{
"info": {
"nct_id": "NCT00520676",
"official_title": "A Randomized Phase 3 Study Comparing Pemetrexed-Carboplatin With Docetaxel-Carboplatin as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer",
"inclusion_criteria": "* Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment\n* Easter Cooperative Oncology Group (ECOG) performance status 0 to 2\n* Estimated life expectancy of at least 8 weeks\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Known or suspected brain metastases\n* Concurrent administration of any other tumor therapy\n* Serious concomitant disorders\n* Pregnancy or breast feeding\n* Inability or unwillingness to take folic acid or vitamin B12 supplementation",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment",
"criterions": [
{
"exact_snippets": "locally advanced or metastatic (Stage IIIB/IV) NCSLC",
"criterion": "NCSLC stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"Stage IIIB",
"Stage IV"
]
}
]
},
{
"exact_snippets": "no prior chemotherapy for advanced disease",
"criterion": "prior chemotherapy for advanced disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "no prior ... molecular target treatment",
"criterion": "prior molecular target treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Easter Cooperative Oncology Group (ECOG) performance status 0 to 2",
"criterions": [
{
"exact_snippets": "Easter Cooperative Oncology Group (ECOG) performance status 0 to 2",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Estimated life expectancy of at least 8 weeks",
"criterions": [
{
"exact_snippets": "Estimated life expectancy of at least 8 weeks",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "weeks"
}
}
]
}
]
},
{
"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": "* Known or suspected brain metastases",
"criterions": [
{
"exact_snippets": "Known or suspected brain metastases",
"criterion": "brain metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Concurrent administration of any other tumor therapy",
"criterions": [
{
"exact_snippets": "Concurrent administration of any other tumor therapy",
"criterion": "concurrent tumor therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Serious concomitant disorders",
"criterions": [
{
"exact_snippets": "Serious concomitant disorders",
"criterion": "concomitant disorders",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "serious"
}
]
}
]
},
{
"line": "* Pregnancy or breast feeding",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "breast feeding",
"criterion": "breast feeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Inability or unwillingness to take folic acid or vitamin B12 supplementation",
"criterions": [
{
"exact_snippets": "Inability or unwillingness to take folic acid",
"criterion": "folic acid supplementation",
"requirements": [
{
"requirement_type": "ability or willingness",
"expected_value": true
}
]
},
{
"exact_snippets": "Inability or unwillingness to take ... vitamin B12 supplementation",
"criterion": "vitamin B12 supplementation",
"requirements": [
{
"requirement_type": "ability or willingness",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}