{
    "info": {
        "nct_id": "NCT02941601",
        "official_title": "A Multicenter, Phase 2 Study of Gemcitabine-Carboplatin Plus Necitumumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)",
        "inclusion_criteria": "* Have confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1 and metastatic NSCLC in Cohort 2, predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report.\n* Participants in Cohort 1 are required to have epidermal growth factor receptor (EGFR) protein expressing tumor (defined by local immunohistochemistry test). This is not required for participants in Cohort 2.\n* Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)\n* The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1\n* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks; Chest radiotherapy ≥4 weeks; Major surgery, excluding biopsy ≥4 weeks)\n* The participant has archived tumor tissue available for biomarker analyses.\n* Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous NSCLC.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* The participant has nonsquamous NSCLC\n* The participant has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.\n* The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy).\n* The participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.\n* The participant has a bleeding tumor.\n* The participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment.\n* The participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current ≥ Class III as defined by the New York Heart Association.\n* The participant has experienced myocardial infarction within 6 months prior to study enrollment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Have confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1 and metastatic NSCLC in Cohort 2, predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report.",
            "criterions": [
                {
                    "exact_snippets": "confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1",
                    "criterion": "NSCLC diagnosis in Cohort 1",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic NSCLC in Cohort 2",
                    "criterion": "NSCLC diagnosis in Cohort 2",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "predominantly squamous histology",
                    "criterion": "NSCLC histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "predominantly squamous"
                        }
                    ]
                },
                {
                    "exact_snippets": "Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report",
                    "criterion": "Squamous NSCLC diagnosis confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histology",
                                "cytology"
                            ]
                        },
                        {
                            "requirement_type": "source",
                            "expected_value": "local pathology report"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants in Cohort 1 are required to have epidermal growth factor receptor (EGFR) protein expressing tumor (defined by local immunohistochemistry test). This is not required for participants in Cohort 2.",
            "criterions": [
                {
                    "exact_snippets": "epidermal growth factor receptor (EGFR) protein expressing tumor",
                    "criterion": "EGFR protein expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease at the time of study entry",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks; Chest radiotherapy ≥4 weeks; Major surgery, excluding biopsy ≥4 weeks)",
            "criterions": [
                {
                    "exact_snippets": "discontinued all previous treatments for cancer",
                    "criterion": "previous cancer treatments",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered from the acute effects of therapy",
                    "criterion": "recovery from acute effects of therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks",
                    "criterion": "biologic agents and immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Chest radiotherapy ≥4 weeks",
                    "criterion": "chest radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Major surgery, excluding biopsy ≥4 weeks",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has archived tumor tissue available for biomarker analyses.",
            "criterions": [
                {
                    "exact_snippets": "archived tumor tissue available",
                    "criterion": "archived tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous NSCLC.",
            "criterions": [
                {
                    "exact_snippets": "Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor",
                    "criterion": "prior treatment with immune checkpoint inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "single-agent"
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous NSCLC",
                    "criterion": "squamous NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* The participant has nonsquamous NSCLC",
            "criterions": [
                {
                    "exact_snippets": "nonsquamous NSCLC",
                    "criterion": "NSCLC type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "nonsquamous"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.",
            "criterions": [
                {
                    "exact_snippets": "The participant has received prior anticancer therapy targeting the EGFR",
                    "criterion": "prior anticancer therapy targeting EGFR",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The participant has received prior anticancer therapy targeting the ... vascular endothelial growth factor (VEGF)",
                    "criterion": "prior anticancer therapy targeting VEGF",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The participant has received prior anticancer therapy targeting the ... VEGF receptor",
                    "criterion": "prior anticancer therapy targeting VEGF receptor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy).",
            "criterions": [
                {
                    "exact_snippets": "The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC",
                    "criterion": "previous chemotherapy for advanced NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy",
                    "criterion": "neo-adjuvant and/or adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases that are symptomatic",
                    "criterion": "symptomatic brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases that ... require ongoing treatment with steroids",
                    "criterion": "ongoing steroid treatment for brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases that ... require ongoing treatment with ... anticonvulsants",
                    "criterion": "ongoing anticonvulsant treatment for brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has a bleeding tumor.",
            "criterions": [
                {
                    "exact_snippets": "bleeding tumor",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "bleeding"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "history of arterial or venous thromboembolism within 3 months prior to study enrollment",
                    "criterion": "thromboembolism history",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 months prior to study enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current ≥ Class III as defined by the New York Heart Association.",
            "criterions": [
                {
                    "exact_snippets": "history or evidence of current clinically-relevant coronary artery disease ... ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Class III"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure of current ≥ Class III as defined by the New York Heart Association",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Class III"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has experienced myocardial infarction within 6 months prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "myocardial infarction within 6 months prior to study enrollment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}