{
    "info": {
        "nct_id": "NCT06813365",
        "official_title": "A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutation (TIAN-SHAN2)",
        "inclusion_criteria": "1. Patients must be able to provide documented informed consent.\n2. Aged ≥ 18 years.\n3. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy.\n4. Documentation of EGFR mutation from a local CLIA-certified laboratory (or equivalent). Part A: EGFR sensitizing mutation (Exon19del and/or L858R). Part B: EGFR sensitizing mutation (Exon19del and/or L858R) and C797X mutation.\n5. Provide adequate amount of pretreatment tumor samples collected after disease progression on the last EGFR TKI treatment.\n6. Failed (progressed or are intolerant) at least 1 prior EGFR TKI regimen. Patients enrolled in Part A will be required to have progressed or become intolerant after adequate treatment with at least one-line EGFR TKI and platinum-containing chemotherapy.\n7. ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.\n8. Patients with brain metastases must have a stable BM status.\n9. Measurable disease per RECIST 1.1.\n10. Adequate hematopoietic and other organ system functions.\n11. Male Patients with female partners of childbearing potential should use barrier contraceptives and refrain from donating sperm during their participation in this study and for 3 months following the last dose of the study drug.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.)(Part B).\n2. NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.\n3. Prior treatment with any of the following:1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration;2)Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a previous treatment regimen or clinical study within 14 days prior to the first administration;3)Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days before screening;4)Currently receiving or unable to stop drug or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP)3A4. A washout period of at least 2 weeks for strong inhibitors and 3 weeks for strong inducers is required prior to the first study drug administration.5)currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 14 days is required prior to the first study drug administration;6)currently receiving or unable to stop drugs known to be proton pump inhibitors. A washout period of at least 7 days is required prior to the first study drug administration;7)Major surgery within 4 weeks of the first administration of DZD6008 or anticipated during the study period.\n4. Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.\n5. Spinal cord compression or leptomeningeal metastasis.\n6. Patients with any other malignancy within 2 years of the first administration of study drug.\n7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by investigator.\n8. Patients with active infection including but not limited to HBV, HCV, HIV and active infection of COVID-19.\n9. Resting QTcF > 470 msec; Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG;Any factors that increase the risk of QTc prolongation.\n10. Past medical history of ILD or active ILD.\n11. Diseases which would preclude adequate absorption of DZD6008.\n12. Received a live vaccine within 2 weeks before the first administration of DZD6008.\n13. Women who are pregnant or breastfeeding.\n14. Hypersensitivity to active or inactive excipients of DZD6008.\n15. Involvement in the planning and conduct of the study.\n16. Judgment by the investigator that the patients is unlikely to comply with study procedures",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients must be able to provide documented informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to provide documented informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability to provide",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Aged ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Aged ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed diagnosis of NSCLC",
                    "criterion": "NSCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not suitable for curative therapy",
                    "criterion": "suitability for curative therapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Documentation of EGFR mutation from a local CLIA-certified laboratory (or equivalent). Part A: EGFR sensitizing mutation (Exon19del and/or L858R). Part B: EGFR sensitizing mutation (Exon19del and/or L858R) and C797X mutation.",
            "criterions": [
                {
                    "exact_snippets": "Documentation of EGFR mutation from a local CLIA-certified laboratory (or equivalent).",
                    "criterion": "EGFR mutation documentation",
                    "requirements": [
                        {
                            "requirement_type": "source",
                            "expected_value": "local CLIA-certified laboratory (or equivalent)"
                        }
                    ]
                },
                {
                    "exact_snippets": "Part A: EGFR sensitizing mutation (Exon19del and/or L858R).",
                    "criterion": "EGFR sensitizing mutation",
                    "requirements": [
                        {
                            "requirement_type": "mutation type",
                            "expected_value": [
                                "Exon19del",
                                "L858R"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Part B: EGFR sensitizing mutation (Exon19del and/or L858R) and C797X mutation.",
                    "criterion": "EGFR sensitizing mutation",
                    "requirements": [
                        {
                            "requirement_type": "mutation type",
                            "expected_value": [
                                "Exon19del",
                                "L858R"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Part B: ... C797X mutation.",
                    "criterion": "C797X mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Provide adequate amount of pretreatment tumor samples collected after disease progression on the last EGFR TKI treatment.",
            "criterions": [
                {
                    "exact_snippets": "adequate amount of pretreatment tumor samples",
                    "criterion": "pretreatment tumor samples",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "collected after disease progression on the last EGFR TKI treatment",
                    "criterion": "collection timing of tumor samples",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after disease progression on the last EGFR TKI treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Failed (progressed or are intolerant) at least 1 prior EGFR TKI regimen. Patients enrolled in Part A will be required to have progressed or become intolerant after adequate treatment with at least one-line EGFR TKI and platinum-containing chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Failed (progressed or are intolerant) at least 1 prior EGFR TKI regimen",
                    "criterion": "prior EGFR TKI regimen",
                    "requirements": [
                        {
                            "requirement_type": "failure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients enrolled in Part A will be required to have progressed or become intolerant after adequate treatment with at least one-line EGFR TKI",
                    "criterion": "EGFR TKI treatment",
                    "requirements": [
                        {
                            "requirement_type": "progression or intolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients enrolled in Part A will be required to have progressed or become intolerant after adequate treatment with ... platinum-containing chemotherapy",
                    "criterion": "platinum-containing chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "progression or intolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "predicted life expectancy ≥ 12 weeks",
                    "criterion": "predicted life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with brain metastases must have a stable BM status.",
            "criterions": [
                {
                    "exact_snippets": "Patients with brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a stable BM status",
                    "criterion": "brain metastases status",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Measurable disease per RECIST 1.1.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease per RECIST 1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Adequate hematopoietic and other organ system functions.",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematopoietic ... functions.",
                    "criterion": "hematopoietic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... other organ system functions.",
                    "criterion": "other organ system functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Male Patients with female partners of childbearing potential should use barrier contraceptives and refrain from donating sperm during their participation in this study and for 3 months following the last dose of the study drug.",
            "criterions": [
                {
                    "exact_snippets": "Male Patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "female partners of childbearing potential",
                    "criterion": "partner's childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "should use barrier contraceptives",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "barrier"
                        }
                    ]
                },
                {
                    "exact_snippets": "refrain from donating sperm",
                    "criterion": "sperm donation",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "during their participation in this study and for 3 months following the last dose of the study drug",
                    "criterion": "timeframe for contraceptive use and sperm donation restriction",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during study and 3 months after last dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.)(Part B).",
            "criterions": [
                {
                    "exact_snippets": "Carry any other known EGFR alterations",
                    "criterion": "EGFR alterations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.)",
                    "criterion": "uncommon EGFR mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "G719X",
                                "S768I",
                                "L861Q",
                                "exon 20 insertions"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.",
            "criterions": [
                {
                    "exact_snippets": "NSCLC with mixed small cell lung cancer (SCLC)",
                    "criterion": "NSCLC with mixed SCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC with histologic SCLC transformation",
                    "criterion": "NSCLC with histologic SCLC transformation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.",
            "criterions": [
                {
                    "exact_snippets": "unresolved toxicities from prior anti-cancer therapy",
                    "criterion": "unresolved toxicities from prior anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Spinal cord compression or leptomeningeal metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal metastasis",
                    "criterion": "leptomeningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with any other malignancy within 2 years of the first administration of study drug.",
            "criterions": [
                {
                    "exact_snippets": "any other malignancy within 2 years of the first administration of study drug",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by investigator.",
            "criterions": [
                {
                    "exact_snippets": "evidence of severe or uncontrolled systemic diseases",
                    "criterion": "systemic diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe or uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "active bleeding diatheses",
                    "criterion": "bleeding diatheses",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with active infection including but not limited to HBV, HCV, HIV and active infection of COVID-19.",
            "criterions": [
                {
                    "exact_snippets": "active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV",
                    "criterion": "HBV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV",
                    "criterion": "HCV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection of COVID-19",
                    "criterion": "COVID-19 infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Resting QTcF > 470 msec; Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG;Any factors that increase the risk of QTc prolongation.",
            "criterions": [
                {
                    "exact_snippets": "Resting QTcF > 470 msec",
                    "criterion": "Resting QTcF",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant abnormalities in rhythm, conduction or morphology of resting ECG",
                    "criterion": "abnormalities in rhythm, conduction or morphology of resting ECG",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "factors that increase the risk of QTc prolongation",
                    "criterion": "risk of QTc prolongation",
                    "requirements": [
                        {
                            "requirement_type": "risk factors",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Past medical history of ILD or active ILD.",
            "criterions": [
                {
                    "exact_snippets": "Past medical history of ILD",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active ILD",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Diseases which would preclude adequate absorption of DZD6008.",
            "criterions": [
                {
                    "exact_snippets": "Diseases which would preclude adequate absorption of DZD6008.",
                    "criterion": "diseases affecting absorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Received a live vaccine within 2 weeks before the first administration of DZD6008.",
            "criterions": [
                {
                    "exact_snippets": "Received a live vaccine within 2 weeks before the first administration of DZD6008.",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Women who are pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Hypersensitivity to active or inactive excipients of DZD6008.",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to active or inactive excipients of DZD6008",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Involvement in the planning and conduct of the study.",
            "criterions": [
                {
                    "exact_snippets": "Involvement in the planning and conduct of the study.",
                    "criterion": "involvement in study planning and conduct",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Judgment by the investigator that the patients is unlikely to comply with study procedures",
            "criterions": [
                {
                    "exact_snippets": "Judgment by the investigator that the patients is unlikely to comply with study procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "unlikely"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "3. Prior treatment with any of the following:1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration;2)Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a previous treatment regimen or clinical study within 14 days prior to the first administration;3)Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days before screening;4)Currently receiving or unable to stop drug or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP)3A4. A washout period of at least 2 weeks for strong inhibitors and 3 weeks for strong inducers is required prior to the first study drug administration.5)currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 14 days is required prior to the first study drug administration;6)currently receiving or unable to stop drugs known to be proton pump inhibitors. A washout period of at least 7 days is required prior to the first study drug administration;7)Major surgery within 4 weeks of the first administration of DZD6008 or anticipated during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with any of the following: Immunotherapy or other antibody therapy within 4 weeks prior to the first administration",
                    "criterion": "prior immunotherapy or antibody therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with any of the following: Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a previous treatment regimen or clinical study within 14 days prior to the first administration",
                    "criterion": "prior cytotoxic chemotherapy, investigational drugs or other anticancer drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with any of the following: Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose",
                    "criterion": "prior radiotherapy with a limited field of radiation for palliation",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with any of the following: radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days before screening",
                    "criterion": "prior radiation to more than 30% of the bone marrow or with a wide field of radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently receiving or unable to stop drug or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP)3A4",
                    "criterion": "use of potent inhibitors or inducers of CYP3A4",
                    "requirements": [
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index",
                    "criterion": "use of CYP3A4 sensitive substrate with a narrow therapeutic index",
                    "requirements": [
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently receiving or unable to stop drugs known to be proton pump inhibitors",
                    "criterion": "use of proton pump inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Major surgery within 4 weeks of the first administration of DZD6008 or anticipated during the study period",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}