{
    "info": {
        "nct_id": "NCT01219348",
        "official_title": "IDO Peptid Vaccination in Combination With Immune Stimulating Agent Aldara and the Adjuvant Montanide, for Treatment of Patients With Locally Advanced or Metastatic Non Small-cell Lung Cancer. A First-in-man Phase I Trial.",
        "inclusion_criteria": "1. Histological or cytological verified non small cell lung cancer 2. Metastatic or locally advanced incurable stage III-IV NSCLC 3. Patients need to be off chemotherapy treatment 4. Evaluable disease according to RECIST V. 1,1 criteria 5. Patients must be HLA-A2 positive 6. Patients > 18 years old 7. Performance status 0-1 8. Life expectancy of > 3 months 9. Acceptable bone marrow function, defined as\n\na. White blood cell count > 2,5 * 109 /l b. Neutrophil count> 1,5 * 109 /l c. Platelet count > 75 * 109/l 10. Creatinin measured < 2,5 * upper limit value 11. Acceptable liver function, defined as\n\n1. ASAT < 100 U/L\n2. Bilirubin < 30 U/L 12. Women with child-bearing potential must have controlled s-hcg before inclusion 13. Patients must provide written informed concent before inclusion 13. Termination of chemotherapy treatment > 28 days before inclusion\n\n   14. Termination of radiotherapy treatment > 28 days before inclusion\n\n   15. Inclusion at least > 4 weeks after complicated gastric surgery\n\n   -\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Other malignancies except from non-melanoma skin cancer in the previous 5 years until study inclusion\n   2. Brain metastasis are allowed after radical excision, and if the patient at least 1 month afterwards is not in clinical or radiographic progression\n   3. Patients with active gastric ulcer disease; patients taking antacid treatment can be included.\n   4. Severe medical condition, severe asthma, severe COLD, severe arteriosclerosis or diabetic disease\n   5. Acute or chronic infection (ie. HIV, hepatitis, tuberculosis)\n   6. Severe allergic reaction or previous anaphylactic shock\n   7. Autoimmune diseases (ie. autoimmune neutropenia/thrombopenia, hæmolytic anaemia, systemic lupus erythematosis, Sjøgrens disease, sclerodermia, Goodpastures syndrome, Addisons disease, active Graves disease)\n   8. Pregnant or lactating women\n   9. Psychiatric disease, which can influence compliance\n   10. Known hypersensitivity towards the adjuvance Montanide, the Aldara creme, or adhesive tape.\n   11. Treatment with immunosuppressive therapy (ie. dexamethasone, methotrexate)\n   12. Treatment with other experimental therapy\n   13. Treatment with other anti-cancer therapy, except from treatment of osteoporosis\n   14. No systemic chemotherapy, immunotherapy or radiation therapy (except locally) are allowed until 28 days before inclusion.\n\n       -",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histological or cytological verified non small cell lung cancer 2. Metastatic or locally advanced incurable stage III-IV NSCLC 3. Patients need to be off chemotherapy treatment 4. Evaluable disease according to RECIST V. 1,1 criteria 5. Patients must be HLA-A2 positive 6. Patients > 18 years old 7. Performance status 0-1 8. Life expectancy of > 3 months 9. Acceptable bone marrow function, defined as",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological verified non small cell lung cancer",
                    "criterion": "non small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "verification",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Metastatic or locally advanced incurable stage III-IV NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients need to be off chemotherapy treatment",
                    "criterion": "chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "off"
                        }
                    ]
                },
                {
                    "exact_snippets": "Evaluable disease according to RECIST V. 1,1 criteria",
                    "criterion": "evaluable disease",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST V. 1,1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must be HLA-A2 positive",
                    "criterion": "HLA-A2",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients > 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status 0-1",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy of > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "a. White blood cell count > 2,5 * 109 /l b. Neutrophil count> 1,5 * 109 /l c. Platelet count > 75 * 109/l 10. Creatinin measured < 2,5 * upper limit value 11. Acceptable liver function, defined as",
            "criterions": [
                {
                    "exact_snippets": "White blood cell count > 2,5 * 109 /l",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "* 10^9 /l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Neutrophil count> 1,5 * 109 /l",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "* 10^9 /l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count > 75 * 109/l",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 75,
                                "unit": "* 10^9 /l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinin measured < 2,5 * upper limit value",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "* upper limit value"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Acceptable liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "acceptable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. ASAT < 100 U/L",
            "criterions": [
                {
                    "exact_snippets": "ASAT < 100 U/L",
                    "criterion": "ASAT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "U/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Termination of radiotherapy treatment > 28 days before inclusion",
            "criterions": [
                {
                    "exact_snippets": "Termination of radiotherapy treatment > 28 days before inclusion",
                    "criterion": "termination of radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since termination",
                            "expected_value": {
                                "operator": ">",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Inclusion at least > 4 weeks after complicated gastric surgery",
            "criterions": [
                {
                    "exact_snippets": "> 4 weeks after complicated gastric surgery",
                    "criterion": "time since complicated gastric surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Other malignancies except from non-melanoma skin cancer in the previous 5 years until study inclusion",
            "criterions": [
                {
                    "exact_snippets": "Other malignancies except from non-melanoma skin cancer",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the previous 5 years until study inclusion",
                    "criterion": "time since other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Brain metastasis are allowed after radical excision, and if the patient at least 1 month afterwards is not in clinical or radiographic progression",
            "criterions": [
                {
                    "exact_snippets": "Brain metastasis are allowed",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after radical excision",
                    "criterion": "radical excision",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "completed"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 1 month afterwards",
                    "criterion": "time since radical excision",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not in clinical or radiographic progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not in progression"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with active gastric ulcer disease; patients taking antacid treatment can be included.",
            "criterions": [
                {
                    "exact_snippets": "Patients with active gastric ulcer disease",
                    "criterion": "gastric ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients taking antacid treatment",
                    "criterion": "antacid treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Severe medical condition, severe asthma, severe COLD, severe arteriosclerosis or diabetic disease",
            "criterions": [
                {
                    "exact_snippets": "Severe medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe asthma",
                    "criterion": "asthma",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe COLD",
                    "criterion": "COLD",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe arteriosclerosis",
                    "criterion": "arteriosclerosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "diabetic disease",
                    "criterion": "diabetic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Acute or chronic infection (ie. HIV, hepatitis, tuberculosis)",
            "criterions": [
                {
                    "exact_snippets": "Acute or chronic infection (ie. HIV, hepatitis, tuberculosis)",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Severe allergic reaction or previous anaphylactic shock",
            "criterions": [
                {
                    "exact_snippets": "Severe allergic reaction",
                    "criterion": "allergic reaction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "previous anaphylactic shock",
                    "criterion": "anaphylactic shock",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Autoimmune diseases (ie. autoimmune neutropenia/thrombopenia, hæmolytic anaemia, systemic lupus erythematosis, Sjøgrens disease, sclerodermia, Goodpastures syndrome, Addisons disease, active Graves disease)",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune diseases (ie. autoimmune neutropenia/thrombopenia, hæmolytic anaemia, systemic lupus erythematosis, Sjøgrens disease, sclerodermia, Goodpastures syndrome, Addisons disease, active Graves disease)",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "autoimmune neutropenia",
                                "thrombopenia",
                                "hæmolytic anaemia",
                                "systemic lupus erythematosis",
                                "Sjøgrens disease",
                                "sclerodermia",
                                "Goodpastures syndrome",
                                "Addisons disease",
                                "active Graves disease"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Psychiatric disease, which can influence compliance",
            "criterions": [
                {
                    "exact_snippets": "Psychiatric disease",
                    "criterion": "psychiatric disease",
                    "requirements": [
                        {
                            "requirement_type": "influence on compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Known hypersensitivity towards the adjuvance Montanide, the Aldara creme, or adhesive tape.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity towards the adjuvance Montanide",
                    "criterion": "hypersensitivity to Montanide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity towards ... the Aldara creme",
                    "criterion": "hypersensitivity to Aldara creme",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity towards ... adhesive tape",
                    "criterion": "hypersensitivity to adhesive tape",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Treatment with immunosuppressive therapy (ie. dexamethasone, methotrexate)",
            "criterions": [
                {
                    "exact_snippets": "Treatment with immunosuppressive therapy (ie. dexamethasone, methotrexate)",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Treatment with other experimental therapy",
            "criterions": [
                {
                    "exact_snippets": "Treatment with other experimental therapy",
                    "criterion": "treatment with other experimental therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Treatment with other anti-cancer therapy, except from treatment of osteoporosis",
            "criterions": [
                {
                    "exact_snippets": "Treatment with other anti-cancer therapy",
                    "criterion": "other anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except from treatment of osteoporosis",
                    "criterion": "treatment of osteoporosis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. No systemic chemotherapy, immunotherapy or radiation therapy (except locally) are allowed until 28 days before inclusion.",
            "criterions": [
                {
                    "exact_snippets": "No systemic chemotherapy ... are allowed until 28 days before inclusion.",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days before inclusion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... immunotherapy ... are allowed until 28 days before inclusion.",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days before inclusion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... radiation therapy (except locally) are allowed until 28 days before inclusion.",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days before inclusion"
                            }
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "except locally"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "2. Bilirubin < 30 U/L 12. Women with child-bearing potential must have controlled s-hcg before inclusion 13. Patients must provide written informed concent before inclusion 13. Termination of chemotherapy treatment > 28 days before inclusion",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin < 30 U/L",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "U/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Women with child-bearing potential must have controlled s-hcg before inclusion",
                    "criterion": "s-hcg level",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must provide written informed consent before inclusion",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Termination of chemotherapy treatment > 28 days before inclusion",
                    "criterion": "termination of chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since termination",
                            "expected_value": {
                                "operator": ">",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "-",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "-",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}