{
    "info": {
        "nct_id": "NCT01004731",
        "official_title": "Phase Ib, IIa Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* Have a diagnosis of histologically/cytologically confirmed advanced non- small cell lung cancer (NSCLC).\n* Have uni-dimensionally measurable and/or evaluable advanced NSCLC.\n* Have Stage IV or recurrent disease following radiation therapy.\n* Have ECOG performance status of 0-1 or Karnofsky performance status of 80- 100 at study entry.\n* Have given signed informed consent.\n* Be at least 18 years of age.\n* Have ANC greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, WBC greater than or equal to 3,000 mm3, and hemoglobin greater than or equal to 9 g/dL.\n* Have total bilirubin less than or equal to 1.5 x upper limits of normal, Alk Phos, AST and ALT less than or equal to 2.5 x upper limits of normal.\n* Have serum creatinine less than or equal to 1.5 mg/dL, or calculated creatinine clearance greater than or equal to 60 cc/minute.\n* Be disease free from a previously treated malignancy for more than three years. Patients with a history or a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix will not be excluded.\n* Agree to use effective contraception if procreative potential exists.\n* Must have positive EGFr expression (tumor tissue) by immunohistochemical assay.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Have received prior murine monoclonal antibody or Cetuximab therapy.\n* Have disease amenable to curative surgery.\n* Have received prior chemotherapy.\n* Have received radiation therapy within 3 weeks prior to the first infusion of Cetuximab.\n* Have a history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities, in the judgment of the PI.\n* Have uncontrolled seizure disorder, active neurological disease, or Grade 2 or higher neuropathy.\n* Be pregnant or breast-feeding.\n* Have received any investigational agent(s) within 1 month of study entry.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Have a diagnosis of histologically/cytologically confirmed advanced non- small cell lung cancer (NSCLC).",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of histologically/cytologically confirmed advanced non- small cell lung cancer (NSCLC)",
                    "criterion": "non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have uni-dimensionally measurable and/or evaluable advanced NSCLC.",
            "criterions": [
                {
                    "exact_snippets": "uni-dimensionally measurable",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": "uni-dimensionally measurable"
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluable advanced NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        },
                        {
                            "requirement_type": "evaluable",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have Stage IV or recurrent disease following radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "Stage IV",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent disease",
                    "criterion": "disease recurrence",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "following radiation therapy",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": "radiation therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have ECOG performance status of 0-1 or Karnofsky performance status of 80- 100 at study entry.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky performance status of 80- 100",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 80,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have given signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": "given signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "at least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have ANC greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, WBC greater than or equal to 3,000 mm3, and hemoglobin greater than or equal to 9 g/dL.",
            "criterions": [
                {
                    "exact_snippets": "ANC greater than or equal to 1,500/mm3",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets greater than or equal to 100,000/mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "WBC greater than or equal to 3,000 mm3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin greater than or equal to 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have total bilirubin less than or equal to 1.5 x upper limits of normal, Alk Phos, AST and ALT less than or equal to 2.5 x upper limits of normal.",
            "criterions": [
                {
                    "exact_snippets": "total bilirubin less than or equal to 1.5 x upper limits of normal",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper limits of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alk Phos ... less than or equal to 2.5 x upper limits of normal",
                    "criterion": "Alk Phos",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x upper limits of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ... less than or equal to 2.5 x upper limits of normal",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x upper limits of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT less than or equal to 2.5 x upper limits of normal",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x upper limits of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have serum creatinine less than or equal to 1.5 mg/dL, or calculated creatinine clearance greater than or equal to 60 cc/minute.",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine less than or equal to 1.5 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine clearance greater than or equal to 60 cc/minute",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "cc/minute"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be disease free from a previously treated malignancy for more than three years. Patients with a history or a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix will not be excluded.",
            "criterions": [
                {
                    "exact_snippets": "disease free from a previously treated malignancy for more than three years",
                    "criterion": "previously treated malignancy",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history or a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix will not be excluded",
                    "criterion": "history of basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agree to use effective contraception if procreative potential exists.",
            "criterions": [
                {
                    "exact_snippets": "Agree to use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "procreative potential exists",
                    "criterion": "procreative potential",
                    "requirements": [
                        {
                            "requirement_type": "existence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have positive EGFr expression (tumor tissue) by immunohistochemical assay.",
            "criterions": [
                {
                    "exact_snippets": "positive EGFr expression (tumor tissue) by immunohistochemical assay",
                    "criterion": "EGFr expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": "immunohistochemical assay"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Have received prior murine monoclonal antibody or Cetuximab therapy.",
            "criterions": [
                {
                    "exact_snippets": "Have received prior murine monoclonal antibody",
                    "criterion": "prior murine monoclonal antibody therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Have received prior ... Cetuximab therapy",
                    "criterion": "prior Cetuximab therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have disease amenable to curative surgery.",
            "criterions": [
                {
                    "exact_snippets": "disease amenable to curative surgery",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "amenability to curative surgery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received prior chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Have received prior chemotherapy.",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received radiation therapy within 3 weeks prior to the first infusion of Cetuximab.",
            "criterions": [
                {
                    "exact_snippets": "received radiation therapy within 3 weeks prior to the first infusion of Cetuximab",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities, in the judgment of the PI.",
            "criterions": [
                {
                    "exact_snippets": "clinically significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant conduction abnormalities",
                    "criterion": "conduction abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have uncontrolled seizure disorder, active neurological disease, or Grade 2 or higher neuropathy.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled seizure disorder",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "active neurological disease",
                    "criterion": "neurological disease",
                    "requirements": [
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Grade 2 or higher neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be pregnant or breast-feeding.",
            "criterions": [
                {
                    "exact_snippets": "Be pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received any investigational agent(s) within 1 month of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Have received any investigational agent(s) within 1 month of study entry.",
                    "criterion": "investigational agent(s)",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}