{
    "info": {
        "nct_id": "NCT02733159",
        "official_title": "A Phase II Trial of Pembrolizumab in Patients With Non-small Cell Lung Cancer and a Performance Status of 2",
        "inclusion_criteria": "* Histologically confirmed PD-L1 status defined NSCLC. Biopsy must be within 70 days of first treatment with pembrolizumab.\n* Eastern Cooperative Oncology Group (ECOG) performance status 2.\n* Life expectancy > 12 weeks.\n* Uni-dimensionally measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1\n* Computerised Tomography (CT) scan of chest and abdomen within 28 days of starting pembrolizumab.\n* Adequate haematological function:\n\n  * Platelet count ≥100 x 109 /L.\n  * Neutrophils ≥1.5 x 109/L.\n  * Haemoglobin ≥ 90 g/L.\n* Adequate hepatic function:\n\n  * Serum bilirubin ≤1.5 x upper limit of normal (ULN).\n  * Serum transaminases ≤2.5 x ULN.\n* Adequate renal function: Creatinine clearance <1.5 times ULN concurrent with creatinine clearance >50 ml/min.\n* Provision of signed and dated, written informed consent prior to any trial specific procedures, sampling and analyses.\n\nCore\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who do not meet the criteria of performance status = 2 on the ECOG Performance scale.\n* Untreated symptomatic brain or leptomeningeal metastatic disease.\n* Medical or psychiatric conditions compromising informed consent.\n* Any medical condition which in the opinion of the investigator would compromise the ability of the patient to participate in the trial or which would jeopardise compliance with the protocol.\n* Radiotherapy within 28 days of trial treatment.\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* Chronic usage of steroids or other immunosuppressant medication.\n* Previous history of pneumonitis.\n* Any evidence of clinical autoimmunity.",
        "miscellaneous_criteria": "Core"
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed PD-L1 status defined NSCLC. Biopsy must be within 70 days of first treatment with pembrolizumab.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Histologically confirmed PD-L1 status"
                    ],
                    "criterion": "PD-L1 status",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "NSCLC"
                    ],
                    "criterion": "NSCLC",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Biopsy must be within 70 days of first treatment"
                    ],
                    "criterion": "biopsy",
                    "requirement_type": "timing",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 70
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 2.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Eastern Cooperative Oncology Group (ECOG) performance status"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "value",
                    "expected_value": "2"
                }
            ]
        },
        {
            "line": "* Life expectancy > 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life expectancy > 12 weeks"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 12
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Uni-dimensionally measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1",
            "criterions": [
                {
                    "exact_snippets": [
                        "Uni-dimensionally measurable disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "measurability",
                    "expected_value": "uni-dimensionally measurable"
                },
                {
                    "exact_snippets": [
                        "Response Evaluation Criteria in Solid Tumours (RECIST) v1.1"
                    ],
                    "criterion": "evaluation criteria",
                    "requirement_type": "version",
                    "expected_value": "RECIST v1.1"
                }
            ]
        },
        {
            "line": "* Adequate haematological function:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Adequate haematological function"
                    ],
                    "criterion": "haematological function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Platelet count ≥100 x 109 /L.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Platelet count ≥100 x 109 /L"
                    ],
                    "criterion": "platelet",
                    "requirement_type": "count",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 100000000000
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Neutrophils ≥1.5 x 109/L.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Neutrophils ≥1.5 x 109/L"
                    ],
                    "criterion": "neutrophils",
                    "requirement_type": "count",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Haemoglobin ≥ 90 g/L.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Haemoglobin ≥ 90 g/L"
                    ],
                    "criterion": "haemoglobin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 90
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Adequate hepatic function:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Adequate hepatic function"
                    ],
                    "criterion": "hepatic function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Serum bilirubin ≤1.5 x upper limit of normal (ULN).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Serum bilirubin",
                        "≤1.5 x upper limit of normal (ULN)"
                    ],
                    "criterion": "serum bilirubin",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Serum transaminases ≤2.5 x ULN.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Serum transaminases ≤2.5 x ULN"
                    ],
                    "criterion": "serum transaminases",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Adequate renal function: Creatinine clearance <1.5 times ULN concurrent with creatinine clearance >50 ml/min.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Creatinine clearance <1.5 times ULN"
                    ],
                    "criterion": "creatinine clearance",
                    "requirement_type": "comparison",
                    "expected_value": {
                        "operator": "<",
                        "value": 1.5
                    }
                },
                {
                    "exact_snippets": [
                        "creatinine clearance >50 ml/min"
                    ],
                    "criterion": "creatinine clearance",
                    "requirement_type": "comparison",
                    "expected_value": {
                        "operator": ">",
                        "value": 50
                    }
                }
            ]
        },
        {
            "line": "* Provision of signed and dated, written informed consent prior to any trial specific procedures, sampling and analyses.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Provision of signed and dated, written informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "provision",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who do not meet the criteria of performance status = 2 on the ECOG Performance scale.",
            "criterions": [
                {
                    "exact_snippets": [
                        "performance status = 2",
                        "ECOG Performance scale"
                    ],
                    "criterion": "performance status",
                    "requirement_type": "ECOG scale",
                    "expected_value": {
                        "operator": "=",
                        "value": 2
                    }
                }
            ]
        },
        {
            "line": "* Untreated symptomatic brain or leptomeningeal metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Untreated symptomatic brain"
                    ],
                    "criterion": "brain metastatic disease",
                    "requirement_type": "treatment status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Untreated symptomatic brain"
                    ],
                    "criterion": "brain metastatic disease",
                    "requirement_type": "symptom presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Untreated symptomatic",
                        "leptomeningeal metastatic disease"
                    ],
                    "criterion": "leptomeningeal metastatic disease",
                    "requirement_type": "treatment status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Untreated symptomatic",
                        "leptomeningeal metastatic disease"
                    ],
                    "criterion": "leptomeningeal metastatic disease",
                    "requirement_type": "symptom presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Medical or psychiatric conditions compromising informed consent.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Medical or psychiatric conditions"
                    ],
                    "criterion": "medical condition",
                    "requirement_type": "compromising informed consent",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Medical or psychiatric conditions"
                    ],
                    "criterion": "psychiatric condition",
                    "requirement_type": "compromising informed consent",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Any medical condition which in the opinion of the investigator would compromise the ability of the patient to participate in the trial or which would jeopardise compliance with the protocol.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Any medical condition",
                        "would compromise the ability of the patient to participate in the trial"
                    ],
                    "criterion": "medical condition",
                    "requirement_type": "impact on trial participation",
                    "expected_value": "compromise"
                },
                {
                    "exact_snippets": [
                        "Any medical condition",
                        "would jeopardise compliance with the protocol"
                    ],
                    "criterion": "medical condition",
                    "requirement_type": "impact on protocol compliance",
                    "expected_value": "jeopardise"
                }
            ]
        },
        {
            "line": "* Radiotherapy within 28 days of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Radiotherapy within 28 days"
                    ],
                    "criterion": "radiotherapy",
                    "requirement_type": "time since treatment",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 28
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Active autoimmune disease that has required systemic treatment in past 2 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Active autoimmune disease"
                    ],
                    "criterion": "autoimmune disease",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "autoimmune disease that has required systemic treatment"
                    ],
                    "criterion": "autoimmune disease",
                    "requirement_type": "treatment requirement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "in past 2 years"
                    ],
                    "criterion": "treatment requirement",
                    "requirement_type": "time frame",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Chronic usage of steroids or other immunosuppressant medication.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Chronic usage of steroids"
                    ],
                    "criterion": "steroids",
                    "requirement_type": "usage",
                    "expected_value": "chronic"
                },
                {
                    "exact_snippets": [
                        "Chronic usage of",
                        "other immunosuppressant medication"
                    ],
                    "criterion": "immunosuppressant medication",
                    "requirement_type": "usage",
                    "expected_value": "chronic"
                }
            ]
        },
        {
            "line": "* Previous history of pneumonitis.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previous history of pneumonitis"
                    ],
                    "criterion": "pneumonitis",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Any evidence of clinical autoimmunity.",
            "criterions": [
                {
                    "exact_snippets": [
                        "evidence of clinical autoimmunity"
                    ],
                    "criterion": "clinical autoimmunity",
                    "requirement_type": "evidence",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Computerised Tomography (CT) scan of chest and abdomen within 28 days of starting pembrolizumab.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Computerised Tomography (CT) scan of chest"
                    ],
                    "criterion": "CT scan of chest",
                    "requirement_type": "timing",
                    "expected_value": "within 28 days of starting pembrolizumab"
                },
                {
                    "exact_snippets": [
                        "Computerised Tomography (CT) scan of abdomen"
                    ],
                    "criterion": "CT scan of abdomen",
                    "requirement_type": "timing",
                    "expected_value": "within 28 days of starting pembrolizumab"
                }
            ]
        },
        {
            "line": "Core",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Core",
            "criterions": []
        }
    ]
}