[96a5a0]: / output / allTrials / logical / NCT00965731_logical.json

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{
"info": {
"nct_id": "NCT00965731",
"official_title": "Phase 1/2, Open Label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Erlotinib With Or Without Pf 02341066 In Patients With Advanced Non Small Cell Adenocarcinoma Of The Lung.",
"inclusion_criteria": "* histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)\n* evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease\n* tumors must have measurable disease as per RECIST\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* known interstitial lung disease\n* prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease",
"criterions": [
{
"exact_snippets": "evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST)",
"criterion": "disease progression",
"requirement": {
"requirement_type": "evaluation method",
"expected_value": "Response Evaluation Criterion in Solid Tumors (RECIST)"
}
},
{
"exact_snippets": "after at least one but no more than 2 chemotherapy regimens for advanced disease",
"criterion": "chemotherapy regimens for advanced disease",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "regimens"
},
{
"operator": "<=",
"value": 2,
"unit": "regimens"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST)",
"criterion": "disease progression",
"requirement": {
"requirement_type": "evaluation method",
"expected_value": "Response Evaluation Criterion in Solid Tumors (RECIST)"
}
},
{
"exact_snippets": "after at least one but no more than 2 chemotherapy regimens for advanced disease",
"criterion": "chemotherapy regimens for advanced disease",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "regimens"
},
{
"operator": "<=",
"value": 2,
"unit": "regimens"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* tumors must have measurable disease as per RECIST",
"criterions": [
{
"exact_snippets": "tumors must have measurable disease as per RECIST",
"criterion": "tumors",
"requirement": {
"requirement_type": "measurable disease",
"expected_value": "as per RECIST"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "tumors must have measurable disease as per RECIST",
"criterion": "tumors",
"requirement": {
"requirement_type": "measurable disease",
"expected_value": "as per RECIST"
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* known interstitial lung disease",
"criterions": [
{
"exact_snippets": "known interstitial lung disease",
"criterion": "interstitial lung disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "known interstitial lung disease",
"criterion": "interstitial lung disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)",
"criterions": [
{
"exact_snippets": "prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase",
"criterion": "prior treatment with EGFR tyrosine kinase agent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "prior treatment with an agent that is known or proposed to be active by action on ... c-Met/HGF",
"criterion": "prior treatment with c-Met/HGF agent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase",
"criterion": "prior treatment with EGFR tyrosine kinase agent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "prior treatment with an agent that is known or proposed to be active by action on ... c-Met/HGF",
"criterion": "prior treatment with c-Met/HGF agent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)",
"criterions": [
{
"exact_snippets": "histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC)",
"criterion": "Non-Small Cell Lung Cancer (NSCLC)",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "locally advanced or metastatic",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"metastatic"
]
}
},
{
"exact_snippets": "adenocarcinoma subtype (including mixed adenosquamous histology)",
"criterion": "adenocarcinoma subtype",
"requirement": {
"requirement_type": "subtype",
"expected_value": [
"adenocarcinoma",
"mixed adenosquamous histology"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC)",
"criterion": "Non-Small Cell Lung Cancer (NSCLC)",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "locally advanced or metastatic",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
},
{
"exact_snippets": "locally advanced or metastatic",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "metastatic"
}
}
]
}
]
},
{
"or_criteria": [
{
"exact_snippets": "adenocarcinoma subtype (including mixed adenosquamous histology)",
"criterion": "adenocarcinoma subtype",
"requirement": {
"requirement_type": "subtype",
"expected_value": "adenocarcinoma"
}
},
{
"exact_snippets": "adenocarcinoma subtype (including mixed adenosquamous histology)",
"criterion": "adenocarcinoma subtype",
"requirement": {
"requirement_type": "subtype",
"expected_value": "mixed adenosquamous histology"
}
}
]
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}