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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT04116918
Eligibility Criteria:
Inclusion Criteria:
* Adult patients \>=18 years of age
* Inoperable locally advanced, recurrent, and/or metastatic NSCLC patients with EGFR sensitive mutation
* EGFR-TKI resistent
* EGFR T790M negative
* Expected survival ≥ 3 month;
* ECOG / PS score: 0-2;
* the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
Exclusion Criteria:
* EGFR-T790M positive
* with druggable gene alteration;
* Patient can not comply with research program requirements or follow-up;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
75 Years
Study:
NCT04116918
Study Brief:
Protocol Section:
NCT04116918