EGFR-mutant NSCLC
Conditions
Interventions
- Group A (Fasting-first administration group)
After fasting for 10 hours or more, Zipalertinib will be administered orally at a dose of 100 mg, and patients will continue fasting until 4 hours after
Sponsors
Hida Toyoaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provided written informed consent. 2. Is >= 18 years of age at the time of informed consent. 3. Histologically or cytologically confirmed locally advanced or metastatic nonsqauamous NSCLC, characterized at or after the time of locally advanced or metastatic disease diagnosis by EGFR mutation. 4. Refractory to prior therapies, unable to receive generally accepted standard therapies, or unwilling to receive such therapies.
Exclusion criteria
Exclusion criteria: 1. Documented EGFR C797S mutation-positive status Histologically or cytologically confirmed locally advanced or metastatic nonsqauamous NSCLC 2. Have any unresolved toxicity of Grade >= 2 from previous anticancer treatment except for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the investigator and Sponsor. 3. Have allergy to any components of the high-fat test meal. 4. Use tobacco products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters of zipalertinib (Cmax, AUClast, AUCinf) | — |
Contacts
Public ContactKana Matsubara
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed