{
    "info": {
        "nct_id": "NCT02754882",
        "official_title": "A Phase 3, Randomised, Double-blind Study to Compare the Efficacy, Safety, PK and Immunogenicity Between SB8 (Proposed Bevacizumab Biosimilar) and Avastin® in Subjects With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer",
        "inclusion_criteria": "1. Aged ≥ 18 years\n2. ECOG performance status of 0-1\n3. Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer\n4. At least one measurable lesion according to RECIST v1.1.\n5. Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma\n2. Sensitizing EGFR mutations or ALK rearrangements\n3. Increased risk of bleeding determined by investigator based on radiographic / clinical findings\n4. History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Aged ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Aged ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ECOG performance status of 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer",
                    "criterion": "non-squamous non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically-confirmed"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "recurrent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. At least one measurable lesion according to RECIST v1.1.",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion according to RECIST v1.1.",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters",
            "criterions": [
                {
                    "exact_snippets": "Able to receive bevacizumab",
                    "criterion": "bevacizumab administration",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to receive ... carboplatin",
                    "criterion": "carboplatin administration",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to receive ... paclitaxel",
                    "criterion": "paclitaxel administration",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate laboratory and clinical parameters",
                    "criterion": "laboratory and clinical parameters",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "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": "1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of small cell carcinoma of the lung",
                    "criterion": "small cell carcinoma of the lung",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Sensitizing EGFR mutations or ALK rearrangements",
            "criterions": [
                {
                    "exact_snippets": "Sensitizing EGFR mutations",
                    "criterion": "EGFR mutations",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "sensitizing"
                        }
                    ]
                },
                {
                    "exact_snippets": "ALK rearrangements",
                    "criterion": "ALK rearrangements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Increased risk of bleeding determined by investigator based on radiographic / clinical findings",
            "criterions": [
                {
                    "exact_snippets": "Increased risk of bleeding determined by investigator based on radiographic / clinical findings",
                    "criterion": "risk of bleeding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "increased"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.",
            "criterions": [
                {
                    "exact_snippets": "History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "setting",
                            "expected_value": "first-line"
                        },
                        {
                            "requirement_type": "disease",
                            "expected_value": "metastatic or recurrent NSCLC"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}