{
    "info": {
        "nct_id": "NCT05241873",
        "official_title": "Phase I/II Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "INCLUSION CRITERIA:\n\nAll participants:\n\n* Documented EGFR mutation, based on Next-generation sequencing (NGS) testing of tumor or liquid biopsy analyzed in a local Clinical Laboratory Improvement Amendments (CLIA) (or International Organization for Standardization (ISO) 15189)-certified or equivalent laboratory are required. Redacted copies of laboratory results must be available for Sponsor review.\n* Able to provide a new or archived pretreatment formalin-fixed, paraffin-embedded (FFPE) tumor sample. For participants who received EGFR-targeted therapy subsequent to the most recent archived biopsy, all efforts should be made to obtain a new biopsy unless it is not safe or feasible to obtain one.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Participants must be without seizures for at least 14 days prior to enrollment, and patients who receive treatment with anti-epileptic drugs must be on stable doses for at least 14 days prior to enrollment.\n* Adequate hematological, renal, and hepatic function:\n\nParticipants in Phase 1\n\n* Histologically or cytologically confirmed metastatic NSCLC (stage IVA and IVB per American Joint Committee on Cancer (AJCC) 8th edition) or other metastatic cancers except for primary CNS tumors (Part 1A or Part 2 only).\n* Must have evaluable or measurable disease per RECIST v1.1.\n* Progression on or after or intolerance to most recent systemic therapy.\n\nParticipants in Phase 2\n\n* Histologically or cytologically confirmed metastatic NSCLC (stage IVA and IVB per AJCC 8th edition).\n* Must have measurable disease by RECIST 1.1.\n\nEXCLUSION CRITERIA:\n\n* Have disease that is suitable for local therapy administered with curative intent.\n* Have tumor that harbors known driver alterations (including, but not limited to ROS, BRAF V600E, ALK, RET, HER2, MET, KRAS, NTRK1/2/3, EGFR C797X, or EGFR T790M mutation). These criteria are not applicable to Phase 1 Part 1B.\n* Have NSCLC with mixed cell histology or a tumor with known histologic transformation (NSCLC to SCLC, SCLC to NSCLC, or epithelial to mesenchymal transition).\n\nOther protocol-defined inclusion and exclusion criteria apply"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* Documented EGFR mutation, based on Next-generation sequencing (NGS) testing of tumor or liquid biopsy analyzed in a local Clinical Laboratory Improvement Amendments (CLIA) (or International Organization for Standardization (ISO) 15189)-certified or equivalent laboratory are required. Redacted copies of laboratory results must be available for Sponsor review.",
            "criterions": [
                {
                    "exact_snippets": "Documented EGFR mutation",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Next-generation sequencing (NGS) testing of tumor or liquid biopsy",
                    "criterion": "Next-generation sequencing (NGS) testing",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "tumor",
                                "liquid biopsy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "analyzed in a local Clinical Laboratory Improvement Amendments (CLIA) (or International Organization for Standardization (ISO) 15189)-certified or equivalent laboratory",
                    "criterion": "laboratory certification",
                    "requirements": [
                        {
                            "requirement_type": "certification",
                            "expected_value": [
                                "CLIA",
                                "ISO 15189",
                                "equivalent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Redacted copies of laboratory results must be available",
                    "criterion": "laboratory results availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to provide a new or archived pretreatment formalin-fixed, paraffin-embedded (FFPE) tumor sample. For participants who received EGFR-targeted therapy subsequent to the most recent archived biopsy, all efforts should be made to obtain a new biopsy unless it is not safe or feasible to obtain one.",
            "criterions": [
                {
                    "exact_snippets": "Able to provide a new or archived pretreatment formalin-fixed, paraffin-embedded (FFPE) tumor sample.",
                    "criterion": "FFPE tumor sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participants who received EGFR-targeted therapy subsequent to the most recent archived biopsy, all efforts should be made to obtain a new biopsy unless it is not safe or feasible",
                    "criterion": "new biopsy after EGFR-targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must be without seizures for at least 14 days prior to enrollment, and patients who receive treatment with anti-epileptic drugs must be on stable doses for at least 14 days prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Participants must be without seizures for at least 14 days prior to enrollment",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who receive treatment with anti-epileptic drugs must be on stable doses for at least 14 days prior to enrollment",
                    "criterion": "anti-epileptic drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematological, renal, and hepatic function:",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematological ... function",
                    "criterion": "hematological 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": "Participants in Phase 1",
            "criterions": [
                {
                    "exact_snippets": "Participants in Phase 1",
                    "criterion": "trial phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed metastatic NSCLC (stage IVA and IVB per American Joint Committee on Cancer (AJCC) 8th edition) or other metastatic cancers except for primary CNS tumors (Part 1A or Part 2 only).",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed metastatic NSCLC",
                    "criterion": "metastatic NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IVA and IVB per American Joint Committee on Cancer (AJCC) 8th edition",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IVA",
                                "IVB"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "other metastatic cancers except for primary CNS tumors",
                    "criterion": "metastatic cancers",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "primary CNS tumors"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have evaluable or measurable disease per RECIST v1.1.",
            "criterions": [
                {
                    "exact_snippets": "evaluable or measurable disease per RECIST v1.1",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "evaluation method",
                            "expected_value": "RECIST v1.1"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "evaluable",
                                "measurable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progression on or after or intolerance to most recent systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Progression on or after ... most recent systemic therapy.",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "on or after most recent systemic therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerance to most recent systemic therapy.",
                    "criterion": "treatment intolerance",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "most recent systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Participants in Phase 2",
            "criterions": [
                {
                    "exact_snippets": "Participants in Phase 2",
                    "criterion": "clinical trial phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "Phase 2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed metastatic NSCLC (stage IVA and IVB per AJCC 8th edition).",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed metastatic NSCLC",
                    "criterion": "metastatic NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IVA and IVB per AJCC 8th edition",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IVA",
                                "IVB"
                            ]
                        },
                        {
                            "requirement_type": "edition",
                            "expected_value": "AJCC 8th edition"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have measurable disease by RECIST 1.1.",
            "criterions": [
                {
                    "exact_snippets": "Must have measurable disease by RECIST 1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have disease that is suitable for local therapy administered with curative intent.",
            "criterions": [
                {
                    "exact_snippets": "disease that is suitable for local therapy",
                    "criterion": "disease suitability for local therapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curative intent",
                    "criterion": "intent of local therapy",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have tumor that harbors known driver alterations (including, but not limited to ROS, BRAF V600E, ALK, RET, HER2, MET, KRAS, NTRK1/2/3, EGFR C797X, or EGFR T790M mutation). These criteria are not applicable to Phase 1 Part 1B.",
            "criterions": [
                {
                    "exact_snippets": "tumor that harbors known driver alterations (including, but not limited to ROS, BRAF V600E, ALK, RET, HER2, MET, KRAS, NTRK1/2/3, EGFR C797X, or EGFR T790M mutation)",
                    "criterion": "tumor driver alterations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "ROS",
                                "BRAF V600E",
                                "ALK",
                                "RET",
                                "HER2",
                                "MET",
                                "KRAS",
                                "NTRK1/2/3",
                                "EGFR C797X",
                                "EGFR T790M"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have NSCLC with mixed cell histology or a tumor with known histologic transformation (NSCLC to SCLC, SCLC to NSCLC, or epithelial to mesenchymal transition).",
            "criterions": [
                {
                    "exact_snippets": "Have NSCLC with mixed cell histology",
                    "criterion": "NSCLC with mixed cell histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor with known histologic transformation (NSCLC to SCLC, SCLC to NSCLC, or epithelial to mesenchymal transition)",
                    "criterion": "tumor with known histologic transformation",
                    "requirements": [
                        {
                            "requirement_type": "transformation types",
                            "expected_value": [
                                "NSCLC to SCLC",
                                "SCLC to NSCLC",
                                "epithelial to mesenchymal transition"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other protocol-defined inclusion and exclusion criteria apply",
            "criterions": [
                {
                    "exact_snippets": "Other protocol-defined inclusion and exclusion criteria apply",
                    "criterion": "protocol-defined criteria",
                    "requirements": [
                        {
                            "requirement_type": "application",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "INCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "All participants:",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA:",
            "criterions": []
        }
    ]
}