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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT01573702
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* 18 years of age or older
* Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC
* History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria
* Progressive disease following EGFR-TKI therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate organ and marrow function
* Negative urine or serum pregnancy test for female patients
* Patients who can have children must agree to adequate contraception
Exclusion Criteria:
* Unresolved chronic toxicities greater than 2, measured by CTCAE v4
* Treatment with any FDA approved or experimental cancer treatment following progression on EGFR-TKI
* Any history of previous greater than grade 3 toxicity attributable to erlotinib
* Pregnant or lactating female
* Any previous radiation to sites of planned Stereostatic Radiosurgery
* History of another malignancy
* Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks)
* Evidence of severe or uncontrolled systemic diseases
* Known hypersensitivity reaction or idiosyncrasy to erlotinib
* Psychological, familial, sociological, or geographical conditions
* Any other condition in investigator's opinion jeopardize compliance with protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01573702
Study Brief:
Protocol Section:
NCT01573702