{
    "info": {
        "nct_id": "NCT00098462",
        "official_title": "A Phase I/II Trial of ZD1839 (Iressa®) and Rapamycin (Rapamune) in Patients With Advanced Non Small Cell Lung Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed non-small cell lung cancer\n\n  * Stage IIIB or IV disease\n* Recurrent or refractory disease\n\n  * Received ≥ 1 prior platinum-containing chemotherapy regimen\n* Unidimensionally measurable disease that has not been irradiated\n* No newly diagnosed untreated brain metastases or spinal cord compression\n* Paraffin-embedded tumor tissue or slides available\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Adequate bone marrow function\n* Absolute neutrophil count ≥ 1,500/mm^3\n* Platelet count ≥ 100,000/mm^3\n\nHepatic\n\n* Adequate hepatic function\n* No severe or uncontrolled hepatic disease\n\nRenal\n\n* Adequate renal function\n* Creatinine ≤ 3.0 times upper limit of normal\n* No severe or uncontrolled renal disease\n\nCardiovascular\n\n* Adequate cardiac function\n* No severe or uncontrolled cardiac disease\n* No uncontrolled hyperlipidemia\n\nPulmonary\n\n* No unstable or uncompensated respiratory disease\n* No clinically active interstitial lung disease\n\n  * Patients with chronic stable radiographic changes who are asymptomatic are eligible\n\nGastrointestinal\n\n* Able to take oral medication\n* No gastrointestinal condition (e.g., peptic ulcer disease) that would affect absorption\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No serious infection\n* No known severe hypersensitivity to gefitinib or any of its excipients\n* No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No other severe or uncontrolled systemic disease\n* No significant clinical disorder or laboratory finding that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 14 days since prior biologic therapy\n* No prior cetuximab, panitumumab, or bevacizumab\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior cytotoxic chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* More than 3 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* Recovered from prior oncologic or other major surgery\n* No prior gastrointestinal surgery affecting absorption\n* No concurrent surgery, including ophthalmic surgery, during and for 1 week after study treatment\n\nOther\n\n* Recovered from all prior therapy\n* More than 30 days since prior investigational agents\n* No other prior HER1/epidermal growth factor receptor axis agents, including the following:\n\n  * Gefitinib\n  * Erlotinib\n  * CI-1033\n  * Lapatinib\n* No other prior vascular endothelial growth factor axis agents, including the following:\n\n  * ZD6474\n  * Vatalanib\n* No concurrent CYP3A4 inducers, including the following:\n\n  * Phenytoin\n  * Carbamazepine\n  * Rifampin\n  * Phenobarbital\n  * Barbiturates\n  * Hypericum perforatum (St. John's wort)\n* No other concurrent systemic treatment for the malignancy\n* No concurrent bisphosphonates for symptomatic bone metastases\n* No concurrent systemic retinoids"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed non-small cell lung cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IIIB or IV disease",
            "criterions": [
                {
                    "exact_snippets": "Stage IIIB or IV disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB",
                                "IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrent or refractory disease",
            "criterions": [
                {
                    "exact_snippets": "Recurrent",
                    "criterion": "disease recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory disease",
                    "criterion": "disease refractoriness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received ≥ 1 prior platinum-containing chemotherapy regimen",
            "criterions": [
                {
                    "exact_snippets": "Received ≥ 1 prior platinum-containing chemotherapy regimen",
                    "criterion": "prior platinum-containing chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unidimensionally measurable disease that has not been irradiated",
            "criterions": [
                {
                    "exact_snippets": "Unidimensionally measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurement type",
                            "expected_value": "unidimensional"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease that has not been irradiated",
                    "criterion": "disease irradiation status",
                    "requirements": [
                        {
                            "requirement_type": "irradiation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No newly diagnosed untreated brain metastases or spinal cord compression",
            "criterions": [
                {
                    "exact_snippets": "No newly diagnosed untreated brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis status",
                            "expected_value": "not newly diagnosed"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "No newly diagnosed untreated ... spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis status",
                            "expected_value": "not newly diagnosed"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Paraffin-embedded tumor tissue or slides available",
            "criterions": [
                {
                    "exact_snippets": "Paraffin-embedded tumor tissue or slides available",
                    "criterion": "paraffin-embedded tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Paraffin-embedded tumor tissue or slides available",
                    "criterion": "slides",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age",
            "criterions": [
                {
                    "exact_snippets": "Age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 and over",
            "criterions": [
                {
                    "exact_snippets": "18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status",
            "criterions": [
                {
                    "exact_snippets": "Performance status",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Life expectancy",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic",
                    "criterion": "hematopoietic",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow function",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500/mm^3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hepatic function",
            "criterions": [
                {
                    "exact_snippets": "Adequate hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe or uncontrolled hepatic disease",
            "criterions": [
                {
                    "exact_snippets": "No severe or uncontrolled hepatic disease",
                    "criterion": "hepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal",
            "criterions": [
                {
                    "exact_snippets": "Renal",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 3.0 times upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 3.0 times upper limit of normal",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe or uncontrolled renal disease",
            "criterions": [
                {
                    "exact_snippets": "severe or uncontrolled renal disease",
                    "criterion": "renal disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate cardiac function",
            "criterions": [
                {
                    "exact_snippets": "Adequate cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe or uncontrolled cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "severe or uncontrolled cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled hyperlipidemia",
            "criterions": [
                {
                    "exact_snippets": "No uncontrolled hyperlipidemia",
                    "criterion": "hyperlipidemia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pulmonary",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary",
                    "criterion": "pulmonary",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unstable or uncompensated respiratory disease",
            "criterions": [
                {
                    "exact_snippets": "No unstable or uncompensated respiratory disease",
                    "criterion": "respiratory disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        },
                        {
                            "requirement_type": "compensation",
                            "expected_value": "compensated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinically active interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "clinically active interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with chronic stable radiographic changes who are asymptomatic are eligible",
            "criterions": [
                {
                    "exact_snippets": "chronic stable radiographic changes",
                    "criterion": "radiographic changes",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "chronic stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic",
                    "criterion": "symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Gastrointestinal",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal",
                    "criterion": "gastrointestinal condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to take oral medication",
            "criterions": [
                {
                    "exact_snippets": "Able to take oral medication",
                    "criterion": "ability to take oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No gastrointestinal condition (e.g., peptic ulcer disease) that would affect absorption",
            "criterions": [
                {
                    "exact_snippets": "No gastrointestinal condition (e.g., peptic ulcer disease)",
                    "criterion": "gastrointestinal condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "that would affect absorption",
                    "criterion": "absorption",
                    "requirements": [
                        {
                            "requirement_type": "effect",
                            "expected_value": "not affected"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No serious infection",
            "criterions": [
                {
                    "exact_snippets": "No serious infection",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known severe hypersensitivity to gefitinib or any of its excipients",
            "criterions": [
                {
                    "exact_snippets": "No known severe hypersensitivity to gefitinib",
                    "criterion": "hypersensitivity to gefitinib",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "No known severe hypersensitivity to ... any of its excipients",
                    "criterion": "hypersensitivity to gefitinib excipients",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix",
            "criterions": [
                {
                    "exact_snippets": "No other malignancy within the past 5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except treated basal cell or squamous cell skin cancer",
                    "criterion": "treated basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other severe or uncontrolled systemic disease",
            "criterions": [
                {
                    "exact_snippets": "No other severe or uncontrolled systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No significant clinical disorder or laboratory finding that would preclude study participation",
            "criterions": [
                {
                    "exact_snippets": "No significant clinical disorder",
                    "criterion": "clinical disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "No significant ... laboratory finding",
                    "criterion": "laboratory finding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biologic therapy",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 14 days since prior biologic therapy",
            "criterions": [
                {
                    "exact_snippets": "More than 14 days since prior biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since prior treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior cetuximab, panitumumab, or bevacizumab",
            "criterions": [
                {
                    "exact_snippets": "No prior cetuximab",
                    "criterion": "prior cetuximab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... panitumumab",
                    "criterion": "prior panitumumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... bevacizumab",
                    "criterion": "prior bevacizumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior cytotoxic chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior cytotoxic chemotherapy",
                    "criterion": "time since prior cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 3 weeks since prior radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "More than 3 weeks since prior radiotherapy",
                    "criterion": "time since prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent radiotherapy",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovered from prior oncologic or other major surgery",
            "criterions": [
                {
                    "exact_snippets": "Recovered from prior oncologic or other major surgery",
                    "criterion": "recovery from prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior gastrointestinal surgery affecting absorption",
            "criterions": [
                {
                    "exact_snippets": "No prior gastrointestinal surgery affecting absorption",
                    "criterion": "prior gastrointestinal surgery",
                    "requirements": [
                        {
                            "requirement_type": "affecting absorption",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent surgery, including ophthalmic surgery, during and for 1 week after study treatment",
            "criterions": [
                {
                    "exact_snippets": "No concurrent surgery, including ophthalmic surgery, during and for 1 week after study treatment",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "during and for 1 week after study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovered from all prior therapy",
            "criterions": [
                {
                    "exact_snippets": "Recovered from all prior therapy",
                    "criterion": "recovery from prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 30 days since prior investigational agents",
            "criterions": [
                {
                    "exact_snippets": "More than 30 days since prior investigational agents",
                    "criterion": "time since prior investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior HER1/epidermal growth factor receptor axis agents, including the following:",
            "criterions": [
                {
                    "exact_snippets": "No other prior HER1/epidermal growth factor receptor axis agents",
                    "criterion": "prior HER1/epidermal growth factor receptor axis agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gefitinib",
            "criterions": [
                {
                    "exact_snippets": "Gefitinib",
                    "criterion": "Gefitinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Erlotinib",
            "criterions": [
                {
                    "exact_snippets": "Erlotinib",
                    "criterion": "Erlotinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CI-1033",
            "criterions": [
                {
                    "exact_snippets": "CI-1033",
                    "criterion": "CI-1033",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lapatinib",
            "criterions": [
                {
                    "exact_snippets": "Lapatinib",
                    "criterion": "Lapatinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior vascular endothelial growth factor axis agents, including the following:",
            "criterions": [
                {
                    "exact_snippets": "No other prior vascular endothelial growth factor axis agents",
                    "criterion": "prior vascular endothelial growth factor axis agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ZD6474",
            "criterions": [
                {
                    "exact_snippets": "ZD6474",
                    "criterion": "ZD6474",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vatalanib",
            "criterions": [
                {
                    "exact_snippets": "Vatalanib",
                    "criterion": "Vatalanib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent CYP3A4 inducers, including the following:",
            "criterions": [
                {
                    "exact_snippets": "No concurrent CYP3A4 inducers",
                    "criterion": "CYP3A4 inducers",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Phenytoin",
            "criterions": [
                {
                    "exact_snippets": "Phenytoin",
                    "criterion": "phenytoin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Carbamazepine",
            "criterions": [
                {
                    "exact_snippets": "Carbamazepine",
                    "criterion": "Carbamazepine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rifampin",
            "criterions": [
                {
                    "exact_snippets": "Rifampin",
                    "criterion": "Rifampin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Phenobarbital",
            "criterions": [
                {
                    "exact_snippets": "Phenobarbital",
                    "criterion": "Phenobarbital",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Barbiturates",
            "criterions": [
                {
                    "exact_snippets": "Barbiturates",
                    "criterion": "barbiturates",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypericum perforatum (St. John's wort)",
            "criterions": [
                {
                    "exact_snippets": "Hypericum perforatum (St. John's wort)",
                    "criterion": "Hypericum perforatum (St. John's wort)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent systemic treatment for the malignancy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent systemic treatment for the malignancy",
                    "criterion": "concurrent systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent bisphosphonates for symptomatic bone metastases",
            "criterions": [
                {
                    "exact_snippets": "No concurrent bisphosphonates for symptomatic bone metastases",
                    "criterion": "concurrent bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent bisphosphonates for symptomatic bone metastases",
                    "criterion": "symptomatic bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent systemic retinoids",
            "criterions": [
                {
                    "exact_snippets": "No concurrent systemic retinoids",
                    "criterion": "systemic retinoids",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        }
    ]
}