{
    "info": {
        "nct_id": "NCT05223673",
        "official_title": "A Randomised, Open-label, Multi-centre, Two-arm Phase 3 Study Comparing Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil to Trifluridine/Tipiracil Single Agent With a Safety Lead-In Part in Participants With KRAS/NRAS and BRAF Wild Type Metastatic Colorectal Cancer Previously Treated With Standard Treatment and Anti-EGFR Therapy",
        "inclusion_criteria": "* Histologically or cytologically confirmed adenocarcinoma of metastatic colorectal cancer (mCRC), not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumour without RAS (KRAS and NRAS) and BRAF V600E mutations based on Circulating tumour DNA (ctDNA) screening blood test analysis\n* Participants with measurable or non-measurable lesion\n* Participants must have received at least 2 prior regimens of standard chemotherapy for mCRC and had demonstrated progressive disease or intolerance to their last regimen\n* Participants should have received previous treatment with commercially available anti-EGFR mAbs for ≥ 4 months\n* Estimated life expectancy ≥ 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate haematological, renal and hepatic function\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnancy, possibility of becoming pregnant during the study, breastfeeding woman\n* Patients currently receiving or having received anticancer therapies within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part).\n* Major surgery within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part) or participants who have not recovered from side effects of the surgery\n* Participants with serious/active/uncontrolled infection\n* Known clinically significant cardiovascular disease or condition\n* Significant gastrointestinal abnormality\n* Skin rash of Grade > 1 from prior anti-EGFR at the time of inclusion (Safety Lead-in part) or randomization (Phase 3 part), or any other skin toxicity precluding participation in the study according to investigator's discretion.\n* Treatment with systemic immunosuppressive therapy within 4 weeks prior to inclusion (Safety Lead-in part) or randomization (Phase 3 part)\n* Prior radiotherapy if completed less than 4 weeks before the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part)\n* Patients with other malignancies",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed adenocarcinoma of metastatic colorectal cancer (mCRC), not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumour without RAS (KRAS and NRAS) and BRAF V600E mutations based on Circulating tumour DNA (ctDNA) screening blood test analysis",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed adenocarcinoma of metastatic colorectal cancer (mCRC)",
                    "criterion": "adenocarcinoma of metastatic colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumour",
                    "criterion": "surgical intervention amenability",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without RAS (KRAS and NRAS) and BRAF V600E mutations",
                    "criterion": "RAS and BRAF V600E mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "based on Circulating tumour DNA (ctDNA) screening blood test analysis",
                    "criterion": "Circulating tumour DNA (ctDNA) screening blood test",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "blood test analysis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with measurable or non-measurable lesion",
            "criterions": [
                {
                    "exact_snippets": "measurable or non-measurable lesion",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have received at least 2 prior regimens of standard chemotherapy for mCRC and had demonstrated progressive disease or intolerance to their last regimen",
            "criterions": [
                {
                    "exact_snippets": "Participants must have received at least 2 prior regimens of standard chemotherapy for mCRC",
                    "criterion": "prior chemotherapy regimens for mCRC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "demonstrated progressive disease",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerance to their last regimen",
                    "criterion": "intolerance to last regimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants should have received previous treatment with commercially available anti-EGFR mAbs for ≥ 4 months",
            "criterions": [
                {
                    "exact_snippets": "received previous treatment with commercially available anti-EGFR mAbs for ≥ 4 months",
                    "criterion": "previous treatment with anti-EGFR mAbs",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated life expectancy ≥ 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy ≥ 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate haematological, renal and hepatic function",
            "criterions": [
                {
                    "exact_snippets": "Adequate haematological ... function",
                    "criterion": "haematological 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": "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": "* Pregnancy, possibility of becoming pregnant during the study, breastfeeding woman",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "possibility of becoming pregnant during the study",
                    "criterion": "possibility of becoming pregnant",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding woman",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients currently receiving or having received anticancer therapies within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part).",
            "criterions": [
                {
                    "exact_snippets": "Patients currently receiving or having received anticancer therapies within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part).",
                    "criterion": "anticancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part) or participants who have not recovered from side effects of the surgery",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part)",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "participants who have not recovered from side effects of the surgery",
                    "criterion": "recovery from surgery side effects",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with serious/active/uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "serious/active/uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "serious",
                                "active",
                                "uncontrolled"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known clinically significant cardiovascular disease or condition",
            "criterions": [
                {
                    "exact_snippets": "Known clinically significant cardiovascular disease or condition",
                    "criterion": "cardiovascular disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant gastrointestinal abnormality",
            "criterions": [
                {
                    "exact_snippets": "Significant gastrointestinal abnormality",
                    "criterion": "gastrointestinal abnormality",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Skin rash of Grade > 1 from prior anti-EGFR at the time of inclusion (Safety Lead-in part) or randomization (Phase 3 part), or any other skin toxicity precluding participation in the study according to investigator's discretion.",
            "criterions": [
                {
                    "exact_snippets": "Skin rash of Grade > 1 from prior anti-EGFR",
                    "criterion": "skin rash",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade"
                            }
                        },
                        {
                            "requirement_type": "cause",
                            "expected_value": "prior anti-EGFR"
                        }
                    ]
                },
                {
                    "exact_snippets": "any other skin toxicity precluding participation in the study according to investigator's discretion",
                    "criterion": "skin toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "precluding participation in the study according to investigator's discretion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with systemic immunosuppressive therapy within 4 weeks prior to inclusion (Safety Lead-in part) or randomization (Phase 3 part)",
            "criterions": [
                {
                    "exact_snippets": "Treatment with systemic immunosuppressive therapy within 4 weeks prior to inclusion (Safety Lead-in part) or randomization (Phase 3 part)",
                    "criterion": "systemic immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks prior to inclusion or randomization"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiotherapy if completed less than 4 weeks before the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part)",
            "criterions": [
                {
                    "exact_snippets": "Prior radiotherapy if completed less than 4 weeks before the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part)",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with other malignancies",
            "criterions": [
                {
                    "exact_snippets": "Patients with other malignancies",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}