{
    "info": {
        "nct_id": "NCT01512420",
        "official_title": "A Multicenter, Prospective, Observational Study to Identify Different Prognostic Factors Related to Survival in Patients With Previously Treated Advanced NSCLC With Wild-type Epidermal Growth Factor Receptor (EGFR) Gene.",
        "inclusion_criteria": "* Adult patients, >/= 18 years of age\n* Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)\n* Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:\n* squamous cell carcinoma lung cancer histology, and\n* current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of >15 pack-years of smoking\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n* Patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Current treatment with an investigational drug or participation in another investigational study\n* Severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin\n* Clinically active interstitial lung disease\n* Recent myocardial infarction or unstable angina\n* Progressive or uncontrolled brain metastases",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adult patients, >/= 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Adult patients, >/= 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic non-small cell lung cancer (NSCLC)",
                    "criterion": "non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "known wild-type EGFR gene",
                    "criterion": "EGFR gene mutation status",
                    "requirements": [
                        {
                            "requirement_type": "mutation type",
                            "expected_value": "wild-type"
                        }
                    ]
                },
                {
                    "exact_snippets": "unknown EGFR mutation status",
                    "criterion": "EGFR gene mutation status",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "unknown"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* squamous cell carcinoma lung cancer histology, and",
            "criterions": [
                {
                    "exact_snippets": "squamous cell carcinoma lung cancer histology",
                    "criterion": "lung cancer histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "squamous cell carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of >15 pack-years of smoking",
            "criterions": [
                {
                    "exact_snippets": "current smoker",
                    "criterion": "smoking status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "current smoker"
                        }
                    ]
                },
                {
                    "exact_snippets": "former smoker who has stopped smoking less than 10 years ago",
                    "criterion": "smoking cessation duration",
                    "requirements": [
                        {
                            "requirement_type": "duration since cessation",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has had a total of >15 pack-years of smoking",
                    "criterion": "pack-years of smoking",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 15,
                                "unit": "pack-years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva",
            "criterions": [
                {
                    "exact_snippets": "Patients having failed one prior chemotherapy regimen",
                    "criterion": "prior chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "failure",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for a second-line treatment with Tarceva",
                    "criterion": "second-line treatment with Tarceva",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "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": "* Current treatment with an investigational drug or participation in another investigational study",
            "criterions": [
                {
                    "exact_snippets": "Current treatment with an investigational drug",
                    "criterion": "treatment with an investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participation in another investigational study",
                    "criterion": "participation in another investigational study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin",
            "criterions": [
                {
                    "exact_snippets": "Severe or uncontrolled systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concomitant malignancy",
                    "criterion": "concomitant malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "second primary malignancy",
                    "criterion": "second primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell carcinoma of the skin",
                    "criterion": "adequately treated basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically active interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "Clinically active interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "clinically active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recent myocardial infarction or unstable angina",
            "criterions": [
                {
                    "exact_snippets": "Recent myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive or uncontrolled brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Progressive or uncontrolled brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}