{
    "info": {
        "nct_id": "NCT00706862",
        "official_title": "FORTIS-C: A Phase 3, Randomized, Placebo-controlled Study of Oral Talactoferrin in Combination With Carboplatin and Paclitaxel as First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer",
        "inclusion_criteria": "* Confirmed locally advanced or metastatic non-small cell lung cancer that is unresectable\n* At least 1 unirradiated target lesion measurable by RECIST\n* Adequate hematologic, renal and hepatic function\n* ECOG 0,1\n* Able to understand and sign an Informed Consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization\n* Received prior systemic anti-cancer therapy for NSCLC\n* History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin or the chemotherapy drugs\n* Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications\n* History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥5 years\n* Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure\n* Serious active infection\n* Psychiatric illness/social situations that would limit study compliance\n* Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic\n* Concurrent radiotherapy or radiotherapy within 4 weeks prior to randomization or previous radiotherapy at the indicator sites (the sites that are to be followed for determination of a response)\n* Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization, except prophylactic use of steroids prior to paclitaxel administration\n* Known HIV positive or on active anti-retroviral therapy\n* Known Hepatitis B surface antigen positive or hepatitis C positive\n* Receipt of any investigational medication within 4 weeks prior to randomization\n* Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and for 30 days after completion of treatment\n* Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment\n* Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Confirmed locally advanced or metastatic non-small cell lung cancer that is unresectable",
            "criterions": [
                {
                    "exact_snippets": "Confirmed locally advanced or metastatic non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 unirradiated target lesion measurable by RECIST",
            "criterions": [
                {
                    "exact_snippets": "At least 1 unirradiated target lesion",
                    "criterion": "unirradiated target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable by RECIST",
                    "criterion": "target lesion measurability",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic, renal and hepatic function",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic ... function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG 0,1",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0,1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to understand and sign an Informed Consent",
            "criterions": [
                {
                    "exact_snippets": "Able to understand",
                    "criterion": "understanding ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign an Informed Consent",
                    "criterion": "ability to sign informed 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": "* Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Presence of brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the patient received brain irradiation, including adequate stereotactic radiosurgery",
                    "criterion": "brain irradiation",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 4 weeks prior to randomization",
                    "criterion": "brain irradiation timing",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "is stable",
                    "criterion": "brain metastases stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic",
                    "criterion": "brain metastases symptoms",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "off steroids for at least 3 weeks prior to randomization",
                    "criterion": "steroid use",
                    "requirements": [
                        {
                            "requirement_type": "time since cessation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received prior systemic anti-cancer therapy for NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Received prior systemic anti-cancer therapy for NSCLC",
                    "criterion": "prior systemic anti-cancer therapy for NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin or the chemotherapy drugs",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin",
                    "criterion": "allergic reactions to compounds similar to talactoferrin",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allergic reactions to ... the chemotherapy drugs",
                    "criterion": "allergic reactions to chemotherapy drugs",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications",
            "criterions": [
                {
                    "exact_snippets": "Any gastrointestinal tract disease",
                    "criterion": "gastrointestinal tract disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other medical condition resulting in the inability to take oral medications",
                    "criterion": "medical condition affecting oral medication intake",
                    "requirements": [
                        {
                            "requirement_type": "effect",
                            "expected_value": "inability to take oral medications"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥5 years",
            "criterions": [
                {
                    "exact_snippets": "History of other malignancies",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal or squamous cell carcinoma of the skin",
                    "criterion": "basal or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated, a) in situ carcinoma of the uterine cervix",
                    "criterion": "in situ carcinoma of the uterine cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated, ... b) prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated, ... c) superficial bladder cancer",
                    "criterion": "superficial bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "other curatively treated solid tumor with no evidence of disease for ≥5 years",
                    "criterion": "other solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        },
                        {
                            "requirement_type": "disease evidence",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "evidence of disease"
                            }
                        },
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled ischemic heart disease",
                    "criterion": "ischemic heart disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious active infection",
            "criterions": [
                {
                    "exact_snippets": "Serious active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Psychiatric illness/social situations that would limit study compliance",
            "criterions": [
                {
                    "exact_snippets": "Psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "impact on study compliance",
                            "expected_value": "limit"
                        }
                    ]
                },
                {
                    "exact_snippets": "social situations that would limit study compliance",
                    "criterion": "social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on study compliance",
                            "expected_value": "limit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled serious chronic disease or conditions",
                    "criterion": "uncontrolled serious chronic disease or conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent radiotherapy or radiotherapy within 4 weeks prior to randomization or previous radiotherapy at the indicator sites (the sites that are to be followed for determination of a response)",
            "criterions": [
                {
                    "exact_snippets": "Concurrent radiotherapy",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy within 4 weeks prior to randomization",
                    "criterion": "recent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "previous radiotherapy at the indicator sites",
                    "criterion": "previous radiotherapy at indicator sites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization, except prophylactic use of steroids prior to paclitaxel administration",
            "criterions": [
                {
                    "exact_snippets": "Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization",
                    "criterion": "systemic corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "except prophylactic use of steroids prior to paclitaxel administration",
                    "criterion": "prophylactic use of steroids",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to paclitaxel administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known HIV positive or on active anti-retroviral therapy",
            "criterions": [
                {
                    "exact_snippets": "Known HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "on active anti-retroviral therapy",
                    "criterion": "anti-retroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known Hepatitis B surface antigen positive or hepatitis C positive",
            "criterions": [
                {
                    "exact_snippets": "Known Hepatitis B surface antigen positive",
                    "criterion": "Hepatitis B surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C positive",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of any investigational medication within 4 weeks prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Receipt of any investigational medication within 4 weeks prior to randomization",
                    "criterion": "investigational medication",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and for 30 days after completion of treatment",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or lactating patients",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant or lactating"
                        }
                    ]
                },
                {
                    "exact_snippets": "fertile female patients with a positive pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "fertile female patients unwilling to use adequate contraception during treatment and for 30 days after completion of treatment",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment",
            "criterions": [
                {
                    "exact_snippets": "Sexually active male patients",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "expected value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "Sexually active male patients",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "expected value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to practice contraception",
                    "criterion": "contraception practice",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "while participating on the study and up to 30 days after completion of treatment",
                    "criterion": "contraception practice duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "while participating on the study and up to 30 days after completion of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian",
            "criterions": [
                {
                    "exact_snippets": "Legal incapacity or limited legal capacity",
                    "criterion": "legal capacity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "full capacity or authorization by a legal guardian"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}