{
"info": {
"nct_id": "NCT01665417",
"official_title": "Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma",
"inclusion_criteria": "* Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "* Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).",
"criterions": [
{
"exact_snippets": [
"Pathologic confirmation of lung adenocarcinoma"
],
"criterion": "lung adenocarcinoma",
"requirement_type": "confirmation",
"expected_value": true
},
{
"exact_snippets": [
"measurable disease",
"at least one lesion that can be accurately measured"
],
"criterion": "disease",
"requirement_type": "measurability",
"expected_value": true
},
{
"exact_snippets": [
"previously untreated locally advanced or metastatic NSCLC"
],
"criterion": "NSCLC",
"requirement_type": "treatment status",
"expected_value": "untreated"
},
{
"exact_snippets": [
"lung cancer with a documented EGFR activating mutation",
"exon 19 deletion, L858R"
],
"criterion": "EGFR activating mutation",
"requirement_type": "documentation",
"expected_value": [
"exon 19 deletion",
"L858R"
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
},
{
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": [
"maximum age of 70 Years"
],
"criterion": "age",
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70
}
}
]
}
],
"exclusion_lines": [
{
"line": "* Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease",
"criterions": [
{
"exact_snippets": [
"Prior chemotherapy"
],
"criterion": "chemotherapy",
"requirement_type": "prior treatment",
"expected_value": true
},
{
"exact_snippets": [
"Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR"
],
"criterion": "EGFR-targeting drugs",
"requirement_type": "prior treatment",
"expected_value": true
},
{
"exact_snippets": [
"Patients must not be receiving any other investigational agents"
],
"criterion": "investigational agents",
"requirement_type": "current treatment",
"expected_value": false
},
{
"exact_snippets": [
"Any evidence of interstitial lung disease"
],
"criterion": "interstitial lung disease",
"requirement_type": "presence",
"expected_value": true
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}