{
    "info": {
        "nct_id": "NCT04964960",
        "official_title": "Phase II Investigation of Use of CNS Active Pembrolizumab and Chemotherapy for Asymptomatic Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)",
        "inclusion_criteria": "* Non-small cell lunch cancer (NSLC) with untreated asymptomatic brain metastases\n* NSLC lacks oncogenic driver mutations\n* Absence of new onset neurological symptoms\n* Presence of fewer than ten intracranial lesions\n* Each lesion measures three centimeters or less\n* Life expectancy of greater than three months\n* Adequate organ and marrow function\n* Ability to understand and willingness to sign a written informed consent document\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "* Presence of oncogenic driver mutations\n* Measurable lesion located within 10mm of the optic chiasm or optic nerve, or within the brainstem\n* Known leptomeningeal involvement.\n* Midline shift\n* Serious non-healing wound, ulcer or bone fracture\n* Baseline inability to participate or complete neurocognitive testing\n* Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury within 14 days prior to registration\n* Receipt of a non-CNS minor surgical procedure (e.g. core biopsy or fine needle aspiration) within three days prior to registration\n* History of allergic reactions attributed to monoclonal antibodies (mAb), compounds of similar chemical or biologic composition to Pembrolizumab\n* Clinically significant cardiovascular disease\n* Patients with uncontrolled intercurrent illness\n* Patients with psychiatric illness/social situations that would limit compliance with study requirements",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* NSLC lacks oncogenic driver mutations",
            "criterions": [
                {
                    "exact_snippets": "NSLC lacks oncogenic driver mutations",
                    "criterion": "oncogenic driver mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absence of new onset neurological symptoms",
            "criterions": [
                {
                    "exact_snippets": "Absence of new onset neurological symptoms",
                    "criterion": "new onset neurological symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of fewer than ten intracranial lesions",
            "criterions": [
                {
                    "exact_snippets": "Presence of fewer than ten intracranial lesions",
                    "criterion": "intracranial lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Each lesion measures three centimeters or less",
            "criterions": [
                {
                    "exact_snippets": "Each lesion measures three centimeters or less",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "centimeters"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of greater than three months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of greater than three months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ and marrow function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 85 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 85 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Presence of oncogenic driver mutations",
            "criterions": [
                {
                    "exact_snippets": "Presence of oncogenic driver mutations",
                    "criterion": "oncogenic driver mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable lesion located within 10mm of the optic chiasm or optic nerve, or within the brainstem",
            "criterions": [
                {
                    "exact_snippets": "Measurable lesion",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "located within 10mm of the optic chiasm or optic nerve",
                    "criterion": "lesion location",
                    "requirements": [
                        {
                            "requirement_type": "proximity to optic chiasm or optic nerve",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "located ... within the brainstem",
                    "criterion": "lesion location",
                    "requirements": [
                        {
                            "requirement_type": "presence in brainstem",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known leptomeningeal involvement.",
            "criterions": [
                {
                    "exact_snippets": "Known leptomeningeal involvement",
                    "criterion": "leptomeningeal involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Midline shift",
            "criterions": [
                {
                    "exact_snippets": "Midline shift",
                    "criterion": "midline shift",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious non-healing wound, ulcer or bone fracture",
            "criterions": [
                {
                    "exact_snippets": "Serious non-healing wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious non-healing ... ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious non-healing ... bone fracture",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Baseline inability to participate or complete neurocognitive testing",
            "criterions": [
                {
                    "exact_snippets": "Baseline inability to participate or complete neurocognitive testing",
                    "criterion": "neurocognitive testing",
                    "requirements": [
                        {
                            "requirement_type": "ability to participate",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability to complete",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury within 14 days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure (including craniotomy and open brain biopsy)",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "significant traumatic injury within 14 days prior to registration",
                    "criterion": "significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of a non-CNS minor surgical procedure (e.g. core biopsy or fine needle aspiration) within three days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Receipt of a non-CNS minor surgical procedure (e.g. core biopsy or fine needle aspiration) within three days prior to registration",
                    "criterion": "non-CNS minor surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergic reactions attributed to monoclonal antibodies (mAb), compounds of similar chemical or biologic composition to Pembrolizumab",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to monoclonal antibodies (mAb)",
                    "criterion": "allergic reactions to monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "compounds of similar chemical or biologic composition to Pembrolizumab",
                    "criterion": "allergic reactions to compounds similar to Pembrolizumab",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiovascular disease",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with uncontrolled intercurrent illness",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with psychiatric illness/social situations that would limit compliance with study requirements",
            "criterions": [
                {
                    "exact_snippets": "psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "social situations that would limit compliance with study requirements",
                    "criterion": "social situations limiting compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Non-small cell lunch cancer (NSLC) with untreated asymptomatic brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Non-small cell lung cancer (NSLC)",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated asymptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}