{
    "info": {
        "nct_id": "NCT01433172",
        "official_title": "A Randomized Phase I/II Trial Using a GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) Vaccine in Combination With CCL21 for Patients With Stage IV Adenocarcinoma of the Lung",
        "inclusion_criteria": "* Histologically confirmed metastatic adenocarcinoma of the lung\n* Patients must have received and completed first line therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1\n* No external beam radiation therapy within 2 weeks of first vaccine administration\n* No stereotactic radiation therapy within 3 days of first vaccine\n* No targeted therapy within 2 weeks of first vaccine administration\n* No immunomodulatory therapy within 2 weeks of first vaccine administration\n* No chemotherapy within 4 weeks of first vaccine administration\n* During Screening period, no steroid therapy within 4 weeks of first vaccine administration\n* Patient's written informed consent\n* Adequate organ function (measured within a week of beginning treatment):\n\n  * White blood count (WBC) > 3,000/mm³ and absolute neutrophil count (ANC) >/= 1500/mm³\n  * Platelets > 100,000/mm³\n  * Hematocrit > 25%\n  * Bilirubin < 2.0 mg/dL\n  * Creatinine < 2.0 mg/dL, or creatinine clearance > 60 mL/min\n* Patients will be tested for HLA-A0201 as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen; however this result will not be an inclusion criterion.\n* Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter ≥20 mm. With spiral computed tomography (CT) scan, lesion must be ≥10 mm in at least one dimension.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Symptomatic brain metastasis or Uncontrolled central nervous system (CNS) metastasis will not be permitted.\n* Any acute medical problems requiring active intervention\n* Current corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapy\n* Any other pre-existing immunodeficiency condition (including known human immunodeficiency virus [HIV] infection)\n* Any known pre-existing autoimmune disorder\n* History of a second malignancy within the previous 2 years (except non-melanoma skin cancer and cervical in-situ)\n* Patients who have had major surgery without full recovery or major surgery within three weeks of the start of vaccine treatment\n* Pregnant or lactating women: Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4\n* Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study.\n* Patients who at the discretion of the investigator are deemed to have rapidly progressive disease",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed metastatic adenocarcinoma of the lung",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed metastatic adenocarcinoma of the lung",
                    "criterion": "metastatic adenocarcinoma of the lung",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have received and completed first line therapy",
            "criterions": [
                {
                    "exact_snippets": "Patients must have received and completed first line therapy",
                    "criterion": "first line therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No external beam radiation therapy within 2 weeks of first vaccine administration",
            "criterions": [
                {
                    "exact_snippets": "No external beam radiation therapy within 2 weeks of first vaccine administration",
                    "criterion": "external beam radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No stereotactic radiation therapy within 3 days of first vaccine",
            "criterions": [
                {
                    "exact_snippets": "No stereotactic radiation therapy within 3 days of first vaccine",
                    "criterion": "stereotactic radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No targeted therapy within 2 weeks of first vaccine administration",
            "criterions": [
                {
                    "exact_snippets": "No targeted therapy within 2 weeks of first vaccine administration",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No immunomodulatory therapy within 2 weeks of first vaccine administration",
            "criterions": [
                {
                    "exact_snippets": "No immunomodulatory therapy within 2 weeks of first vaccine administration",
                    "criterion": "immunomodulatory therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No chemotherapy within 4 weeks of first vaccine administration",
            "criterions": [
                {
                    "exact_snippets": "No chemotherapy within 4 weeks of first vaccine administration",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* During Screening period, no steroid therapy within 4 weeks of first vaccine administration",
            "criterions": [
                {
                    "exact_snippets": "no steroid therapy within 4 weeks of first vaccine administration",
                    "criterion": "steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient's written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patient's written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function (measured within a week of beginning treatment):",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "measured within a week of beginning treatment",
                    "criterion": "measurement timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within a week of beginning treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* White blood count (WBC) > 3,000/mm³ and absolute neutrophil count (ANC) >/= 1500/mm³",
            "criterions": [
                {
                    "exact_snippets": "White blood count (WBC) > 3,000/mm³",
                    "criterion": "white blood count (WBC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3000,
                                "unit": "mm³"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute neutrophil count (ANC) >/= 1500/mm³",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets > 100,000/mm³",
            "criterions": [
                {
                    "exact_snippets": "Platelets > 100,000/mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hematocrit > 25%",
            "criterions": [
                {
                    "exact_snippets": "Hematocrit > 25%",
                    "criterion": "hematocrit",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin < 2.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin < 2.0 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine < 2.0 mg/dL, or creatinine clearance > 60 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine < 2.0 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance > 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients will be tested for HLA-A0201 as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen; however this result will not be an inclusion criterion.",
            "criterions": [
                {
                    "exact_snippets": "HLA-A0201 as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen",
                    "criterion": "HLA-A0201",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "tested"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter ≥20 mm. With spiral computed tomography (CT) scan, lesion must be ≥10 mm in at least one dimension.",
            "criterions": [
                {
                    "exact_snippets": "Measurable metastatic tumor",
                    "criterion": "metastatic tumor",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Lesions must be accurately measured in at least one dimension with the longest diameter ≥20 mm",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "With spiral computed tomography (CT) scan, lesion must be ≥10 mm in at least one dimension",
                    "criterion": "lesion size with CT scan",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Symptomatic brain metastasis or Uncontrolled central nervous system (CNS) metastasis will not be permitted.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled central nervous system (CNS) metastasis",
                    "criterion": "central nervous system (CNS) metastasis",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any acute medical problems requiring active intervention",
            "criterions": [
                {
                    "exact_snippets": "acute medical problems requiring active intervention",
                    "criterion": "acute medical problems",
                    "requirements": [
                        {
                            "requirement_type": "intervention requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapy",
            "criterions": [
                {
                    "exact_snippets": "Current corticosteroid (other than replacement doses in patients who are hypo-adrenal)",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other pre-existing immunodeficiency condition (including known human immunodeficiency virus [HIV] infection)",
            "criterions": [
                {
                    "exact_snippets": "Any other pre-existing immunodeficiency condition",
                    "criterion": "pre-existing immunodeficiency condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known human immunodeficiency virus [HIV] infection",
                    "criterion": "human immunodeficiency virus (HIV) infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any known pre-existing autoimmune disorder",
            "criterions": [
                {
                    "exact_snippets": "Any known pre-existing autoimmune disorder",
                    "criterion": "autoimmune disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of a second malignancy within the previous 2 years (except non-melanoma skin cancer and cervical in-situ)",
            "criterions": [
                {
                    "exact_snippets": "History of a second malignancy within the previous 2 years",
                    "criterion": "second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except non-melanoma skin cancer and cervical in-situ",
                    "criterion": "second malignancy exceptions",
                    "requirements": [
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "non-melanoma skin cancer",
                                "cervical in-situ"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have had major surgery without full recovery or major surgery within three weeks of the start of vaccine treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had major surgery without full recovery",
                    "criterion": "major surgery recovery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": "not fully recovered"
                        }
                    ]
                },
                {
                    "exact_snippets": "major surgery within three weeks of the start of vaccine treatment",
                    "criterion": "major surgery timing",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women: Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment).",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or lactating women",
                    "criterion": "pregnancy or lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients in reproductive age must agree to use contraceptive methods",
                    "criterion": "use of contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A pregnancy test will be obtained before treatment",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "before treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "2",
                                "3",
                                "4"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study.",
            "criterions": [
                {
                    "exact_snippets": "other significant diseases or disorders",
                    "criterion": "significant diseases or disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who at the discretion of the investigator are deemed to have rapidly progressive disease",
            "criterions": [
                {
                    "exact_snippets": "rapidly progressive disease",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "rapidly progressive"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}