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:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT03513666
Eligibility Criteria:
Inclusion Criteria:
Only the patients meeting all the following criteria can be eligible to participate in the trial:
* Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time:
* Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease;
* No exon 20 T790M mutation after failure of EGFR-TKI therapy;
* At least one measurable lesion (in accordance with RECIST 1.1);
Exclusion Criteria:
Patients who fulfill any of the following criteria must be excluded from the study:
* Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component \>10%;
* Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.;
* Previous systemic chemotherapy for advanced NSCLC;
* EGFR-TKI therapy within two weeks prior to enrollment;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03513666
Study Brief:
Protocol Section:
NCT03513666