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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT02625168
Eligibility Criteria:
Inclusion Criteria:
* Patients with stage IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who were previously responsive to one line of EGFR tyrosine kinase inhibitor and at least one line of systemic chemotherapy
* Adequate hematological function (ANC \>=1.5 x 10\^9/l, Hb \>=9.0 x 10\^9/l, plt \>=100 x 10\^9/l)
* Adequate renal function (with estimated creatinine clearance \>=50ml/min as determined by Cockcroft-Gault formula)
* Adequate liver function (ALT/AST \<2.5 x upper normal limit or ALT/AST \<5 x upper normal limit in the presence of liver metastasis)
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Evaluable target lesions according to RECIST 1.1 for tumour response assessment
* Patients able to give written consent
Exclusion Criteria:
* Symptomatic brain metastases requiring steroids/surgery/radiation therapy within 4 weeks of commencement of study medication
* Significant cardiovascular abnormalities
* Significant psychiatric disorders
* Patients who have documented history of interstitial lung disease
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02625168
Study Brief:
Protocol Section:
NCT02625168