{
    "info": {
        "nct_id": "NCT00654420",
        "official_title": "An Open Label, Randomized Phase I/IIa Trial Evaluating MK-0646 in Combination With Erlotinib (TARCEVA™) for Patients With Recurrent Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* Participant has locally advanced or metastatic stage IIIB/IV NSCLC that has relapsed after hemotherapy/chemoratiotherapy\n* Participant has had at least one chemotherapy regimen for recurrent or metastatic disease\n* Participant is 18 years of age or older\n* Participant has a performance status of 0-2 on Eastern Cooperative Group (ECOG) scale\n* Women of childbearing potential have a negative pregnancy test\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participant has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks\n* Participant has not recovered from adverse events from previous therapy within 4 weeks\n* Participant has received EGFR-Tyrosine Kinase Inhibitor (TKI) inhibitor/anti-EGFR mAb therapy\n* Participant has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy\n* Participant has had more than 2 systemic chemotherapies for metastatic disease\n* Participant has not completed radiotherapy with complete resolution of toxicities at least 2 weeks before starting in the study\n* Participant is taking part in another clinical study\n* Participant has a primary central nervous system tumor\n* Participant abuses drugs or alcohol\n* Participant is pregnant or breastfeeding\n* Participant is Human Immunodeficiency Virus (HIV) positive\n* Participant has a history of hepatitis B or C\n* Participant is using growth hormone or growth hormone inhibitors",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
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                "line": "* Participant has locally advanced or metastatic stage IIIB/IV NSCLC that has relapsed after hemotherapy/chemoratiotherapy",
                "criterions": [
                    {
                        "exact_snippets": "locally advanced or metastatic stage IIIB/IV NSCLC",
                        "criterion": "NSCLC stage",
                        "requirement": {
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                            "expected_value": [
                                "IIIB",
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                            ]
                        }
                    },
                    {
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                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "relapsed after hemotherapy/chemoratiotherapy",
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                        "requirement": {
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "relapsed after hemotherapy/chemoratiotherapy",
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                        "requirement": {
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                                "chemotherapy",
                                "chemoradiotherapy"
                            ]
                        }
                    }
                ]
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                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
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                            {
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                                    {
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                                        }
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                                                "chemotherapy",
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                                    }
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                        ]
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                ]
            }
        },
        {
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                "line": "* Participant is 18 years of age or older",
                "criterions": [
                    {
                        "exact_snippets": "Participant is 18 years of age or older",
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                                "unit": "years"
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        },
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                "line": "* Participant has a performance status of 0-2 on Eastern Cooperative Group (ECOG) scale",
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                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
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                        }
                    }
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                                        "unit": "N/A"
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                                    {
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                                        "unit": "N/A"
                                    }
                                ]
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                        }
                    }
                ]
            }
        },
        {
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                "line": "* Women of childbearing potential have a negative pregnancy test",
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                        "exact_snippets": "Women of childbearing potential ... negative pregnancy test",
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                        "requirement": {
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                            "expected_value": "negative"
                        }
                    }
                ]
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                    {
                        "exact_snippets": "Women of childbearing potential ... negative pregnancy test",
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                ]
            }
        },
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            "identified_line": {
                "line": "Healthy volunteers allowed",
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
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                "and_criteria": [
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                        "exact_snippets": "Healthy volunteers allowed",
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                ]
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        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
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                    {
                        "exact_snippets": "minimum age of 18 Years",
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                                "unit": "Years"
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                        }
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                ]
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                    {
                        "exact_snippets": "minimum age of 18 Years",
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                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
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                "line": "* Participant has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks",
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                    {
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                                "unit": "weeks"
                            }
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                        "exact_snippets": "biological therapy (e.g. bevacizumab) within 4 weeks",
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                ]
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                                "unit": "weeks"
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        },
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            "identified_line": {
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                        }
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                        "exact_snippets": "Participant has received ... anti-EGFR mAb therapy",
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                        }
                    }
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            "identified_line": {
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                            "requirement_type": "quantity",
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                                "unit": "N/A"
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            "identified_line": {
                "line": "* Participant has not completed radiotherapy with complete resolution of toxicities at least 2 weeks before starting in the study",
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                                "unit": "weeks"
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                        "exact_snippets": "Participant abuses ... alcohol",
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                        "exact_snippets": "Participant abuses drugs",
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                        "exact_snippets": "Participant abuses ... alcohol",
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                        "exact_snippets": "Participant is using ... growth hormone inhibitors",
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                        }
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                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Participant is pregnant or breastfeeding",
                "criterions": [
                    {
                        "exact_snippets": "Participant is pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Participant is pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}