{
    "info": {
        "nct_id": "NCT04515394",
        "official_title": "A Phase II Single-Arm Study to Investigate Tepotinib Combined With Cetuximab in RAS/BRAF Wild-Type Left-Sided mCRC Patients Having Acquired Resistance to Anti-EGFR Antibody Targeting Therapy Due to MET Amplification (PERSPECTIVE)",
        "inclusion_criteria": "* Advanced (locally advanced or metastatic) left sided (from splenic flexure to rectum - National Comprehensive Cancer Network [NCCN] version 4.2020) colorectal cancer (CRC) with RAS/BRAF wild-type at study entry confirmed prior to enrollment, with previous anti-epidermal growth factor receptor (anti-EGFR) therapy and acquired resistance on the most recent anti-EGFR monoclonal antibody therapy (panitumumab or cetuximab) by radiological documentation of disease progression according to RECIST Version 1.1\n* Mesenchymal epithelial transition (MET) amplification detected by a positive liquid biopsy and/or tissue with appropriate regulatory status (collected after disease progression of the previous anti-EGFR therapy)\n* Measurable disease by Investigator in accordance with RECIST Version 1.1\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n* Life expectancy greater than 3 months\n* Participants having at least one systemic treatment for mCRC including 1 anti-EGFR monoclonal antibody therapy as the most recent line of therapy for mCRC before study treatment and must have shown a radiologically confirmed by RECIST Version 1.1 complete response (CR) or partial response (PR), both for at least 4 months or stable disease (SD) for at least 6 months to that therapy prior to disease progression\n* Less than 2 months between the last administration of the most recent EGFR containing regimen and first dosing in this study\n* Adequate hematological function, hepatic and renal functions as defined in the protocol\n* Signed and dated informed consent indicating that the participants had been informed of all the pertinent aspects of the trial prior to enrollment\n* Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies\n* Other protocol defined inclusion criteria could apply\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS metastases. Also excluded are participants with carcinomatous meningitis\n* Participants who have brain metastasis as the only measurable lesion\n* Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for anti-cancer purposes, targeted therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to the first dose of study intervention, except for the anti-EGFR containing regimen including associated chemotherapy if applicable, which may be continued until enrollment of the participant in the study\n* Any unresolved toxicity Grade 2 or more according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, from previous anticancer therapy excluding neuropathy, alopecia and rash\n* Severe hypersensitivity reactions to monoclonal antibodies (Grade greater than or equal to [>=] 3 NCI-CTCAE v 5.0), any history of anaphylaxis, or uncontrolled asthma (i.e., 3 or more occurrences of partially controlled asthma)\n* Discontinuation of the most recent cetuximab or panitumumab containing therapy due to an adverse event\n* Prior treatment with other agents targeting the hepatocyte growth factor (HGF)/Mesenchymal epithelial transition (MET) pathway\n* Impaired cardiac function: Left ventricular ejection fraction less than [<] 45 percent [%] defined by echocardiography (a screening assessment not required for participants without a history of congestive heart failure unless clinically indicated); Serious arrhythmia; Unstable angina pectoris; New York Heart Association heart failure Class III and IV; Myocardial infarction within the last 12 months prior to study entry and Symptomatic pericardial effusion; Corrected QT interval by Fridericia (QTcF) greater than (>) 480 milliseconds (ms)\n* Hypertension uncontrolled by standard therapies (not stabilized to less than [< ]150/90 millimeter of mercury [mmHg])\n* History of neoplasm other than mCRC\n* History of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the test products\n* Known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C virus\n* Major surgery within 28 days prior to Day 1 of study intervention\n* History of Interstitial lung disease (ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment\n* Other protocol defined exclusion criteria could apply",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Advanced (locally advanced or metastatic) left sided (from splenic flexure to rectum - National Comprehensive Cancer Network [NCCN] version 4.2020) colorectal cancer (CRC) with RAS/BRAF wild-type at study entry confirmed prior to enrollment, with previous anti-epidermal growth factor receptor (anti-EGFR) therapy and acquired resistance on the most recent anti-EGFR monoclonal antibody therapy (panitumumab or cetuximab) by radiological documentation of disease progression according to RECIST Version 1.1",
            "criterions": [
                {
                    "exact_snippets": "Advanced (locally advanced or metastatic) left sided (from splenic flexure to rectum - National Comprehensive Cancer Network [NCCN] version 4.2020) colorectal cancer (CRC)",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "left sided (from splenic flexure to rectum)"
                        }
                    ]
                },
                {
                    "exact_snippets": "RAS/BRAF wild-type at study entry confirmed prior to enrollment",
                    "criterion": "RAS/BRAF status",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "wild-type"
                        }
                    ]
                },
                {
                    "exact_snippets": "previous anti-epidermal growth factor receptor (anti-EGFR) therapy",
                    "criterion": "anti-EGFR therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acquired resistance on the most recent anti-EGFR monoclonal antibody therapy (panitumumab or cetuximab) by radiological documentation of disease progression according to RECIST Version 1.1",
                    "criterion": "acquired resistance to anti-EGFR therapy",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "radiological documentation of disease progression according to RECIST Version 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mesenchymal epithelial transition (MET) amplification detected by a positive liquid biopsy and/or tissue with appropriate regulatory status (collected after disease progression of the previous anti-EGFR therapy)",
            "criterions": [
                {
                    "exact_snippets": "Mesenchymal epithelial transition (MET) amplification detected",
                    "criterion": "MET amplification",
                    "requirements": [
                        {
                            "requirement_type": "detection",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive liquid biopsy",
                    "criterion": "liquid biopsy",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "tissue with appropriate regulatory status",
                    "criterion": "tissue regulatory status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "appropriate"
                        }
                    ]
                },
                {
                    "exact_snippets": "collected after disease progression of the previous anti-EGFR therapy",
                    "criterion": "tissue collection timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after disease progression of the previous anti-EGFR therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease by Investigator in accordance with RECIST Version 1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease ... in accordance with RECIST Version 1.1",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST Version 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1",
                    "criterion": "Eastern Cooperative Oncology Group Performance Status (ECOG PS)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy greater than 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy greater than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants having at least one systemic treatment for mCRC including 1 anti-EGFR monoclonal antibody therapy as the most recent line of therapy for mCRC before study treatment and must have shown a radiologically confirmed by RECIST Version 1.1 complete response (CR) or partial response (PR), both for at least 4 months or stable disease (SD) for at least 6 months to that therapy prior to disease progression",
            "criterions": [
                {
                    "exact_snippets": "Participants having at least one systemic treatment for mCRC",
                    "criterion": "systemic treatment for mCRC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "treatment"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "1 anti-EGFR monoclonal antibody therapy as the most recent line of therapy for mCRC",
                    "criterion": "anti-EGFR monoclonal antibody therapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "most recent line of therapy for mCRC"
                        }
                    ]
                },
                {
                    "exact_snippets": "radiologically confirmed by RECIST Version 1.1 complete response (CR) or partial response (PR), both for at least 4 months",
                    "criterion": "response to therapy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "radiologically confirmed by RECIST Version 1.1"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "complete response (CR)",
                                "partial response (PR)"
                            ]
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stable disease (SD) for at least 6 months",
                    "criterion": "stable disease (SD)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Less than 2 months between the last administration of the most recent EGFR containing regimen and first dosing in this study",
            "criterions": [
                {
                    "exact_snippets": "Less than 2 months between the last administration of the most recent EGFR containing regimen and first dosing in this study",
                    "criterion": "time since last EGFR regimen",
                    "requirements": [
                        {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed and dated informed consent indicating that the participants had been informed of all the pertinent aspects of the trial prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "Signed and dated informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed and dated"
                        }
                    ]
                },
                {
                    "exact_snippets": "participants had been informed of all the pertinent aspects of the trial",
                    "criterion": "participant information",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": "all pertinent aspects of the trial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies",
            "criterions": [
                {
                    "exact_snippets": "Contraceptive use by males or females ... consistent with local regulations on contraception methods",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "consistency with local regulations",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other protocol defined inclusion criteria could apply",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined inclusion criteria",
                    "criterion": "protocol defined inclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "* Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS metastases. Also excluded are participants with carcinomatous meningitis",
            "criterions": [
                {
                    "exact_snippets": "symptomatic central nervous system (CNS) metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "neurologically unstable",
                    "criterion": "neurological stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "required increasing doses of steroids within the 2 weeks prior to study entry",
                    "criterion": "steroid dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage increase",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who have brain metastasis as the only measurable lesion",
            "criterions": [
                {
                    "exact_snippets": "brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "only measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "only"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any unresolved toxicity Grade 2 or more according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, from previous anticancer therapy excluding neuropathy, alopecia and rash",
            "criterions": [
                {
                    "exact_snippets": "Any unresolved toxicity Grade 2 or more according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0",
                    "criterion": "unresolved toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding neuropathy, alopecia and rash",
                    "criterion": "toxicity type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "neuropathy",
                                "alopecia",
                                "rash"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe hypersensitivity reactions to monoclonal antibodies (Grade greater than or equal to [>=] 3 NCI-CTCAE v 5.0), any history of anaphylaxis, or uncontrolled asthma (i.e., 3 or more occurrences of partially controlled asthma)",
            "criterions": [
                {
                    "exact_snippets": "Severe hypersensitivity reactions to monoclonal antibodies (Grade greater than or equal to [>=] 3 NCI-CTCAE v 5.0)",
                    "criterion": "hypersensitivity reactions to monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "NCI-CTCAE v 5.0"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any history of anaphylaxis",
                    "criterion": "history of anaphylaxis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled asthma (i.e., 3 or more occurrences of partially controlled asthma)",
                    "criterion": "uncontrolled asthma",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "occurrences of partially controlled asthma"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Discontinuation of the most recent cetuximab or panitumumab containing therapy due to an adverse event",
            "criterions": [
                {
                    "exact_snippets": "Discontinuation of the most recent cetuximab or panitumumab containing therapy due to an adverse event",
                    "criterion": "discontinuation of cetuximab or panitumumab therapy",
                    "requirements": [
                        {
                            "requirement_type": "reason",
                            "expected_value": "adverse event"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with other agents targeting the hepatocyte growth factor (HGF)/Mesenchymal epithelial transition (MET) pathway",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with other agents targeting the hepatocyte growth factor (HGF)/Mesenchymal epithelial transition (MET) pathway",
                    "criterion": "prior treatment with agents targeting HGF/MET pathway",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Impaired cardiac function: Left ventricular ejection fraction less than [<] 45 percent [%] defined by echocardiography (a screening assessment not required for participants without a history of congestive heart failure unless clinically indicated); Serious arrhythmia; Unstable angina pectoris; New York Heart Association heart failure Class III and IV; Myocardial infarction within the last 12 months prior to study entry and Symptomatic pericardial effusion; Corrected QT interval by Fridericia (QTcF) greater than (>) 480 milliseconds (ms)",
            "criterions": [
                {
                    "exact_snippets": "Impaired cardiac function: Left ventricular ejection fraction less than [<] 45 percent [%]",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association heart failure Class III and IV",
                    "criterion": "New York Heart Association heart failure class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Myocardial infarction within the last 12 months prior to study entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptomatic pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Corrected QT interval by Fridericia (QTcF) greater than (>) 480 milliseconds (ms)",
                    "criterion": "corrected QT interval by Fridericia (QTcF)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypertension uncontrolled by standard therapies (not stabilized to less than [< ]150/90 millimeter of mercury [mmHg])",
            "criterions": [
                {
                    "exact_snippets": "Hypertension uncontrolled by standard therapies",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not stabilized to less than [< ]150/90 millimeter of mercury [mmHg]",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "stabilization",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": "<",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of neoplasm other than mCRC",
            "criterions": [
                {
                    "exact_snippets": "History of neoplasm other than mCRC",
                    "criterion": "neoplasm history",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than mCRC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the test products",
            "criterions": [
                {
                    "exact_snippets": "History of difficulty swallowing",
                    "criterion": "difficulty swallowing",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption",
                    "criterion": "malabsorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic gastrointestinal disease",
                    "criterion": "chronic gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "conditions that may hamper compliance and/or absorption of the test products",
                    "criterion": "conditions that may hamper compliance and/or absorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 28 days prior to Day 1 of study intervention",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 28 days prior to Day 1 of study intervention",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of Interstitial lung disease (ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment",
            "criterions": [
                {
                    "exact_snippets": "History of Interstitial lung disease (ILD)",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "interstitial pneumonitis",
                    "criterion": "interstitial pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation pneumonitis that required steroid treatment",
                    "criterion": "radiation pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroid treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other protocol defined exclusion criteria could apply",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined exclusion criteria",
                    "criterion": "protocol defined exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Adequate hematological function, hepatic and renal functions as defined in the protocol",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematological function",
                    "criterion": "hematological function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as defined in the protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic ... functions",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as defined in the protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal functions",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as defined in the protocol"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for anti-cancer purposes, targeted therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to the first dose of study intervention, except for the anti-EGFR containing regimen including associated chemotherapy if applicable, which may be continued until enrollment of the participant in the study",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy ... within 21 days prior to the first dose of study intervention",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior biological therapy ... within 21 days prior to the first dose of study intervention",
                    "criterion": "prior biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior radiation therapy ... within 21 days prior to the first dose of study intervention",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior hormonal therapy for anti-cancer purposes ... within 21 days prior to the first dose of study intervention",
                    "criterion": "prior hormonal therapy for anti-cancer purposes",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior targeted therapy ... within 21 days prior to the first dose of study intervention",
                    "criterion": "prior targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior other investigational anticancer therapy ... within 21 days prior to the first dose of study intervention",
                    "criterion": "prior other investigational anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "palliative radiotherapy at focal sites",
                    "criterion": "palliative radiotherapy at focal sites",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-EGFR containing regimen including associated chemotherapy if applicable, which may be continued until enrollment of the participant in the study",
                    "criterion": "anti-EGFR containing regimen",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C virus",
            "criterions": [
                {
                    "exact_snippets": "Known infection with human immunodeficiency virus",
                    "criterion": "human immunodeficiency virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection with hepatitis B",
                    "criterion": "hepatitis B virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection with hepatitis C virus",
                    "criterion": "hepatitis C virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}