Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT05430802
Eligibility Criteria:
Inclusion Criteria:
* With written informed consent before any study procedure
* Histology or cytology diagnose of non-small cell lung cancer within 60 days
* Stage IIIA/IIIB, with resectable lesion(s) by radiology
* EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
* Without prior anti-tumor treatment
* With at least one measurable lesions (The longest axis ≥10mm)
* ECOG performance status 0-1
* Using adequate and effective contraception, women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age
Exclusion Criteria:
* EGFR Exon 20 insertions positive
* Mixed with small cell cancer, or other mixed types of lung cancer
* Any prior anti-tumor treatment
* Major surgery within 4 weeks before enrolment
* Women with pregnancy or breastfeeding
* Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrolment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrolment
* With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
* With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
* Severe gastrointestinal diseases which may affect the intake and absorption of study drug
* Prolongation of ECG QTc or with relative risk factors
* History of interstitial lung disease or with relative risk factors
* Inadequate organ function of hematology, liver and kidney
* Allergic to study drugs or any component
* Poor adherence or other situation judged by investigator
* Patients who had participated other clinical studies of tumors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05430802
Study Brief:
Protocol Section:
NCT05430802