{
    "info": {
        "nct_id": "NCT05696782",
        "official_title": "Phase II Pilot Study of Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer",
        "inclusion_criteria": "* Patients must have Stage II or Stage III nonsmall cell lung cancer confirmed by histologic or cytologic documentation and by clinical assessment. Staging is defined according to the American Joint Committee on Cancer Staging Manual, 8th Edition (2017).\n* Unresectable or medically inoperable as determined by the investigator.\n* The participant has definitive radiation therapy (e.g., 54 Gy to 66 Gy in 30 to 35 fractions) for lung cancer that is either (a) planned to start within the next 28 days, or (b) currently being administered, or (c) has been completed within the last 14 days.\n* Platinum-based chemotherapy for lung cancer that is either (a) planned to start within the next 28 days, (b) currently being administered, or (c) has been completed within the last 14 days. Chemotherapy must be for at least two cycles and be administered either before radiation therapy (\"induction\" or \"sequential\") or during radiation therapy (\"concurrent\").\n* Consolidation Durvalumab is planned for nonsmall cell lung cancer after radiation and chemotherapy.\n* Eighteen years old or greater.\n* ECOG performance status of 0-2.\n* Life expectancy of greater than three months.\n* Patients with sexual relationships in which either they or their partner may become pregnant must use contraception during the study treatment period.\n* Ability to understand and be willing to sign an IRB-approved informed consent document directly or via a legally authorized representative.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Uncontrolled respiratory symptoms (i.e., cough, dyspnea, fevers, chest pain, or an increase from baseline oxygen requirements) that are interfering with activities of daily living.\n* Nonsmall cell lung cancer is known to have a tumor with a mutation in EGFR associated with sensitivity to first-line therapy with a tyrosine kinase inhibitor (i.e., Ex19del or L858R). Testing for EGFR mutation must have been attempted for study enrollment. If EGFR testing is inconclusive (e.g., the biopsy's quantity or quality is not sufficient for testing to be performed) and there is low clinical suspicion for the presence of an EGFR mutation as determined by the investigator, then the patient is eligible.\n* Prior exposure to an immune checkpoint inhibitor targeting CTLA-4, PD-1, or PD-L1.\n* Active autoimmune disease requiring systemic immunosuppression at the time of enrollment.\n* History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for more than one week).\n* Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Patients who are pregnant or breastfeeding.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have Stage II or Stage III nonsmall cell lung cancer confirmed by histologic or cytologic documentation and by clinical assessment. Staging is defined according to the American Joint Committee on Cancer Staging Manual, 8th Edition (2017).",
            "criterions": [
                {
                    "exact_snippets": "Stage II or Stage III nonsmall cell lung cancer",
                    "criterion": "nonsmall cell lung cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage II",
                                "Stage III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by histologic or cytologic documentation",
                    "criterion": "nonsmall cell lung cancer confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologic",
                                "cytologic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed ... by clinical assessment",
                    "criterion": "nonsmall cell lung cancer confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "clinical assessment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unresectable or medically inoperable as determined by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Unresectable",
                    "criterion": "resectability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "unresectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "medically inoperable",
                    "criterion": "operability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "medically inoperable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has definitive radiation therapy (e.g., 54 Gy to 66 Gy in 30 to 35 fractions) for lung cancer that is either (a) planned to start within the next 28 days, or (b) currently being administered, or (c) has been completed within the last 14 days.",
            "criterions": [
                {
                    "exact_snippets": "definitive radiation therapy (e.g., 54 Gy to 66 Gy in 30 to 35 fractions)",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "definitive"
                        },
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 54,
                                        "unit": "Gy"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 66,
                                        "unit": "Gy"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "fractions",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 30,
                                        "unit": "fractions"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 35,
                                        "unit": "fractions"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lung cancer",
                    "criterion": "lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "planned to start within the next 28 days",
                    "criterion": "radiation therapy start date",
                    "requirements": [
                        {
                            "requirement_type": "planned start",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "currently being administered",
                    "criterion": "radiation therapy administration status",
                    "requirements": [
                        {
                            "requirement_type": "current administration",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "completed within the last 14 days",
                    "criterion": "radiation therapy completion date",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platinum-based chemotherapy for lung cancer that is either (a) planned to start within the next 28 days, (b) currently being administered, or (c) has been completed within the last 14 days. Chemotherapy must be for at least two cycles and be administered either before radiation therapy (\"induction\" or \"sequential\") or during radiation therapy (\"concurrent\").",
            "criterions": [
                {
                    "exact_snippets": "Platinum-based chemotherapy for lung cancer",
                    "criterion": "chemotherapy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "platinum-based"
                        }
                    ]
                },
                {
                    "exact_snippets": "Platinum-based chemotherapy for lung cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "lung cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "planned to start within the next 28 days",
                    "criterion": "chemotherapy timing",
                    "requirements": [
                        {
                            "requirement_type": "planned start",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "currently being administered",
                    "criterion": "chemotherapy timing",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": "currently administered"
                        }
                    ]
                },
                {
                    "exact_snippets": "completed within the last 14 days",
                    "criterion": "chemotherapy timing",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Chemotherapy must be for at least two cycles",
                    "criterion": "chemotherapy cycles",
                    "requirements": [
                        {
                            "requirement_type": "minimum cycles",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cycles"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "administered either before radiation therapy (\"induction\" or \"sequential\") or during radiation therapy (\"concurrent\")",
                    "criterion": "chemotherapy administration timing relative to radiation",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "before radiation therapy",
                                "during radiation therapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Consolidation Durvalumab is planned for nonsmall cell lung cancer after radiation and chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "nonsmall cell lung cancer",
                    "criterion": "nonsmall cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after radiation and chemotherapy",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "radiation",
                                "chemotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eighteen years old or greater.",
            "criterions": [
                {
                    "exact_snippets": "Eighteen years old or greater.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0-2.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients with sexual relationships in which either they or their partner may become pregnant must use contraception during the study treatment period.",
            "criterions": [
                {
                    "exact_snippets": "Patients with sexual relationships in which either they or their partner may become pregnant",
                    "criterion": "sexual relationships with pregnancy risk",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must use contraception during the study treatment period",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and be willing to sign an IRB-approved informed consent document directly or via a legally authorized representative.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be willing to sign an IRB-approved 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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Uncontrolled respiratory symptoms (i.e., cough, dyspnea, fevers, chest pain, or an increase from baseline oxygen requirements) that are interfering with activities of daily living.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled respiratory symptoms (i.e., cough, dyspnea, fevers, chest pain, or an increase from baseline oxygen requirements)",
                    "criterion": "respiratory symptoms",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "cough",
                    "criterion": "cough",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "dyspnea",
                    "criterion": "dyspnea",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "fevers",
                    "criterion": "fevers",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "chest pain",
                    "criterion": "chest pain",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "an increase from baseline oxygen requirements",
                    "criterion": "oxygen requirements",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": "increase from baseline"
                        }
                    ]
                },
                {
                    "exact_snippets": "interfering with activities of daily living",
                    "criterion": "interference with activities of daily living",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nonsmall cell lung cancer is known to have a tumor with a mutation in EGFR associated with sensitivity to first-line therapy with a tyrosine kinase inhibitor (i.e., Ex19del or L858R). Testing for EGFR mutation must have been attempted for study enrollment. If EGFR testing is inconclusive (e.g., the biopsy's quantity or quality is not sufficient for testing to be performed) and there is low clinical suspicion for the presence of an EGFR mutation as determined by the investigator, then the patient is eligible.",
            "criterions": [
                {
                    "exact_snippets": "Nonsmall cell lung cancer",
                    "criterion": "nonsmall cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor with a mutation in EGFR",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sensitivity to first-line therapy with a tyrosine kinase inhibitor (i.e., Ex19del or L858R)",
                    "criterion": "sensitivity to tyrosine kinase inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Testing for EGFR mutation must have been attempted",
                    "criterion": "EGFR mutation testing",
                    "requirements": [
                        {
                            "requirement_type": "attempt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "EGFR testing is inconclusive",
                    "criterion": "EGFR testing result",
                    "requirements": [
                        {
                            "requirement_type": "conclusiveness",
                            "expected_value": "inconclusive"
                        }
                    ]
                },
                {
                    "exact_snippets": "low clinical suspicion for the presence of an EGFR mutation as determined by the investigator",
                    "criterion": "clinical suspicion for EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior exposure to an immune checkpoint inhibitor targeting CTLA-4, PD-1, or PD-L1.",
            "criterions": [
                {
                    "exact_snippets": "Prior exposure to an immune checkpoint inhibitor targeting CTLA-4",
                    "criterion": "immune checkpoint inhibitor exposure",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "CTLA-4"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to an immune checkpoint inhibitor targeting ... PD-1",
                    "criterion": "immune checkpoint inhibitor exposure",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "PD-1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to an immune checkpoint inhibitor targeting ... PD-L1",
                    "criterion": "immune checkpoint inhibitor exposure",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "PD-L1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active autoimmune disease requiring systemic immunosuppression at the time of enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring systemic immunosuppression",
                    "criterion": "systemic immunosuppression",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at the time of enrollment",
                    "criterion": "time of enrollment",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for more than one week).",
            "criterions": [
                {
                    "exact_snippets": "History of autoimmune pneumonitis",
                    "criterion": "autoimmune pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for more than one week)",
                    "criterion": "systemic steroid use",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "mg/day"
                            }
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing or active"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}