{
    "info": {
        "nct_id": "NCT06734182",
        "official_title": "A Prospective, Single-arm, Multicenter, Phase II Clinical Study on Envafolimab Combined With Disitamab Vedotin And Carboplatin for Resectable, Stage II-III, HER2-Mutant Non-Small Cell Lung Cancer",
        "inclusion_criteria": "1. Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);\n2. Aged 18-75 years, male or female;\n3. Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; N2 should be confirmed by mediastinoscopy or EBUS.\n4. PET-CT or CT plus MRI should be completed before enrollment;\n5. HER2 mutations identified by histological specimens;\n6. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1 (RECIST v1.1);\n7. Tumor tissue specimens and blood sample available for detection of MRD and biomarkers (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment);\n8. ECOG score 0-1;\n9. No contraindications to immunotherapy;\n10. Adequate organ function:\n11. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;\n12. Pulmonary function being able to withstand the planned surgery evaluated by surgeons;\n13. Women of childbearing potential must undergo a serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female patients of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Presence of locally advanced, unresectable or metastatic disease; unresectable includes the unresectable defined in the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019), including partial stage IIIA and IIIB and all the stage IIIC;\n2. Participants with known EGFR sensitive mutations or ALK translocation, KRAS sensitive mutations, BRAF V600E, ROS1 fusions, RET fusions, MET exon 14 alterations and MET amplification, NTRK fusions;\n3. Previous treatment with systemic antitumor therapy for early NSCLC, including investigational product;\n4. History of (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment, or ongoing pneumonitis/interstitial lung disease requiring steroid treatment;\n5. Active tuberculosis;\n6. Active infection requiring systemic treatment;\n7. Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;\n8. Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); (the subjects with HBV-DNA assay <500 IU/mL within 28 days prior to randomization who have received local standard antiviral therapy for at least 14 days and are willing to receive antiviral therapy continuously during the study can be enrolled); active hepatitis C (defined as positive hepatitis C surface antibody [HCsAb] in screening period and positive HCV-RNA);\n9. Known human immunodeficiency virus (HIV) infection (known positive HIV antibody);\n10. Vaccination of live vaccine within 30 days prior to the first dose. Including but not limited to the following: parotitis, rubella, measles, varicella/ herpes zoster (varicella), yellow fever, Rabies, Bacille Calmette-Guérin (BCG) and typhoid vaccine (inactivated virus vaccine allowed);\n11. Previous use of PD-1/PD-L1 agent or the drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40);\n12. Severe allergic reaction to other monoclonal antibodies;\n13. Known serious or uncontrolled pre-existing diseases; including but not limited to cardiovascular events with hemodynamic instability, symptomatic cerebrovascular events, and hepatic cirrhosis above Child-Pugh A within 6 months;\n14. Other malignant tumors within 5 years prior to the first dose, except non-small cell lung cancer. The malignant tumors with negligible risk of metastasis or death (e.g., expected disease-free survival > 5 years) and expected to achieve radical outcomes after treatment (e.g., sufficiently treated carcinoma in situ of cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated for radical surgery) can be excluded",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);",
            "criterions": [
                {
                    "exact_snippets": "sufficient understanding of this study",
                    "criterion": "understanding of study",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to sign the informed consent form (ICF)",
                    "criterion": "willingness to sign informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Aged 18-75 years, male or female;",
            "criterions": [
                {
                    "exact_snippets": "Aged 18-75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; N2 should be confirmed by mediastinoscopy or EBUS.",
            "criterions": [
                {
                    "exact_snippets": "Treatment-naive",
                    "criterion": "treatment status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "naive"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "resectable",
                    "criterion": "resectability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "IIIA",
                                "IIIB"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cTNM stage can be confirmed through PET-CT or pathological biopsy",
                    "criterion": "cTNM stage confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "PET-CT",
                                "pathological biopsy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "N2 should be confirmed by mediastinoscopy or EBUS",
                    "criterion": "N2 confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "mediastinoscopy",
                                "EBUS"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. PET-CT or CT plus MRI should be completed before enrollment;",
            "criterions": [
                {
                    "exact_snippets": "PET-CT or CT plus MRI should be completed before enrollment",
                    "criterion": "PET-CT",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PET-CT or CT plus MRI should be completed before enrollment",
                    "criterion": "CT plus MRI",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. HER2 mutations identified by histological specimens;",
            "criterions": [
                {
                    "exact_snippets": "HER2 mutations identified by histological specimens",
                    "criterion": "HER2 mutations",
                    "requirements": [
                        {
                            "requirement_type": "identification method",
                            "expected_value": "histological specimens"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1 (RECIST v1.1);",
            "criterions": [
                {
                    "exact_snippets": "Measurable lesions based on the response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "based on RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Tumor tissue specimens and blood sample available for detection of MRD and biomarkers (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment);",
            "criterions": [
                {
                    "exact_snippets": "Tumor tissue specimens ... available",
                    "criterion": "tumor tissue specimens",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "blood sample available",
                    "criterion": "blood sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment",
                    "criterion": "tumor tissue specimens",
                    "requirements": [
                        {
                            "requirement_type": "freshness",
                            "expected_value": "freshly obtained or archived samples within 3 months prior to enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. ECOG score 0-1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG score 0-1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. No contraindications to immunotherapy;",
            "criterions": [
                {
                    "exact_snippets": "No contraindications to immunotherapy",
                    "criterion": "contraindications to immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Adequate organ function:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;",
            "criterions": [
                {
                    "exact_snippets": "Being willing and able to comply with the visits",
                    "criterion": "compliance with study visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Being willing and able to comply with the ... treatment plan",
                    "criterion": "compliance with treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Being willing and able to comply with the ... laboratory examinations",
                    "criterion": "compliance with laboratory examinations",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Being willing and able to comply with the ... other study procedures",
                    "criterion": "compliance with other study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Pulmonary function being able to withstand the planned surgery evaluated by surgeons;",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary function being able to withstand the planned surgery",
                    "criterion": "pulmonary function",
                    "requirements": [
                        {
                            "requirement_type": "ability to withstand surgery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Women of childbearing potential must undergo a serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female patients of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential must undergo a serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the result must be negative",
                    "criterion": "serum pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods",
                    "criterion": "use of highly effective contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study period and within 180 days after the last dose of study drug",
                    "criterion": "duration of contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study period and within 180 days after the last dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Presence of locally advanced, unresectable or metastatic disease; unresectable includes the unresectable defined in the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019), including partial stage IIIA and IIIB and all the stage IIIC;",
            "criterions": [
                {
                    "exact_snippets": "Presence of locally advanced, unresectable or metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable includes the unresectable defined in the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019), including partial stage IIIA and IIIB and all the stage IIIC",
                    "criterion": "unresectability",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Participants with known EGFR sensitive mutations or ALK translocation, KRAS sensitive mutations, BRAF V600E, ROS1 fusions, RET fusions, MET exon 14 alterations and MET amplification, NTRK fusions;",
            "criterions": [
                {
                    "exact_snippets": "EGFR sensitive mutations",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": "sensitive"
                        }
                    ]
                },
                {
                    "exact_snippets": "ALK translocation",
                    "criterion": "ALK translocation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "KRAS sensitive mutations",
                    "criterion": "KRAS mutation",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": "sensitive"
                        }
                    ]
                },
                {
                    "exact_snippets": "BRAF V600E",
                    "criterion": "BRAF mutation",
                    "requirements": [
                        {
                            "requirement_type": "specific mutation",
                            "expected_value": "V600E"
                        }
                    ]
                },
                {
                    "exact_snippets": "ROS1 fusions",
                    "criterion": "ROS1 fusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "RET fusions",
                    "criterion": "RET fusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MET exon 14 alterations",
                    "criterion": "MET exon 14 alteration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MET amplification",
                    "criterion": "MET amplification",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "NTRK fusions",
                    "criterion": "NTRK fusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Previous treatment with systemic antitumor therapy for early NSCLC, including investigational product;",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with systemic antitumor therapy",
                    "criterion": "previous systemic antitumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for early NSCLC",
                    "criterion": "early NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including investigational product",
                    "criterion": "investigational product",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment, or ongoing pneumonitis/interstitial lung disease requiring steroid treatment;",
            "criterions": [
                {
                    "exact_snippets": "History of (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment",
                    "criterion": "history of pneumonitis/interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroid"
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing pneumonitis/interstitial lung disease requiring steroid treatment",
                    "criterion": "ongoing pneumonitis/interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroid"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Active tuberculosis;",
            "criterions": [
                {
                    "exact_snippets": "Active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Active infection requiring systemic treatment;",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic treatment",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "systemic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;",
            "criterions": [
                {
                    "exact_snippets": "any known or suspected autoimmune disorder",
                    "criterion": "autoimmune disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose",
                    "criterion": "hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "hormone therapy is not needed or well controlled at physiological dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "controlled type I diabetes",
                    "criterion": "type I diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); (the subjects with HBV-DNA assay <500 IU/mL within 28 days prior to randomization who have received local standard antiviral therapy for at least 14 days and are willing to receive antiviral therapy continuously during the study can be enrolled); active hepatitis C (defined as positive hepatitis C surface antibody [HCsAb] in screening period and positive HCV-RNA);",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] in screening period with HBV-DNA detected higher than the upper limit of normal",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "HBsAg presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "HBV-DNA level",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C (defined as positive hepatitis C surface antibody [HCsAb] in screening period and positive HCV-RNA)",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "HCsAb presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "HCV-RNA presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Known human immunodeficiency virus (HIV) infection (known positive HIV antibody);",
            "criterions": [
                {
                    "exact_snippets": "Known human immunodeficiency virus (HIV) infection (known positive HIV antibody)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Vaccination of live vaccine within 30 days prior to the first dose. Including but not limited to the following: parotitis, rubella, measles, varicella/ herpes zoster (varicella), yellow fever, Rabies, Bacille Calmette-Guérin (BCG) and typhoid vaccine (inactivated virus vaccine allowed);",
            "criterions": [
                {
                    "exact_snippets": "Vaccination of live vaccine within 30 days prior to the first dose",
                    "criterion": "live vaccine vaccination",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "parotitis",
                    "criterion": "parotitis vaccination",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "rubella",
                    "criterion": "rubella vaccination",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "measles",
                    "criterion": "measles vaccination",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "varicella/ herpes zoster (varicella)",
                    "criterion": "varicella/herpes zoster vaccination",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "yellow fever",
                    "criterion": "yellow fever vaccination",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Rabies",
                    "criterion": "rabies vaccination",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Bacille Calmette-Guérin (BCG)",
                    "criterion": "BCG vaccination",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "typhoid vaccine (inactivated virus vaccine allowed)",
                    "criterion": "typhoid vaccination",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Previous use of PD-1/PD-L1 agent or the drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40);",
            "criterions": [
                {
                    "exact_snippets": "Previous use of PD-1/PD-L1 agent",
                    "criterion": "previous use of PD-1/PD-L1 agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40)",
                    "criterion": "previous use of drug acting on another targeted T cell receptor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Severe allergic reaction to other monoclonal antibodies;",
            "criterions": [
                {
                    "exact_snippets": "Severe allergic reaction to other monoclonal antibodies",
                    "criterion": "allergic reaction to monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Known serious or uncontrolled pre-existing diseases; including but not limited to cardiovascular events with hemodynamic instability, symptomatic cerebrovascular events, and hepatic cirrhosis above Child-Pugh A within 6 months;",
            "criterions": [
                {
                    "exact_snippets": "serious or uncontrolled pre-existing diseases",
                    "criterion": "pre-existing diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious or uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiovascular events with hemodynamic instability",
                    "criterion": "cardiovascular events",
                    "requirements": [
                        {
                            "requirement_type": "hemodynamic stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic cerebrovascular events",
                    "criterion": "cerebrovascular events",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "present"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatic cirrhosis above Child-Pugh A within 6 months",
                    "criterion": "hepatic cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "above Child-Pugh A"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Other malignant tumors within 5 years prior to the first dose, except non-small cell lung cancer. The malignant tumors with negligible risk of metastasis or death (e.g., expected disease-free survival > 5 years) and expected to achieve radical outcomes after treatment (e.g., sufficiently treated carcinoma in situ of cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated for radical surgery) can be excluded",
            "criterions": [
                {
                    "exact_snippets": "Other malignant tumors within 5 years prior to the first dose",
                    "criterion": "other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malignant tumors with negligible risk of metastasis or death",
                    "criterion": "malignant tumors with negligible risk of metastasis or death",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "negligible"
                        }
                    ]
                },
                {
                    "exact_snippets": "expected disease-free survival > 5 years",
                    "criterion": "disease-free survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "expected to achieve radical outcomes after treatment",
                    "criterion": "radical outcomes after treatment",
                    "requirements": [
                        {
                            "requirement_type": "expectation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficiently treated carcinoma in situ of cervix",
                    "criterion": "carcinoma in situ of cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "basal or squamous cell skin cancer",
                    "criterion": "basal or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal carcinoma in situ treated for radical surgery",
                    "criterion": "ductal carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "radical surgery"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}