{
    "info": {
        "nct_id": "NCT02276560",
        "official_title": "Phase II Multicenter Trial of Neoadjuvant Cisplatin and Nab-paclitaxel for (N2) Defined Stage IIIA Non-Small Cell Lung Cancer (NSCLC)",
        "inclusion_criteria": "* 18 years of age; no upper age limit\n* Diagnosis of NSCLC, histologically or cytologically confirmed\n* Pathologic mediastinal staging to include endobronchial ultrasound with or without endoscopic ultrasound (EBUS =/- EUS) including evaluation of N3 nodes\n* Systemic staging including CT that covers the chest, liver and adrenal glands or a PET/CT; MRI of the brain is required and must be negative for metastatic spread. If a patient is unable to tolerate MRI or has a contraindication to MRI, a head CT scan with and without contrast is acceptable\n* International Association for the Study of Lung Cancer (IASLC) version 7, subset of stage IIIA single station (N2) disease; specifically T1a-T3, N2(+) with no invasion of key structures (e.g., chest wall or diaphragm)\n* Surgically resectable disease, and patient deemed an appropriate surgical candidate by a thoracic surgeon prior to enrollment\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Adequate organ and bone marrow function as defined by:\n\nAbsolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Hemoglobin ≥ 10g/dL (it is acceptable to reach this through transfusion); Platelets > 100,000 cells/mm3; Creatinine clearance ≥ 60 mg/dL (Cockcroft-Gault equation); Total bilirubin ≤ 1.5 mg/dL; Alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN; Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN;\n\n* Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry, for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care\n* Negative serum or urine Human Chorionic Gonadotropin(b-hCG) pregnancy test within 14 days of D1 of neoadjuvant chemotherapy for women of childbearing potential\n* Informed consent obtained and signed\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Forced expiratory volume (FEV) ≤ 1.2 L/s\n* T3 tumor defined by invasion of key structures (only T3 defined by size > 7cm allowed)\n* Any lymph code > 3 cm or multistation N2 lymphadenopathy\n* Patient better served by concurrent chemoradiotherapy: The protocol recognizes that institutional standards regarding which patients are best served by operative and nonoperative approaches vary. Therefore, consistent with the American College of Chest Physicians (ACCP) guidelines, the protocol recommends multidisciplinary discussion of each patient and enrollment only of patients felt best serviced by the approach described herein\n* ≥ Grade 2 pre-existing peripheral neuropathy (per CTCAEv4)\n* Prior history of hypersensitivity to taxane or platinum therapy. If either agent was previously administered, the patient must have tolerated it well and have recovered from any adverse events\n* Recurrent disease or second primary lung cancer (only de novo IIIA disease allowed)\n* Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion.\n* Prior treatment of any kind for this malignancy\n* Have received treatment with any drug that has not received regulatory approval for that indication within the 30 days prior to study entry\n* Any serious, uncontrolled medical disorder that would impair the ability of the subject to receive protocol driven therapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 18 years of age; no upper age limit",
            "criterions": [
                {
                    "exact_snippets": "18 years of age; no upper age limit",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of NSCLC, histologically or cytologically confirmed",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of NSCLC",
                    "criterion": "NSCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathologic mediastinal staging to include endobronchial ultrasound with or without endoscopic ultrasound (EBUS =/- EUS) including evaluation of N3 nodes",
            "criterions": [
                {
                    "exact_snippets": "Pathologic mediastinal staging",
                    "criterion": "mediastinal staging",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "endobronchial ultrasound",
                                "endoscopic ultrasound"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluation of N3 nodes",
                    "criterion": "N3 nodes",
                    "requirements": [
                        {
                            "requirement_type": "evaluation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systemic staging including CT that covers the chest, liver and adrenal glands or a PET/CT; MRI of the brain is required and must be negative for metastatic spread. If a patient is unable to tolerate MRI or has a contraindication to MRI, a head CT scan with and without contrast is acceptable",
            "criterions": [
                {
                    "exact_snippets": "Systemic staging including CT that covers the chest, liver and adrenal glands or a PET/CT",
                    "criterion": "systemic staging",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MRI of the brain is required",
                    "criterion": "brain MRI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MRI of the brain ... must be negative for metastatic spread",
                    "criterion": "brain MRI",
                    "requirements": [
                        {
                            "requirement_type": "metastatic spread",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "If a patient is unable to tolerate MRI or has a contraindication to MRI, a head CT scan with and without contrast is acceptable",
                    "criterion": "head CT scan",
                    "requirements": [
                        {
                            "requirement_type": "alternative to MRI",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* International Association for the Study of Lung Cancer (IASLC) version 7, subset of stage IIIA single station (N2) disease; specifically T1a-T3, N2(+) with no invasion of key structures (e.g., chest wall or diaphragm)",
            "criterions": [
                {
                    "exact_snippets": "International Association for the Study of Lung Cancer (IASLC) version 7",
                    "criterion": "IASLC version",
                    "requirements": [
                        {
                            "requirement_type": "version",
                            "expected_value": "7"
                        }
                    ]
                },
                {
                    "exact_snippets": "subset of stage IIIA single station (N2) disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IIIA"
                        },
                        {
                            "requirement_type": "station",
                            "expected_value": "single station (N2)"
                        }
                    ]
                },
                {
                    "exact_snippets": "T1a-T3",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N2(+)",
                    "criterion": "nodal involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "N2(+)"
                        }
                    ]
                },
                {
                    "exact_snippets": "no invasion of key structures (e.g., chest wall or diaphragm)",
                    "criterion": "invasion of key structures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgically resectable disease, and patient deemed an appropriate surgical candidate by a thoracic surgeon prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "Surgically resectable disease",
                    "criterion": "disease resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patient deemed an appropriate surgical candidate by a thoracic surgeon",
                    "criterion": "surgical candidacy",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": "thoracic surgeon"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 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"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ and bone marrow function as defined by:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ and bone marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ and bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Hemoglobin ≥ 10g/dL (it is acceptable to reach this through transfusion); Platelets > 100,000 cells/mm3; Creatinine clearance ≥ 60 mg/dL (Cockcroft-Gault equation); Total bilirubin ≤ 1.5 mg/dL; Alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN; Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN;",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ≥ 10g/dL (it is acceptable to reach this through transfusion)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets > 100,000 cells/mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine clearance ≥ 60 mg/dL (Cockcroft-Gault equation)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 mg/dL",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN)",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN",
                    "criterion": "alanine aminotransferase (ALT, SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN",
                    "criterion": "aspartate aminotransferase (AST, SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry, for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sexually active men",
                    "criterion": "sexually active men",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use effective contraception",
                    "criterion": "agreement to use effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to study entry, for the duration of study participation and for three months after completing treatment",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "time period",
                            "expected_value": "prior to study entry, for the duration of study participation and for three months after completing treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care",
                    "criterion": "adequate contraception",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "any medically recommended method (or combination of methods) per standard of care"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative serum or urine Human Chorionic Gonadotropin(b-hCG) pregnancy test within 14 days of D1 of neoadjuvant chemotherapy for women of childbearing potential",
            "criterions": [
                {
                    "exact_snippets": "Negative serum or urine Human Chorionic Gonadotropin(b-hCG) pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days of D1 of neoadjuvant chemotherapy",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent obtained and signed",
            "criterions": [
                {
                    "exact_snippets": "Informed consent obtained and signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "obtained and signed"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Forced expiratory volume (FEV) ≤ 1.2 L/s",
            "criterions": [
                {
                    "exact_snippets": "Forced expiratory volume (FEV) ≤ 1.2 L/s",
                    "criterion": "forced expiratory volume (FEV)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.2,
                                "unit": "L/s"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T3 tumor defined by invasion of key structures (only T3 defined by size > 7cm allowed)",
            "criterions": [
                {
                    "exact_snippets": "T3 tumor defined by invasion of key structures",
                    "criterion": "T3 tumor",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "invasion of key structures"
                        }
                    ]
                },
                {
                    "exact_snippets": "T3 defined by size > 7cm",
                    "criterion": "T3 tumor",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 7,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any lymph code > 3 cm or multistation N2 lymphadenopathy",
            "criterions": [
                {
                    "exact_snippets": "Any lymph code > 3 cm",
                    "criterion": "lymph node size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "multistation N2 lymphadenopathy",
                    "criterion": "N2 lymphadenopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "multistation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient better served by concurrent chemoradiotherapy: The protocol recognizes that institutional standards regarding which patients are best served by operative and nonoperative approaches vary. Therefore, consistent with the American College of Chest Physicians (ACCP) guidelines, the protocol recommends multidisciplinary discussion of each patient and enrollment only of patients felt best serviced by the approach described herein",
            "criterions": [
                {
                    "exact_snippets": "Patient better served by concurrent chemoradiotherapy",
                    "criterion": "treatment suitability",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "concurrent chemoradiotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ Grade 2 pre-existing peripheral neuropathy (per CTCAEv4)",
            "criterions": [
                {
                    "exact_snippets": "≥ Grade 2 pre-existing peripheral neuropathy (per CTCAEv4)",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior history of hypersensitivity to taxane or platinum therapy. If either agent was previously administered, the patient must have tolerated it well and have recovered from any adverse events",
            "criterions": [
                {
                    "exact_snippets": "Prior history of hypersensitivity to taxane",
                    "criterion": "hypersensitivity to taxane",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior history of hypersensitivity to ... platinum therapy",
                    "criterion": "hypersensitivity to platinum therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "If either agent was previously administered, the patient must have tolerated it well",
                    "criterion": "tolerance to taxane or platinum therapy",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "If either agent was previously administered, the patient must have ... recovered from any adverse events",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrent disease or second primary lung cancer (only de novo IIIA disease allowed)",
            "criterions": [
                {
                    "exact_snippets": "Recurrent disease",
                    "criterion": "recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "second primary lung cancer",
                    "criterion": "second primary lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "only de novo IIIA disease allowed",
                    "criterion": "de novo IIIA disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion.",
            "criterions": [
                {
                    "exact_snippets": "Other active, invasive malignancy requiring ongoing therapy",
                    "criterion": "active, invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "therapy requirement",
                            "expected_value": "ongoing therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "active, invasive malignancy ... expected to require systemic therapy within two years",
                    "criterion": "active, invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "therapy requirement",
                            "expected_value": "systemic therapy within two years"
                        }
                    ]
                },
                {
                    "exact_snippets": "localized squamous cell carcinoma of the skin",
                    "criterion": "localized squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "basal-cell carcinoma of the skin",
                    "criterion": "basal-cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in-situ of the cervix",
                    "criterion": "carcinoma in-situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other malignancies requiring locally ablative therapy only",
                    "criterion": "other malignancies requiring locally ablative therapy only",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment of any kind for this malignancy",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment of any kind for this malignancy",
                    "criterion": "prior treatment for malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received treatment with any drug that has not received regulatory approval for that indication within the 30 days prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Have received treatment with any drug that has not received regulatory approval for that indication",
                    "criterion": "treatment with unapproved drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any serious, uncontrolled medical disorder that would impair the ability of the subject to receive protocol driven therapy",
            "criterions": [
                {
                    "exact_snippets": "serious, uncontrolled medical disorder",
                    "criterion": "medical disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}