NIPH Clinical Trials Search

TAS6417 FE study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	EGFR-mutant NSCLC
Date of first enrollment	05/06/2026
Target sample size	16
Countries of recruitment
Study type	Interventional
Intervention(s)	- 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 dosing. Except at the time of study drug administration, water intake will be prohibited from 1 hour before until 1 hour after dosing. Following a washout period after the first single-dose administration and after fasting for 10 hours or more, patients will begin consumption of a high-fat test meal starting 30 minutes prior to the scheduled dosing time of zipalertinib, which must be completely consumed within 30 minutes. At the scheduled dosing time, zipalertinib will be administered orally at a dose of 100 mg, patients will continue fasting until 4 hours after dosing. Except at the time of study drug administration, water intake will be prohibited from 1 hour before until 1 hour after dosing. - Group B (Fed-first administration group) After fasting for 10 hours or more, patients will begin consumption of a high-fat test meal starting 30 minutes prior to the scheduled dosing time of zipalertinib, which must be completely consumed within 30 minutes. At the scheduled dosing time, zipalertinib will be administered orally at a dose of 100 mg, and patients will continue fasting until 4 hours after dosing. Except at the time of study drug administration, water intake will be prohibited from 1 hour before until 1 hour after dosing. Following a washout period after the first single-dose administration and 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 dosing. Except at the time of study drug administration, water intake will be prohibited from 1 hour before until 1 hour after dosing.

Outcome(s)

Primary Outcome	PK parameters of zipalertinib (Cmax, AUClast, AUCinf)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.