{
    "info": {
        "nct_id": "NCT04894591",
        "official_title": "Jazz Emerge 402: Phase IV Observational Study to Collect Safety and Outcome Data in Real-World Setting in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Zepzelca",
        "inclusion_criteria": "1. Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.\n2. Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.\n3. Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.\n4. Patients initiating Zepzelca treatment in second-line.\n5. Patients who are sensitive to platinum-based chemotherapy with CTFI≥180 days. The CTFI is defined as the length of time from last platinum dose to time of relapse or disease progression.\n6. Eastern Cooperative Oncology Group performance status (ECOG) ≤1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients who discontinued a prior Zepzelca treatment due to adverse events.\n2. Patient who received more than 2 cycles of Zepzelca treatment in their current treatment schedule.\n3. Patient received treatment with any investigational agent within 30 days prior to first Zepzelca infusion or plans to use another investigational agent while receiving Zepzelca.\n4. Known CNS involvement prior to Zepzelca treatment.\n5. Patients who were treated with Zepzelca in later lines rather than in second-line treatment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.",
            "criterions": [
                {
                    "exact_snippets": "Patient has initiated or will be receiving Zepzelca treatment",
                    "criterion": "Zepzelca treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "initiated or will be receiving"
                        }
                    ]
                },
                {
                    "exact_snippets": "in line with the local Zepzelca prescribing information",
                    "criterion": "Zepzelca prescribing information",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": "in line with local prescribing information"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.",
            "criterions": [
                {
                    "exact_snippets": "Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.",
                    "criterion": "treatment decision with Zepzelca",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.",
            "criterions": [
                {
                    "exact_snippets": "Patient, or a legally acceptable representative, signed the informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients initiating Zepzelca treatment in second-line.",
            "criterions": [
                {
                    "exact_snippets": "Patients initiating Zepzelca treatment",
                    "criterion": "Zepzelca treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "second-line",
                    "criterion": "treatment line",
                    "requirements": [
                        {
                            "requirement_type": "line",
                            "expected_value": "second-line"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients who are sensitive to platinum-based chemotherapy with CTFI≥180 days. The CTFI is defined as the length of time from last platinum dose to time of relapse or disease progression.",
            "criterions": [
                {
                    "exact_snippets": "sensitive to platinum-based chemotherapy",
                    "criterion": "sensitivity to platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CTFI≥180 days",
                    "criterion": "CTFI",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 180,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group performance status (ECOG) ≤1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status (ECOG) ≤1",
                    "criterion": "Eastern Cooperative Oncology Group performance status (ECOG)",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Patients who discontinued a prior Zepzelca treatment due to adverse events.",
            "criterions": [
                {
                    "exact_snippets": "discontinued a prior Zepzelca treatment due to adverse events",
                    "criterion": "prior Zepzelca treatment",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation reason",
                            "expected_value": "adverse events"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient who received more than 2 cycles of Zepzelca treatment in their current treatment schedule.",
            "criterions": [
                {
                    "exact_snippets": "Patient who received more than 2 cycles of Zepzelca treatment",
                    "criterion": "Zepzelca treatment cycles",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cycles"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient received treatment with any investigational agent within 30 days prior to first Zepzelca infusion or plans to use another investigational agent while receiving Zepzelca.",
            "criterions": [
                {
                    "exact_snippets": "Patient received treatment with any investigational agent within 30 days prior to first Zepzelca infusion",
                    "criterion": "treatment with investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "plans to use another investigational agent while receiving Zepzelca",
                    "criterion": "use of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Known CNS involvement prior to Zepzelca treatment.",
            "criterions": [
                {
                    "exact_snippets": "Known CNS involvement",
                    "criterion": "CNS involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients who were treated with Zepzelca in later lines rather than in second-line treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients who were treated with Zepzelca in later lines rather than in second-line treatment",
                    "criterion": "Zepzelca treatment line",
                    "requirements": [
                        {
                            "requirement_type": "treatment line",
                            "expected_value": "later lines rather than in second-line"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}