{
    "info": {
        "nct_id": "NCT04487080",
        "official_title": "A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.",
        "inclusion_criteria": "* Participant must have newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation\n* The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care\n* Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow for central analysis of EGFR mutation status and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis)\n* Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level\n* Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease)\n* Participant has an active or past medical history of leptomeningeal disease\n* Participant with untreated spinal cord compression. A participant that has been definitively treated with surgery or radiation and has a stable neurological status for at least 2 weeks prior to randomization is eligible provided they are off corticosteroid treatment or receiving low-dose corticosteroid treatment less than or equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent\n* Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis\n* Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib\n* Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participant must have newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation",
            "criterions": [
                {
                    "exact_snippets": "newly diagnosed",
                    "criterion": "diagnosis status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic non-small cell lung cancer (NSCLC)",
                    "criterion": "cancer type and stage",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-small cell lung cancer (NSCLC)"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment naive",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "treatment naive"
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to curative therapy including surgical resection or chemoradiation",
                    "criterion": "curative therapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care",
            "criterions": [
                {
                    "exact_snippets": "tumor harbors exon 19 deletions (Exon 19del)",
                    "criterion": "tumor exon 19 deletions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor harbors ... Exon 21 L858R substitution",
                    "criterion": "tumor Exon 21 L858R substitution",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow for central analysis of EGFR mutation status and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis)",
            "criterions": [
                {
                    "exact_snippets": "Mandatory submission of unstained tissue from tumor",
                    "criterion": "unstained tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "submission",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient to allow for central analysis of EGFR mutation status",
                    "criterion": "EGFR mutation status analysis",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Mandatory submission of ... blood",
                    "criterion": "blood",
                    "requirements": [
                        {
                            "requirement_type": "submission",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient to allow for ... circulating tumor deoxyribonucleic acid [ctDNA]",
                    "criterion": "circulating tumor deoxyribonucleic acid (ctDNA) analysis",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient to allow for ... digital droplet polymerase chain reaction [ddPCR]",
                    "criterion": "digital droplet polymerase chain reaction (ddPCR) analysis",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient to allow for ... pharmacogenomic analysis",
                    "criterion": "pharmacogenomic analysis",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level",
            "criterions": [
                {
                    "exact_snippets": "toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level",
                    "criterion": "toxicities from prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "CTCAE Grade 1 or baseline level"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy",
            "criterions": [
                {
                    "exact_snippets": "Participant must have at least 1 measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "according to response evaluation criteria in solid tumors (RECIST) v1.1",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "that has not been previously irradiated",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "irradiation status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable lesions should not have been biopsied during screening",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "biopsy status during screening",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "diagnostic biopsy allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provided the baseline tumor assessment scans are performed at least 14 days after the biopsy",
                    "criterion": "baseline tumor assessment scans",
                    "requirements": [
                        {
                            "requirement_type": "timing after biopsy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease)",
            "criterions": [
                {
                    "exact_snippets": "Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease",
                    "criterion": "prior systemic treatment for Stage III or IV disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease",
                    "criterion": "adjuvant or neoadjuvant therapy for Stage I or II disease",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "administered more than 12 months prior to the development of locally advanced or metastatic disease"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has an active or past medical history of leptomeningeal disease",
            "criterions": [
                {
                    "exact_snippets": "active or past medical history of leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant with untreated spinal cord compression. A participant that has been definitively treated with surgery or radiation and has a stable neurological status for at least 2 weeks prior to randomization is eligible provided they are off corticosteroid treatment or receiving low-dose corticosteroid treatment less than or equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent",
            "criterions": [
                {
                    "exact_snippets": "untreated spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "definitively treated with surgery or radiation",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": [
                                "surgery",
                                "radiation"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stable neurological status for at least 2 weeks prior to randomization",
                    "criterion": "neurological status",
                    "requirements": [
                        {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "off corticosteroid treatment",
                    "criterion": "corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "low-dose corticosteroid treatment less than or equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent",
                    "criterion": "corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis",
            "criterions": [
                {
                    "exact_snippets": "active or past medical history of interstitial lung disease (ILD)/pneumonitis",
                    "criterion": "interstitial lung disease (ILD)/pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drug-induced or radiation ILD/pneumonitis",
                    "criterion": "drug-induced or radiation ILD/pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib",
            "criterions": [
                {
                    "exact_snippets": "known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib",
                    "criterion": "allergy, hypersensitivity, or intolerance to excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any contraindication to the use of osimertinib",
                    "criterion": "contraindication to osimertinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study",
            "criterions": [
                {
                    "exact_snippets": "Participant has symptomatic brain metastases",
                    "criterion": "symptomatic brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic or previously treated and stable brain metastases",
                    "criterion": "asymptomatic or previously treated and stable brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}