{
    "info": {
        "nct_id": "NCT05955391",
        "official_title": "A Multi-centered, Open-label, Single-arm Phase II Study to Evaluate the Safety and Efficacy of TGRX-326 Monotherapy in Patients of Advanced ALK-positiveNon-Small Cell Lung Cancer Who Failed 2nd-Generation ALK Inhibitor Therapies",
        "inclusion_criteria": "1. Willing to follow the treatment protocol and visit schedule, and participate in the study with the ICF signed;\n2. ≥ 18 years of age on the day of ICF signing, regardless of gender.\n3. With ALK-positive advanced inoperable NSCLC and having disease progression or intolerance after continuous treatment with second-generation ALK inhibitors;\n4. Providing prior ALK positive test results at screening;\n5. Patients could have metastases to central nervous system at screening if the condition is asymptomatic, stable or completely recovered;\n6. Drug discontinuation for ≥ 5 half-lives prior to the first dose for subjects previously treated with ALK inhibitors;\n7. At least one measurable lesion;\n8. An ECOG PS score within 0-2;\n9. Adequate bone marrow, liver, kidney, coagulation and pancreatic functions;\n10. Expected survival ≥ 3 months;\n11. Willing to take effective contraceptive measures (for men of reproductive potential and women of reproductive age only) from ICF signing to 6 months after administration of the investigational drug. Women of reproductive age include women before menopause and within 2 years after menopause. Those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Previous use of any third-generation ALK inhibitors other than TGRX-326;\n2. Known hypersensitivity to any of the active ingredients or excipients of TGRX-326 or a history of severe allergic reactions that makes himself/herself unsuitable for TGRX-326 treatment in the judgment of the investigator;\n3. Having another type of cancer except for lung cancer;\n4. Major surgery within 4 weeks prior to the first dose;\n5. Spinal cord compression caused by tumor, unless the subject achieves significant pain control and full recovery of neurological function within 4 weeks prior to the first dose.\n6. Abnormal gastrointestinal function that affect absorption within the past 6 months;\n7. History of active pneumonia or clinically significant interstitial pneumonia, or radiation or drug-induced lung disorder with treatment needs;\n8. Cardiac insufficiency;\n9. Abnormal and clinically significant QTc on ECG or need of concomitant use of any drug known to prolong QT interval and cause torsades de pointes;\n10. Uncontrolled hypertension after drug treatment;\n11. Uncontrolled hyperglycaemia, acute attack of cholelithiasis, and susceptibility to acute pancreatitis;\n12. Severe or uncontrolled systemic diseases causing expected intolerance to the investigational drug as judged by the investigator;\n13. Use within 14 days before the first dose or expected concomitant use during the treatment period of drugs that pose risk of QTC interval prolongation and/or ventricular tachycardia;\n14. Previous antineoplastic treatments within 28 days prior to the first dose of the investigational drug;\n15. Toxic reactions associated with prior surgery and prior antineoplastic therapies that have not recovered and may affect the subject safety as assessed by the investigator.\n16. Clinically significant active bacterial, fungal or viral infections, including a positive result for hepatitis B surface antigen and HBV DNA ≥ ULN, one or more positive results for hepatitis C antibody or HIV antibody, or the presence of any uncontrolled infection.\n17. Use of strong CYP3A4 inducers or inhibitors or CYP3A4 substrates with a narrow therapeutic window within two weeks prior to the first dose of the investigational drug;\n18. Pregnant and breastfeeding female;\n19. Women of childbearing age who are unwilling or unable to use acceptable methods for contraception during the entire treatment period in the trial and within 6 months after the last dose of the investigational drug (women of childbearing age include: any one with menarche, and those who have not received successful artificial sterilization [hysterectomy, bilateral fallopian tube ligation, or bilateral oophorectomy] or premenopausal women); a fertile male patient who is unwilling or unable to take effective contraceptive measures, and whose partner is a woman of childbearing age;\n20. Being involved in other clinical studies (except for the non-interventional phase of interventional clinical study, such as survival follow-up period); less than 4 weeks from the end of the dose of other investigational drug to the first dose of the investigational drug or 5 half-lives of the previous drug, whichever is shorter;\n21. Any mental or cognitive disorders which may limit subjects' understanding and implementation of the informed consent form;\n22. Other situations, such as poor compliance, which are considered by the investigator to be not suitable for participation in the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "2. ≥ 18 years of age on the day of ICF signing, regardless of gender.",
                "criterions": [
                    {
                        "exact_snippets": "≥ 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "≥ 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. With ALK-positive advanced inoperable NSCLC and having disease progression or intolerance after continuous treatment with second-generation ALK inhibitors;",
                "criterions": [
                    {
                        "exact_snippets": "ALK-positive advanced inoperable NSCLC",
                        "criterion": "NSCLC",
                        "requirement": {
                            "requirement_type": "ALK status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "ALK-positive advanced inoperable NSCLC",
                        "criterion": "NSCLC",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    },
                    {
                        "exact_snippets": "ALK-positive advanced inoperable NSCLC",
                        "criterion": "NSCLC",
                        "requirement": {
                            "requirement_type": "operability",
                            "expected_value": "inoperable"
                        }
                    },
                    {
                        "exact_snippets": "having disease progression or intolerance after continuous treatment with second-generation ALK inhibitors",
                        "criterion": "treatment history with second-generation ALK inhibitors",
                        "requirement": {
                            "requirement_type": "disease progression or intolerance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "ALK-positive advanced inoperable NSCLC",
                                        "criterion": "NSCLC",
                                        "requirement": {
                                            "requirement_type": "ALK status",
                                            "expected_value": "positive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "ALK-positive advanced inoperable NSCLC",
                                        "criterion": "NSCLC",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "advanced"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "ALK-positive advanced inoperable NSCLC",
                                "criterion": "NSCLC",
                                "requirement": {
                                    "requirement_type": "operability",
                                    "expected_value": "inoperable"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "having disease progression or intolerance after continuous treatment with second-generation ALK inhibitors",
                        "criterion": "treatment history with second-generation ALK inhibitors",
                        "requirement": {
                            "requirement_type": "disease progression or intolerance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Providing prior ALK positive test results at screening;",
                "criterions": [
                    {
                        "exact_snippets": "prior ALK positive test results",
                        "criterion": "ALK test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "prior ALK positive test results",
                        "criterion": "ALK test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Patients could have metastases to central nervous system at screening if the condition is asymptomatic, stable or completely recovered;",
                "criterions": [
                    {
                        "exact_snippets": "metastases to central nervous system",
                        "criterion": "metastases to central nervous system",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": [
                                "asymptomatic",
                                "stable",
                                "completely recovered"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "metastases to central nervous system",
                        "criterion": "metastases to central nervous system",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": [
                                "asymptomatic",
                                "stable",
                                "completely recovered"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Drug discontinuation for ≥ 5 half-lives prior to the first dose for subjects previously treated with ALK inhibitors;",
                "criterions": [
                    {
                        "exact_snippets": "Drug discontinuation for ≥ 5 half-lives prior to the first dose for subjects previously treated with ALK inhibitors",
                        "criterion": "drug discontinuation",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Drug discontinuation for ≥ 5 half-lives prior to the first dose for subjects previously treated with ALK inhibitors",
                        "criterion": "drug discontinuation",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Drug discontinuation for ≥ 5 half-lives prior to the first dose for subjects previously treated with ALK inhibitors",
                        "criterion": "previous treatment with ALK inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. At least one measurable lesion;",
                "criterions": [
                    {
                        "exact_snippets": "At least one measurable lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least one measurable lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. An ECOG PS score within 0-2;",
                "criterions": [
                    {
                        "exact_snippets": "ECOG PS score within 0-2",
                        "criterion": "ECOG PS score",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG PS score within 0-2",
                        "criterion": "ECOG PS score",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Adequate bone marrow, liver, kidney, coagulation and pancreatic functions;",
                "criterions": [
                    {
                        "exact_snippets": "Adequate bone marrow ... functions",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... liver ... functions",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... kidney ... functions",
                        "criterion": "kidney function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... coagulation ... functions",
                        "criterion": "coagulation function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... pancreatic functions",
                        "criterion": "pancreatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate bone marrow ... functions",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... liver ... functions",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... kidney ... functions",
                        "criterion": "kidney function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... coagulation ... functions",
                        "criterion": "coagulation function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... pancreatic functions",
                        "criterion": "pancreatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Expected survival ≥ 3 months;",
                "criterions": [
                    {
                        "exact_snippets": "Expected survival ≥ 3 months",
                        "criterion": "expected survival",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Expected survival ≥ 3 months",
                        "criterion": "expected survival",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Willing to take effective contraceptive measures (for men of reproductive potential and women of reproductive age only) from ICF signing to 6 months after administration of the investigational drug. Women of reproductive age include women before menopause and within 2 years after menopause. Those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug.",
                "criterions": [
                    {
                        "exact_snippets": "Willing to take effective contraceptive measures (for men of reproductive potential and women of reproductive age only)",
                        "criterion": "contraceptive measures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Women of reproductive age include women before menopause and within 2 years after menopause.",
                        "criterion": "reproductive age",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "women before menopause and within 2 years after menopause"
                        }
                    },
                    {
                        "exact_snippets": "Those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug.",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug.",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Willing to take effective contraceptive measures (for men of reproductive potential and women of reproductive age only)",
                                    "criterion": "contraceptive measures",
                                    "requirement": {
                                        "requirement_type": "willingness",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "Women of reproductive age include women before menopause and within 2 years after menopause.",
                                    "criterion": "reproductive age",
                                    "requirement": {
                                        "requirement_type": "definition",
                                        "expected_value": "women before menopause and within 2 years after menopause"
                                    }
                                }
                            ]
                        },
                        {
                            "exact_snippets": "Willing to take effective contraceptive measures (for men of reproductive potential and women of reproductive age only)",
                            "criterion": "contraceptive measures",
                            "requirement": {
                                "requirement_type": "willingness",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug.",
                            "criterion": "pregnancy test",
                            "requirement": {
                                "requirement_type": "result",
                                "expected_value": "negative"
                            }
                        },
                        {
                            "exact_snippets": "Those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug.",
                            "criterion": "pregnancy test",
                            "requirement": {
                                "requirement_type": "timing",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 7,
                                    "unit": "days"
                                }
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Willing to follow the treatment protocol and visit schedule, and participate in the study with the ICF signed;",
                "criterions": [
                    {
                        "exact_snippets": "Willing to follow the treatment protocol",
                        "criterion": "willingness to follow treatment protocol",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing to follow the ... visit schedule",
                        "criterion": "willingness to follow visit schedule",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "participate in the study",
                        "criterion": "willingness to participate in the study",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ICF signed",
                        "criterion": "informed consent form",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willing to follow the treatment protocol",
                        "criterion": "willingness to follow treatment protocol",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing to follow the ... visit schedule",
                        "criterion": "willingness to follow visit schedule",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "participate in the study",
                        "criterion": "willingness to participate in the study",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ICF signed",
                        "criterion": "informed consent form",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Previous use of any third-generation ALK inhibitors other than TGRX-326;",
                "criterions": [
                    {
                        "exact_snippets": "Previous use of any third-generation ALK inhibitors other than TGRX-326",
                        "criterion": "use of third-generation ALK inhibitors",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Previous use of any third-generation ALK inhibitors other than TGRX-326",
                            "criterion": "use of third-generation ALK inhibitors",
                            "requirement": {
                                "requirement_type": "exclusion",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Known hypersensitivity to any of the active ingredients or excipients of TGRX-326 or a history of severe allergic reactions that makes himself/herself unsuitable for TGRX-326 treatment in the judgment of the investigator;",
                "criterions": [
                    {
                        "exact_snippets": "Known hypersensitivity to any of the active ingredients or excipients of TGRX-326",
                        "criterion": "hypersensitivity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "a history of severe allergic reactions that makes himself/herself unsuitable for TGRX-326 treatment in the judgment of the investigator",
                        "criterion": "severe allergic reactions",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known hypersensitivity to any of the active ingredients or excipients of TGRX-326",
                        "criterion": "hypersensitivity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "a history of severe allergic reactions that makes himself/herself unsuitable for TGRX-326 treatment in the judgment of the investigator",
                        "criterion": "severe allergic reactions",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Cardiac insufficiency;",
                "criterions": [
                    {
                        "exact_snippets": "Cardiac insufficiency",
                        "criterion": "cardiac insufficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Cardiac insufficiency",
                    "criterion": "cardiac insufficiency",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Abnormal and clinically significant QTc on ECG or need of concomitant use of any drug known to prolong QT interval and cause torsades de pointes;",
                "criterions": [
                    {
                        "exact_snippets": "Abnormal and clinically significant QTc on ECG",
                        "criterion": "QTc on ECG",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Abnormal and clinically significant QTc on ECG",
                        "criterion": "QTc on ECG",
                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "need of concomitant use of any drug known to prolong QT interval",
                        "criterion": "concomitant use of drug known to prolong QT interval",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "drug known to ... cause torsades de pointes",
                        "criterion": "drug known to cause torsades de pointes",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Abnormal and clinically significant QTc on ECG",
                                "criterion": "QTc on ECG",
                                "requirement": {
                                    "requirement_type": "abnormality",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Abnormal and clinically significant QTc on ECG",
                                "criterion": "QTc on ECG",
                                "requirement": {
                                    "requirement_type": "clinical significance",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "need of concomitant use of any drug known to prolong QT interval",
                                "criterion": "concomitant use of drug known to prolong QT interval",
                                "requirement": {
                                    "requirement_type": "necessity",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "drug known to ... cause torsades de pointes",
                                "criterion": "drug known to cause torsades de pointes",
                                "requirement": {
                                    "requirement_type": "necessity",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Uncontrolled hypertension after drug treatment;",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled hypertension after drug treatment",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled hypertension after drug treatment",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "after drug treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled hypertension after drug treatment",
                                "criterion": "hypertension",
                                "requirement": {
                                    "requirement_type": "control status",
                                    "expected_value": "uncontrolled"
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled hypertension after drug treatment",
                                "criterion": "hypertension",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "after drug treatment"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Uncontrolled hyperglycaemia, acute attack of cholelithiasis, and susceptibility to acute pancreatitis;",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled hyperglycaemia",
                        "criterion": "hyperglycaemia",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "acute attack of cholelithiasis",
                        "criterion": "cholelithiasis",
                        "requirement": {
                            "requirement_type": "attack",
                            "expected_value": "acute"
                        }
                    },
                    {
                        "exact_snippets": "susceptibility to acute pancreatitis",
                        "criterion": "pancreatitis",
                        "requirement": {
                            "requirement_type": "susceptibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "susceptibility to acute pancreatitis",
                        "criterion": "pancreatitis",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "acute"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled hyperglycaemia",
                                "criterion": "hyperglycaemia",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "uncontrolled"
                                }
                            },
                            {
                                "exact_snippets": "acute attack of cholelithiasis",
                                "criterion": "cholelithiasis",
                                "requirement": {
                                    "requirement_type": "attack",
                                    "expected_value": "acute"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "susceptibility to acute pancreatitis",
                                "criterion": "pancreatitis",
                                "requirement": {
                                    "requirement_type": "susceptibility",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "susceptibility to acute pancreatitis",
                                "criterion": "pancreatitis",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "acute"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Severe or uncontrolled systemic diseases causing expected intolerance to the investigational drug as judged by the investigator;",
                "criterions": [
                    {
                        "exact_snippets": "Severe or uncontrolled systemic diseases",
                        "criterion": "systemic diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Severe or uncontrolled systemic diseases",
                        "criterion": "systemic diseases",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "causing expected intolerance to the investigational drug",
                        "criterion": "intolerance to investigational drug",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": "systemic diseases"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Severe or uncontrolled systemic diseases",
                                "criterion": "systemic diseases",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "Severe or uncontrolled systemic diseases",
                                "criterion": "systemic diseases",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "causing expected intolerance to the investigational drug",
                        "criterion": "intolerance to investigational drug",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": "systemic diseases"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Use within 14 days before the first dose or expected concomitant use during the treatment period of drugs that pose risk of QTC interval prolongation and/or ventricular tachycardia;",
                "criterions": [
                    {
                        "exact_snippets": "Use within 14 days before the first dose or expected concomitant use during the treatment period of drugs that pose risk of QTC interval prolongation",
                        "criterion": "use of drugs that pose risk of QTC interval prolongation",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days before the first dose or during the treatment period"
                        }
                    },
                    {
                        "exact_snippets": "Use within 14 days before the first dose or expected concomitant use during the treatment period of drugs that pose risk of ... ventricular tachycardia",
                        "criterion": "use of drugs that pose risk of ventricular tachycardia",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days before the first dose or during the treatment period"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Use within 14 days before the first dose or expected concomitant use during the treatment period of drugs that pose risk of QTC interval prolongation",
                                "criterion": "use of drugs that pose risk of QTC interval prolongation",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 14 days before the first dose or during the treatment period"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Use within 14 days before the first dose or expected concomitant use during the treatment period of drugs that pose risk of ... ventricular tachycardia",
                                "criterion": "use of drugs that pose risk of ventricular tachycardia",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 14 days before the first dose or during the treatment period"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Previous antineoplastic treatments within 28 days prior to the first dose of the investigational drug;",
                "criterions": [
                    {
                        "exact_snippets": "Previous antineoplastic treatments within 28 days prior to the first dose of the investigational drug",
                        "criterion": "previous antineoplastic treatments",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Previous antineoplastic treatments within 28 days prior to the first dose of the investigational drug",
                    "criterion": "previous antineoplastic treatments",
                    "requirement": {
                        "requirement_type": "time since last treatment",
                        "expected_value": {
                            "operator": ">=",
                            "value": 28,
                            "unit": "days"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "15. Toxic reactions associated with prior surgery and prior antineoplastic therapies that have not recovered and may affect the subject safety as assessed by the investigator.",
                "criterions": [
                    {
                        "exact_snippets": "Toxic reactions associated with prior surgery",
                        "criterion": "toxic reactions from prior surgery",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": "not recovered"
                        }
                    },
                    {
                        "exact_snippets": "Toxic reactions associated with prior surgery",
                        "criterion": "toxic reactions from prior surgery",
                        "requirement": {
                            "requirement_type": "impact on subject safety",
                            "expected_value": "may affect"
                        }
                    },
                    {
                        "exact_snippets": "Toxic reactions associated with ... prior antineoplastic therapies",
                        "criterion": "toxic reactions from prior antineoplastic therapies",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": "not recovered"
                        }
                    },
                    {
                        "exact_snippets": "Toxic reactions associated with ... prior antineoplastic therapies",
                        "criterion": "toxic reactions from prior antineoplastic therapies",
                        "requirement": {
                            "requirement_type": "impact on subject safety",
                            "expected_value": "may affect"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Toxic reactions associated with prior surgery",
                                        "criterion": "toxic reactions from prior surgery",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": "not recovered"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Toxic reactions associated with prior surgery",
                                        "criterion": "toxic reactions from prior surgery",
                                        "requirement": {
                                            "requirement_type": "impact on subject safety",
                                            "expected_value": "may affect"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Toxic reactions associated with ... prior antineoplastic therapies",
                                        "criterion": "toxic reactions from prior antineoplastic therapies",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": "not recovered"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Toxic reactions associated with ... prior antineoplastic therapies",
                                        "criterion": "toxic reactions from prior antineoplastic therapies",
                                        "requirement": {
                                            "requirement_type": "impact on subject safety",
                                            "expected_value": "may affect"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "16. Clinically significant active bacterial, fungal or viral infections, including a positive result for hepatitis B surface antigen and HBV DNA ≥ ULN, one or more positive results for hepatitis C antibody or HIV antibody, or the presence of any uncontrolled infection.",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant active bacterial, fungal or viral infections",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive result for hepatitis B surface antigen",
                        "criterion": "hepatitis B surface antigen",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "HBV DNA ≥ ULN",
                        "criterion": "HBV DNA",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "one or more positive results for hepatitis C antibody",
                        "criterion": "hepatitis C antibody",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "one or more positive results for ... HIV antibody",
                        "criterion": "HIV antibody",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "presence of any uncontrolled infection",
                        "criterion": "uncontrolled infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Clinically significant active bacterial, fungal or viral infections",
                                "criterion": "active infections",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "presence of any uncontrolled infection",
                                "criterion": "uncontrolled infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "positive result for hepatitis B surface antigen",
                        "criterion": "hepatitis B surface antigen",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "HBV DNA ≥ ULN",
                                "criterion": "HBV DNA",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "positive result for hepatitis B surface antigen",
                                "criterion": "hepatitis B surface antigen",
                                "requirement": {
                                    "requirement_type": "result",
                                    "expected_value": "positive"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "one or more positive results for hepatitis C antibody",
                        "criterion": "hepatitis C antibody",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "one or more positive results for ... HIV antibody",
                        "criterion": "HIV antibody",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "17. Use of strong CYP3A4 inducers or inhibitors or CYP3A4 substrates with a narrow therapeutic window within two weeks prior to the first dose of the investigational drug;",
                "criterions": [
                    {
                        "exact_snippets": "Use of strong CYP3A4 inducers",
                        "criterion": "use of strong CYP3A4 inducers",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within two weeks prior to the first dose of the investigational drug"
                        }
                    },
                    {
                        "exact_snippets": "Use of strong CYP3A4 ... inhibitors",
                        "criterion": "use of strong CYP3A4 inhibitors",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within two weeks prior to the first dose of the investigational drug"
                        }
                    },
                    {
                        "exact_snippets": "Use of ... CYP3A4 substrates with a narrow therapeutic window",
                        "criterion": "use of CYP3A4 substrates with a narrow therapeutic window",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within two weeks prior to the first dose of the investigational drug"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Use of strong CYP3A4 inducers",
                        "criterion": "use of strong CYP3A4 inducers",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within two weeks prior to the first dose of the investigational drug"
                        }
                    },
                    {
                        "exact_snippets": "Use of strong CYP3A4 ... inhibitors",
                        "criterion": "use of strong CYP3A4 inhibitors",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within two weeks prior to the first dose of the investigational drug"
                        }
                    },
                    {
                        "exact_snippets": "Use of ... CYP3A4 substrates with a narrow therapeutic window",
                        "criterion": "use of CYP3A4 substrates with a narrow therapeutic window",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within two weeks prior to the first dose of the investigational drug"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "18. Pregnant and breastfeeding female;",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding female",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding female",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "3. Having another type of cancer except for lung cancer;",
                "criterions": [
                    {
                        "exact_snippets": "Having another type of cancer except for lung cancer",
                        "criterion": "type of cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "any type except lung cancer"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
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            }
        },
        {
            "identified_line": {
                "line": "4. Major surgery within 4 weeks prior to the first dose;",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 4 weeks prior to the first dose",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Spinal cord compression caused by tumor, unless the subject achieves significant pain control and full recovery of neurological function within 4 weeks prior to the first dose.",
                "criterions": [
                    {
                        "exact_snippets": "Spinal cord compression caused by tumor",
                        "criterion": "spinal cord compression",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": "tumor"
                        }
                    },
                    {
                        "exact_snippets": "significant pain control",
                        "criterion": "pain control",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "full recovery of neurological function",
                        "criterion": "neurological function",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": "full"
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks prior to the first dose",
                        "criterion": "timeframe for recovery",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Abnormal gastrointestinal function that affect absorption within the past 6 months;",
                "criterions": [
                    {
                        "exact_snippets": "Abnormal gastrointestinal function",
                        "criterion": "gastrointestinal function",
                        "requirement": {
                            "requirement_type": "normality",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "affect absorption",
                        "criterion": "absorption",
                        "requirement": {
                            "requirement_type": "impact",
                            "expected_value": "affected"
                        }
                    },
                    {
                        "exact_snippets": "within the past 6 months",
                        "criterion": "time since abnormal gastrointestinal function",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. History of active pneumonia or clinically significant interstitial pneumonia, or radiation or drug-induced lung disorder with treatment needs;",
                "criterions": [
                    {
                        "exact_snippets": "History of active pneumonia",
                        "criterion": "active pneumonia",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "clinically significant interstitial pneumonia",
                        "criterion": "interstitial pneumonia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "radiation or drug-induced lung disorder with treatment needs",
                        "criterion": "lung disorder",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": [
                                "radiation",
                                "drug-induced"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "radiation or drug-induced lung disorder with treatment needs",
                        "criterion": "lung disorder",
                        "requirement": {
                            "requirement_type": "treatment needs",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "19. Women of childbearing age who are unwilling or unable to use acceptable methods for contraception during the entire treatment period in the trial and within 6 months after the last dose of the investigational drug (women of childbearing age include: any one with menarche, and those who have not received successful artificial sterilization [hysterectomy, bilateral fallopian tube ligation, or bilateral oophorectomy] or premenopausal women); a fertile male patient who is unwilling or unable to take effective contraceptive measures, and whose partner is a woman of childbearing age;",
                "criterions": [
                    {
                        "exact_snippets": "Women of childbearing age",
                        "criterion": "women of childbearing age",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unwilling or unable to use acceptable methods for contraception during the entire treatment period in the trial and within 6 months after the last dose of the investigational drug",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unwilling or unable to use acceptable methods for contraception during the entire treatment period in the trial and within 6 months after the last dose of the investigational drug",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "fertile male patient who is unwilling or unable to take effective contraceptive measures",
                        "criterion": "fertile male contraception use",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "fertile male patient who is unwilling or unable to take effective contraceptive measures",
                        "criterion": "fertile male contraception use",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "20. Being involved in other clinical studies (except for the non-interventional phase of interventional clinical study, such as survival follow-up period); less than 4 weeks from the end of the dose of other investigational drug to the first dose of the investigational drug or 5 half-lives of the previous drug, whichever is shorter;",
                "criterions": [
                    {
                        "exact_snippets": "Being involved in other clinical studies",
                        "criterion": "involvement in other clinical studies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "less than 4 weeks from the end of the dose of other investigational drug to the first dose of the investigational drug",
                        "criterion": "time since last dose of other investigational drug",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "5 half-lives of the previous drug",
                        "criterion": "time since last dose of other investigational drug",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "21. Any mental or cognitive disorders which may limit subjects' understanding and implementation of the informed consent form;",
                "criterions": [
                    {
                        "exact_snippets": "mental or cognitive disorders which may limit subjects' understanding and implementation of the informed consent form",
                        "criterion": "mental or cognitive disorders",
                        "requirement": {
                            "requirement_type": "impact on understanding and implementation",
                            "expected_value": "may limit"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "22. Other situations, such as poor compliance, which are considered by the investigator to be not suitable for participation in the study.",
                "criterions": [
                    {
                        "exact_snippets": "poor compliance",
                        "criterion": "compliance",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": "not suitable for participation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}