{
    "info": {
        "nct_id": "NCT06323148",
        "official_title": "Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA",
        "inclusion_criteria": "1. Age greater than 18 years old, both males and females are eligible.\n2. Histologically confirmed diagnosis of non-small cell lung cancer.\n3. Diagnosis of stage II-IIIA (N1-N2) non-small cell lung cancer based on the 8th edition TNM staging guidelines combined with radiological evaluation.\n4. EGFR mutation-positive status confirmed through molecular testing (such as ARMS-PCR or high-throughput sequencing), specifically with mutations 19del or 21L858R.\n5. Able to undergo R0 surgical resection.\n6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1. Expected survival of more than 12 months.\n7. Baseline blood routine and biochemical indicators meeting the following criteria:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;\n   * Lymphocyte count ≥ 0.5 × 10^9/L;\n   * Platelet count ≥ 100 × 10^9/L;\n   * Hemoglobin ≥ 9 g/dL.\n   * Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 times ULN.\n8. Patients must provide informed consent, either directly or through their legally authorized representatives, after being informed about the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Pathological diagnosis of mixed-type lung cancer (including a history of small cell lung cancer or non-adenocarcinoma).\n2. Received anti-tumor therapy before surgery (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).\n3. Rx, R1, R2 surgical resection.\n4. Received blood transfusion during surgery or within 2 weeks before surgery.\n5. Pregnant or lactating female patients.\n6. History of other malignant tumors within the past 5 years, except for cases where other malignant tumors have been cured solely through surgery with a disease-free interval of at least 10 years, curable basal cell carcinoma of the skin, and cervical carcinoma in situ.\n7. Any unstable systemic diseases (including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within the past year, severe arrhythmias requiring medication, liver, kidney, or metabolic diseases).\n8. Evidence of any other diseases, neurological or metabolic functional disorders, physical examination findings, or laboratory findings that would place the subject at high risk of treatment-related complications.\n9. Other factors deemed by the investigators to potentially affect the study process.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age greater than 18 years old, both males and females are eligible.",
            "criterions": [
                {
                    "exact_snippets": "Age greater than 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "both males and females are eligible",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically confirmed diagnosis of non-small cell lung cancer.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Diagnosis of stage II-IIIA (N1-N2) non-small cell lung cancer based on the 8th edition TNM staging guidelines combined with radiological evaluation.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of stage II-IIIA (N1-N2) non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "IIIA"
                            ]
                        },
                        {
                            "requirement_type": "nodal involvement",
                            "expected_value": [
                                "N1",
                                "N2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "based on the 8th edition TNM staging guidelines",
                    "criterion": "TNM staging guidelines",
                    "requirements": [
                        {
                            "requirement_type": "edition",
                            "expected_value": "8th"
                        }
                    ]
                },
                {
                    "exact_snippets": "combined with radiological evaluation",
                    "criterion": "radiological evaluation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. EGFR mutation-positive status confirmed through molecular testing (such as ARMS-PCR or high-throughput sequencing), specifically with mutations 19del or 21L858R.",
            "criterions": [
                {
                    "exact_snippets": "EGFR mutation-positive status confirmed through molecular testing",
                    "criterion": "EGFR mutation-positive status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "ARMS-PCR",
                                "high-throughput sequencing"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "mutations 19del or 21L858R",
                    "criterion": "EGFR mutation type",
                    "requirements": [
                        {
                            "requirement_type": "specific mutations",
                            "expected_value": [
                                "19del",
                                "21L858R"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Able to undergo R0 surgical resection.",
            "criterions": [
                {
                    "exact_snippets": "Able to undergo R0 surgical resection.",
                    "criterion": "R0 surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1. Expected survival of more than 12 months.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1",
                    "criterion": "ECOG PS score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Expected survival of more than 12 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Baseline blood routine and biochemical indicators meeting the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Baseline blood routine and biochemical indicators",
                    "criterion": "blood routine and biochemical indicators",
                    "requirements": [
                        {
                            "requirement_type": "baseline",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lymphocyte count ≥ 0.5 × 10^9/L;",
            "criterions": [
                {
                    "exact_snippets": "Lymphocyte count ≥ 0.5 × 10^9/L",
                    "criterion": "lymphocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.5,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100 × 10^9/L;",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100 × 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9 g/dL.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the upper limit of normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 times ULN.",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ... ≤ 2.5 times ULN",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ... ≤ 2.5 times ULN",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase (ALP) ≤ 2.5 times ULN",
                    "criterion": "alkaline phosphatase (ALP)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients must provide informed consent, either directly or through their legally authorized representatives, after being informed about the study.",
            "criterions": [
                {
                    "exact_snippets": "Patients must provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "either directly or through their legally authorized representatives",
                    "criterion": "method of consent provision",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "directly",
                                "through legally authorized representatives"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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. Pathological diagnosis of mixed-type lung cancer (including a history of small cell lung cancer or non-adenocarcinoma).",
            "criterions": [
                {
                    "exact_snippets": "Pathological diagnosis of mixed-type lung cancer",
                    "criterion": "mixed-type lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of small cell lung cancer",
                    "criterion": "small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... non-adenocarcinoma",
                    "criterion": "non-adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Received anti-tumor therapy before surgery (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).",
            "criterions": [
                {
                    "exact_snippets": "Received anti-tumor therapy before surgery (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)",
                    "criterion": "anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "before surgery"
                        },
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "radiotherapy",
                                "chemotherapy",
                                "targeted therapy",
                                "immunotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Rx, R1, R2 surgical resection.",
            "criterions": [
                {
                    "exact_snippets": "Rx, R1, R2 surgical resection.",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "Rx",
                                "R1",
                                "R2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Received blood transfusion during surgery or within 2 weeks before surgery.",
            "criterions": [
                {
                    "exact_snippets": "Received blood transfusion during surgery",
                    "criterion": "blood transfusion during surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Received blood transfusion ... within 2 weeks before surgery",
                    "criterion": "blood transfusion within 2 weeks before surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Pregnant or lactating female patients.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of other malignant tumors within the past 5 years, except for cases where other malignant tumors have been cured solely through surgery with a disease-free interval of at least 10 years, curable basal cell carcinoma of the skin, and cervical carcinoma in situ.",
            "criterions": [
                {
                    "exact_snippets": "History of other malignant tumors within the past 5 years",
                    "criterion": "history of other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cases where other malignant tumors have been cured solely through surgery with a disease-free interval of at least 10 years",
                    "criterion": "cured malignant tumors through surgery",
                    "requirements": [
                        {
                            "requirement_type": "disease-free interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "curable basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "curability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical carcinoma in situ",
                    "criterion": "cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Any unstable systemic diseases (including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within the past year, severe arrhythmias requiring medication, liver, kidney, or metabolic diseases).",
            "criterions": [
                {
                    "exact_snippets": "unstable systemic diseases",
                    "criterion": "systemic diseases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active infections",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the past year",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "severe arrhythmias requiring medication",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "liver, kidney, or metabolic diseases",
                    "criterion": "liver, kidney, or metabolic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Evidence of any other diseases, neurological or metabolic functional disorders, physical examination findings, or laboratory findings that would place the subject at high risk of treatment-related complications.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of any other diseases",
                    "criterion": "other diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "neurological or metabolic functional disorders",
                    "criterion": "neurological or metabolic functional disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination findings",
                    "criterion": "physical examination findings",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory findings",
                    "criterion": "laboratory findings",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Other factors deemed by the investigators to potentially affect the study process.",
            "criterions": [
                {
                    "exact_snippets": "Other factors deemed by the investigators to potentially affect the study process.",
                    "criterion": "other factors",
                    "requirements": [
                        {
                            "requirement_type": "potential impact",
                            "expected_value": "affect the study process"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}