access Program via email ([email protected]). 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Past medical history of interstitial lung disease, treatment-related pneumonitis (any grade), or evidence of clinically active interstitial lung disease
History of congestive heart failure Class III/IV according to the New York Heart Association Functional Classification
Serious cardiac arrhythmias requiring treatment
Use of zipalertinib (TAS6417/CLN-081) at any time.
Trial design
Treatments tested in this trial
- Zipalertinib
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov