{
    "info": {
        "nct_id": "NCT02283320",
        "official_title": "An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* Males or females at least 18 years of age\n* Diagnosis of NSCLC with locally advanced or metastatic disease\n* Positive for KRAS mutation or Squamous cell histology\n* Previously treated with one platinum-based chemotherapy\n* Disease status must be that of measurable and/or evaluable disease\n* Performance status of 0 to 1 on the ECOG Scale\n* Prior chemotherapy completed at least 3 weeks prior to study enrollment\n* Prior radiation therapy allowed to < 25% of the bone marrow\n* Patient compliance and geographic proximity that allow adequate follow-up\n* Adequate organ function\n* Patients with reproductive potential must use contraceptive methods\n* Signed informed consent from patient\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Active infection\n* Pregnancy or planning to become pregnant\n* Breast feeding\n* Serious concomitant systemic disorders\n* Second primary malignancy\n* Patients who are symptomatic from brain metastasis\n* Presence of detectable (by physical exam) third-space fluid collections\n* More than 1 prior cytotoxic chemotherapy regimen for advanced disease\n* Prior treatment with docetaxel\n* History of severe hypersensitivity reaction to polysorbate 80\n* Peripheral neuropathy at study entry\n* Patients known to be HIV positive\n* Patients known to be seropositive for hepatitis C hepatitis B\n* Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Males or females at least 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Males or females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of NSCLC with locally advanced or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of NSCLC",
                    "criterion": "NSCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive for KRAS mutation or Squamous cell histology",
            "criterions": [
                {
                    "exact_snippets": "Positive for KRAS mutation",
                    "criterion": "KRAS mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Squamous cell histology",
                    "criterion": "Squamous cell histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously treated with one platinum-based chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Previously treated with one platinum-based chemotherapy",
                    "criterion": "platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": "previously treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease status must be that of measurable and/or evaluable disease",
            "criterions": [
                {
                    "exact_snippets": "Disease status must be that of measurable and/or evaluable disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status of 0 to 1 on the ECOG Scale",
            "criterions": [
                {
                    "exact_snippets": "Performance status of 0 to 1 on the ECOG Scale",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy completed at least 3 weeks prior to study enrollment",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy completed at least 3 weeks prior to study enrollment",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiation therapy allowed to < 25% of the bone marrow",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation therapy allowed ... < 25% of the bone marrow",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": "<",
                                "value": 25,
                                "unit": "% of the bone marrow"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient compliance and geographic proximity that allow adequate follow-up",
            "criterions": [
                {
                    "exact_snippets": "Patient compliance",
                    "criterion": "patient compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "geographic proximity",
                    "criterion": "geographic proximity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with reproductive potential must use contraceptive methods",
            "criterions": [
                {
                    "exact_snippets": "Patients with reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must use contraceptive methods",
                    "criterion": "contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent from patient",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent from patient",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Active infection",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or planning to become pregnant",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planning to become pregnant",
                    "criterion": "pregnancy intention",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Breast feeding",
            "criterions": [
                {
                    "exact_snippets": "Breast feeding",
                    "criterion": "breast feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious concomitant systemic disorders",
            "criterions": [
                {
                    "exact_snippets": "Serious concomitant systemic disorders",
                    "criterion": "concomitant systemic disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Second primary malignancy",
            "criterions": [
                {
                    "exact_snippets": "Second primary malignancy",
                    "criterion": "second primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are symptomatic from brain metastasis",
            "criterions": [
                {
                    "exact_snippets": "symptomatic from brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of detectable (by physical exam) third-space fluid collections",
            "criterions": [
                {
                    "exact_snippets": "Presence of detectable (by physical exam) third-space fluid collections",
                    "criterion": "third-space fluid collections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "detection method",
                            "expected_value": "physical exam"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 1 prior cytotoxic chemotherapy regimen for advanced disease",
            "criterions": [
                {
                    "exact_snippets": "More than 1 prior cytotoxic chemotherapy regimen for advanced disease",
                    "criterion": "prior cytotoxic chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with docetaxel",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with docetaxel",
                    "criterion": "treatment with docetaxel",
                    "requirements": [
                        {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of severe hypersensitivity reaction to polysorbate 80",
            "criterions": [
                {
                    "exact_snippets": "History of severe hypersensitivity reaction to polysorbate 80",
                    "criterion": "hypersensitivity reaction to polysorbate 80",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Peripheral neuropathy at study entry",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy at study entry",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients known to be HIV positive",
            "criterions": [
                {
                    "exact_snippets": "Patients known to be HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients known to be seropositive for hepatitis C hepatitis B",
            "criterions": [
                {
                    "exact_snippets": "seropositive for hepatitis C",
                    "criterion": "hepatitis C seropositivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "seropositive for ... hepatitis B",
                    "criterion": "hepatitis B seropositivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia",
            "criterions": [
                {
                    "exact_snippets": "Congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bradyarrhythmia",
                    "criterion": "bradyarrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}