{
    "info": {
        "nct_id": "NCT05548348",
        "official_title": "A Single Arm, Multicenter Study of First-line Furmonertinib Treatment in Patients With Advanced Epidermal Growth Factor Receptor Uncommon Mutation Positive Non-small Cell Lung Cancer",
        "inclusion_criteria": "* Provide informed consent prior to any study specific procedures;\n* 18 -70 years of age;\n* ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks, life expectancy ≥12 weeks;\n* Pathologically confirmed Non-Small Cell Lung Cancer (NSCLC);\n* Locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy (stage IIIB-IV, according to the 8th edition of the AJCC staging system);\n* Patient with EGFR G719X or S768I or L861Q mutation diagnosed histologically or cytologically, the reports must be issued or recognized by Tier 3A hospitals. The mutations above may exist alone or together;\n* No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;\n* According to RECIST 1.1, patients have at least one tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline have no radiotherapy or biopsy;\n* For premenopausal women with childbearing potential, a pregnancy test must be performed within 14 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;\n* Willing to use contraception (male patients); Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* small cell lung carcinoma;\n* History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP);\n* Confirmed EGFR Ex20ins or Ex19del or L858R or T790M mutant;\n* Patient who receive prior treatment including: any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI); the patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable; major surgery within 4 weeks of the first dose of investigational product (IP); radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP; CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to receive these drugs during the study period; traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive these drugs during the study period; patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period; the time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer.\n* Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapy before 6 months prior to the first dose IP;\n* At the beginning of study treatment, any unresolved toxic reaction to prior treatment is present, which exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinum treatment-related neuropathy;\n* Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids.\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of IP;\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, and active infection, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial;\n* Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease;\n* Any evidence of corneal injury;\n* Inadequate bone marrow reserve or organ function;\n* QT prolongation or any clinically important abnormalities in rhythm and heart function;\n* Pregnancy or lactation;\n* Patients who may have poor compliance with the research procedures and requirements, etc., as judged by investigators.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Provide informed consent prior to any study specific procedures;",
            "criterions": [
                {
                    "exact_snippets": "Provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 -70 years of age;",
            "criterions": [
                {
                    "exact_snippets": "18 -70 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks, life expectancy ≥12 weeks;",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS of 0 to 1 at screening",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no clinically significant deterioration in the previous 2 weeks",
                    "criterion": "clinically significant deterioration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy ≥12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathologically confirmed Non-Small Cell Lung Cancer (NSCLC);",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed Non-Small Cell Lung Cancer (NSCLC)",
                    "criterion": "Non-Small Cell Lung Cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy (stage IIIB-IV, according to the 8th edition of the AJCC staging system);",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced or metastatic NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to curative surgery or radiotherapy",
                    "criterion": "treatment amenability",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IIIB-IV, according to the 8th edition of the AJCC staging system",
                    "criterion": "AJCC staging system",
                    "requirements": [
                        {
                            "requirement_type": "edition",
                            "expected_value": "8th"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3.5,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with EGFR G719X or S768I or L861Q mutation diagnosed histologically or cytologically, the reports must be issued or recognized by Tier 3A hospitals. The mutations above may exist alone or together;",
            "criterions": [
                {
                    "exact_snippets": "EGFR G719X or S768I or L861Q mutation",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "G719X",
                                "S768I",
                                "L861Q"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed histologically or cytologically",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "reports must be issued or recognized by Tier 3A hospitals",
                    "criterion": "report recognition",
                    "requirements": [
                        {
                            "requirement_type": "recognition",
                            "expected_value": "Tier 3A hospitals"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;",
            "criterions": [
                {
                    "exact_snippets": "No previous systemic anti-tumor therapy",
                    "criterion": "previous systemic anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* According to RECIST 1.1, patients have at least one tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline have no radiotherapy or biopsy;",
            "criterions": [
                {
                    "exact_snippets": "at least one tumor lesion",
                    "criterion": "tumor lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "accurately and repeatably measurable at baseline",
                    "criterion": "tumor lesion measurement",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "accurately and repeatably measurable at baseline"
                        }
                    ]
                },
                {
                    "exact_snippets": "have no radiotherapy or biopsy",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": [
                                "no radiotherapy",
                                "no biopsy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For premenopausal women with childbearing potential, a pregnancy test must be performed within 14 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;",
            "criterions": [
                {
                    "exact_snippets": "premenopausal women with childbearing potential",
                    "criterion": "premenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "premenopausal women with childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a pregnancy test must be performed within 14 days before the first dose",
                    "criterion": "pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "the pregnancy test (blood or urine test) must be negative",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "female subjects must not be lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to use contraception (male patients); Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment.",
            "criterions": [
                {
                    "exact_snippets": "Willing to use contraception (male patients)",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Voluntary and agree to follow the study treatment protocol",
                    "criterion": "study treatment protocol adherence",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "follow-up plan",
                    "criterion": "follow-up plan adherence",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "can accept the oral medicine treatment",
                    "criterion": "oral medicine treatment acceptance",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* small cell lung carcinoma;",
            "criterions": [
                {
                    "exact_snippets": "small cell lung carcinoma",
                    "criterion": "small cell lung carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP);",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to active or inactive excipients of investigational product (IP)",
                    "criterion": "hypersensitivity to excipients of investigational product",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hypersensitivity to ... drugs with a similar chemical structure or class to investigational product (IP)",
                    "criterion": "hypersensitivity to drugs with similar chemical structure or class to investigational product",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Confirmed EGFR Ex20ins or Ex19del or L858R or T790M mutant;",
            "criterions": [
                {
                    "exact_snippets": "Confirmed EGFR Ex20ins",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "mutation type",
                            "expected_value": "Ex20ins"
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed EGFR ... Ex19del",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "mutation type",
                            "expected_value": "Ex19del"
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed EGFR ... L858R",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "mutation type",
                            "expected_value": "L858R"
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed EGFR ... T790M",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "mutation type",
                            "expected_value": "T790M"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who receive prior treatment including: any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI); the patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable; major surgery within 4 weeks of the first dose of investigational product (IP); radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP; CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to receive these drugs during the study period; traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive these drugs during the study period; patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period; the time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer.",
            "criterions": [
                {
                    "exact_snippets": "prior treatment including: any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI)",
                    "criterion": "prior treatment with EGFR-TKI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable",
                    "criterion": "intrapleural perfusion therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "major surgery within 4 weeks of the first dose of investigational product (IP)",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP",
                    "criterion": "radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "extent of treatment",
                            "expected_value": "> 30% of the bone marrow or wide field"
                        },
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose",
                    "criterion": "CYP3A4 strong inhibitor or strong inducer use",
                    "requirements": [
                        {
                            "requirement_type": "time since use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose",
                    "criterion": "traditional Chinese medicine with anti-tumor indications",
                    "requirements": [
                        {
                            "requirement_type": "time since use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period",
                    "criterion": "drugs known to prolong QTc interval or cause torsade de pointe",
                    "requirements": [
                        {
                            "requirement_type": "use during study",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "the time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer",
                    "criterion": "treatment with other investigational product or its analogue",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": "does not exceed 5 half-lives or 14 days, whichever is longer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapy before 6 months prior to the first dose IP;",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug",
                    "criterion": "prior systemic anti-cancer therapy for advanced NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except neoadjuvant or adjuvant therapy before 6 months prior to the first dose IP",
                    "criterion": "neoadjuvant or adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": -6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At the beginning of study treatment, any unresolved toxic reaction to prior treatment is present, which exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinum treatment-related neuropathy;",
            "criterions": [
                {
                    "exact_snippets": "unresolved toxic reaction to prior treatment is present",
                    "criterion": "unresolved toxic reaction to prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE)",
                    "criterion": "toxicity grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "exceeds Grade 2 for prior platinum treatment-related neuropathy",
                    "criterion": "platinum treatment-related neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids.",
            "criterions": [
                {
                    "exact_snippets": "Spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic and unstable brain metastases",
                    "criterion": "symptomatic and unstable brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "completed definitive therapy",
                    "criterion": "definitive therapy completion",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not on steroids",
                    "criterion": "steroid use",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids",
                    "criterion": "neurological status",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of IP;",
            "criterions": [
                {
                    "exact_snippets": "Refractory nausea and vomiting",
                    "criterion": "nausea and vomiting",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic gastrointestinal diseases",
                    "criterion": "gastrointestinal diseases",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "chronic"
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to swallow the formulated product",
                    "criterion": "ability to swallow formulated product",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous significant bowel resection that would preclude adequate absorption of IP",
                    "criterion": "bowel resection",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "impact on absorption",
                            "expected_value": "preclude adequate absorption of IP"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, and active infection, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial;",
            "criterions": [
                {
                    "exact_snippets": "severe or uncontrolled systemic diseases",
                    "criterion": "systemic diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active bleeding diatheses",
                    "criterion": "bleeding diatheses",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease;",
            "criterions": [
                {
                    "exact_snippets": "Past medical history of Interstitial Lung Disease (ILD)",
                    "criterion": "past medical history of Interstitial Lung Disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "drug-induced Interstitial Lung Disease",
                    "criterion": "drug-induced Interstitial Lung Disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation pneumonitis that required steroid treatment",
                    "criterion": "radiation pneumonitis requiring steroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any evidence of clinically active Interstitial Lung Disease",
                    "criterion": "clinically active Interstitial Lung Disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any evidence of corneal injury;",
            "criterions": [
                {
                    "exact_snippets": "evidence of corneal injury",
                    "criterion": "corneal injury",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate bone marrow reserve or organ function;",
            "criterions": [
                {
                    "exact_snippets": "Inadequate bone marrow reserve",
                    "criterion": "bone marrow reserve",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate ... organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* QT prolongation or any clinically important abnormalities in rhythm and heart function;",
            "criterions": [
                {
                    "exact_snippets": "QT prolongation",
                    "criterion": "QT prolongation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically important abnormalities in rhythm",
                    "criterion": "abnormalities in heart rhythm",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically important"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically important abnormalities in ... heart function",
                    "criterion": "abnormalities in heart function",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically important"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or lactation;",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who may have poor compliance with the research procedures and requirements, etc., as judged by investigators.",
            "criterions": [
                {
                    "exact_snippets": "Patients who may have poor compliance with the research procedures and requirements, etc., as judged by investigators.",
                    "criterion": "compliance with research procedures and requirements",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "as judged by investigators"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}