{
    "info": {
        "nct_id": "NCT00550173",
        "official_title": "A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer\n* Patients must be non-smokers\n* Patients must have at least one measurable lesion\n* Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale\n* Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication\n* Patients who have previously received treatment with drugs against the human epidermal growth factor receptors\n* Patients who have previously received treatment with drugs which have similar targets as Pemetrexed\n* Patients who have any known significant ophthalmologic abnormalities of the surface of the eye\n* Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer",
            "criterions": [
                {
                    "exact_snippets": "locally advanced or metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "nonsquamous non-small cell lung cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "nonsquamous non-small cell lung cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be non-smokers",
            "criterions": [
                {
                    "exact_snippets": "Patients must be non-smokers",
                    "criterion": "smoking status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-smoker"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have at least one measurable lesion",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale",
            "criterions": [
                {
                    "exact_snippets": "Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Eastern Cooperative Oncology Group Scale"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.",
            "criterions": [
                {
                    "exact_snippets": "failed only one prior chemotherapy regimen",
                    "criterion": "prior chemotherapy regimens failed",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "considered eligible for further chemotherapy",
                    "criterion": "eligibility for further chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "allowed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received treatment within the last 30 days",
                    "criterion": "recent treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "a drug that has not received regulatory approval for any indication",
                    "criterion": "drug approval status",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have previously received treatment with drugs against the human epidermal growth factor receptors",
            "criterions": [
                {
                    "exact_snippets": "previously received treatment with drugs against the human epidermal growth factor receptors",
                    "criterion": "treatment with drugs against the human epidermal growth factor receptors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have previously received treatment with drugs which have similar targets as Pemetrexed",
            "criterions": [
                {
                    "exact_snippets": "Patients who have previously received treatment with drugs which have similar targets as Pemetrexed",
                    "criterion": "previous treatment with drugs similar to Pemetrexed",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have any known significant ophthalmologic abnormalities of the surface of the eye",
            "criterions": [
                {
                    "exact_snippets": "any known significant ophthalmologic abnormalities of the surface of the eye",
                    "criterion": "ophthalmologic abnormalities of the surface of the eye",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed",
            "criterions": [
                {
                    "exact_snippets": "history of severe hypersensitivity reaction to erlotinib",
                    "criterion": "hypersensitivity reaction to erlotinib",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of severe hypersensitivity reaction to ... pemetrexed",
                    "criterion": "hypersensitivity reaction to pemetrexed",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}