{
"info": {
"nct_id": "NCT00254891",
"official_title": "International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer",
"inclusion_criteria": "* Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV\n* No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs\n* Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Small cell or carcinoid lung cancer\n* Known Central Nervous System (CNS) metastasis\n* Pre-existing auto-immune or antibody mediated diseases",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV",
"criterions": [
{
"exact_snippets": "Advanced Non-Small-Cell Lung Cancer (NSCLC)",
"criterion": "Non-Small-Cell Lung Cancer (NSCLC)",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "advanced"
}
]
},
{
"exact_snippets": "stage IIIB with pleural effusion",
"criterion": "NSCLC stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "IIIB"
},
{
"requirement_type": "condition",
"expected_value": "pleural effusion"
}
]
},
{
"exact_snippets": "stage IV",
"criterion": "NSCLC stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "IV"
}
]
}
]
},
{
"line": "* Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1",
"criterion": "Eastern Cooperative Oncology Performance Status (ECOG PS)",
"requirements": [
{
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Small cell or carcinoid lung cancer",
"criterions": [
{
"exact_snippets": "Small cell ... lung cancer",
"criterion": "small cell lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "carcinoid lung cancer",
"criterion": "carcinoid lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Known Central Nervous System (CNS) metastasis",
"criterions": [
{
"exact_snippets": "Known Central Nervous System (CNS) metastasis",
"criterion": "Central Nervous System (CNS) metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Pre-existing auto-immune or antibody mediated diseases",
"criterions": [
{
"exact_snippets": "Pre-existing auto-immune or antibody mediated diseases",
"criterion": "auto-immune diseases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Pre-existing auto-immune or antibody mediated diseases",
"criterion": "antibody mediated diseases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "* No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs",
"criterions": [
{
"exact_snippets": "No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with chemotherapy",
"criterion": "prior systemic treatment with chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with ... immunotherapy",
"criterion": "prior systemic treatment with immunotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with ... biologic response modifiers",
"criterion": "prior systemic treatment with biologic response modifiers",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with ... other investigational drugs",
"criterion": "prior systemic treatment with other investigational drugs",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}