{
    "info": {
        "nct_id": "NCT04054531",
        "official_title": "An Open-label, Phase II Study of KN046 Evaluating the Efficacy and Safety of KN046 Plus Platinum-based Doublet Chemotherapy as First Line Therapy in Advanced Non-small Cell Lung Cancer Subjects.",
        "inclusion_criteria": "* Has a histologically or cytologically confirmed diagnosis of stage IV NSCLC;\n* Has not received prior systemic treatment for metastatic NSCLC;\n* Has measurable disease based on RECIST 1.1.\n* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.\n* Has adequate organ function.\n* Has provided tumor tissue from locations not radiated prior to biopsy.\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)\n* Previously untreated or symptomatic central nervous system (CNS) metastases\n* Has received a live-virus vaccination within 28 days of planned treatment start.\n* Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody and chemotherapy.\n* Has or had active autoimmune disease.",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "* Has a histologically or cytologically confirmed diagnosis of stage IV NSCLC;",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed diagnosis of stage IV NSCLC",
                    "criterion": "NSCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has not received prior systemic treatment for metastatic NSCLC;",
            "criterions": [
                {
                    "exact_snippets": "Has not received prior systemic treatment",
                    "criterion": "prior systemic treatment for metastatic NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has measurable disease based on RECIST 1.1.",
            "criterions": [
                {
                    "exact_snippets": "Has measurable disease based on RECIST 1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.",
            "criterions": [
                {
                    "exact_snippets": "performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has adequate organ function.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has provided tumor tissue from locations not radiated prior to biopsy.",
            "criterions": [
                {
                    "exact_snippets": "provided tumor tissue",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locations not radiated prior to biopsy",
                    "criterion": "tumor tissue location",
                    "requirements": [
                        {
                            "requirement_type": "radiation status",
                            "expected_value": "not radiated prior to biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Key",
                    "criterion": "key",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)",
            "criterions": [
                {
                    "exact_snippets": "Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)",
                    "criterion": "previous immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously untreated or symptomatic central nervous system (CNS) metastases",
            "criterions": [
                {
                    "exact_snippets": "Previously untreated ... central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received a live-virus vaccination within 28 days of planned treatment start.",
            "criterions": [
                {
                    "exact_snippets": "Has received a live-virus vaccination within 28 days of planned treatment start.",
                    "criterion": "live-virus vaccination",
                    "requirements": [
                        {
                            "requirement_type": "time since vaccination",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody and chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody",
                    "criterion": "hypersensitivity reaction to monoclonal antibody",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "temporal",
                            "expected_value": "previously"
                        }
                    ]
                },
                {
                    "exact_snippets": "Previously had a severe hypersensitivity reaction to treatment with ... chemotherapy",
                    "criterion": "hypersensitivity reaction to chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "temporal",
                            "expected_value": "previously"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has or had active autoimmune disease.",
            "criterions": [
                {
                    "exact_snippets": "Has or had active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Key",
                    "criterion": "key",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}