{
    "info": {
        "nct_id": "NCT03166631",
        "official_title": "An Open-label Phase I Dose Finding Trial With BI 891065 Alone and in Combination With BI 754091 to Characterise Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients With Advanced and/or Metastatic Malignancies",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria:\n\n* Provision of signed and dated, written informed consent form (ICF) in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses\n* Patients ≥18 years-of-age at the time of signature of the ICF\n* Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control (that result in a low failure rate of less than 1% per year when used consistently and correctly)during trial participation and for at least 6 months after the last administration of trial medication. A list of contraception methods meeting these criteria is provided in the patient information.\n* Eastern Cooperative Oncology Group (ECOG) score: 0 or 1\n* Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement\n* For Parts A and B: Patients with a confirmed diagnosis of advanced, unresectable and/or metastatic solid tumours, who have failed standard treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies. Measurable lesions according to RECIST Version 1.1 must be present. Eligibility is limited to the following tumour subtypes in Part B: bladder, colon, breast, Non-small cell lung cancer (NSCLC), ovarian, pancreatic, renal, esophagogastric, sarcoma, prostate, and melanoma.\n* For Parts B and C: Patients must have measurable disease per RECIST v1.1, must have at least 1 tumour lesion amenable to biopsy, and must be willing to undergo a biopsy prior to first treatment and another biopsy while on therapy unless clinically contraindicated.\n* For Part C: Patients with metastatic NSCLC who developed disease progression (per RECIST v1.1) after the first scan (where SD, Partial Response (PR), or Complete Response (CR) was demonstrated at the first scan), and require new anti-cancer therapy after first line treatment with an anti programmed cell death protein 1 (PD-1)/anti programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) (given either as single agent therapy or in combination with a platinum-based chemotherapy regimen).\n\nExclusion criteria:\n\n* Major surgery (major according to the Investigator's and/or Medical Monitor's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement)\n* Presence of other active invasive cancers other than the one treated in this trial within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumours considered cured by local treatment\n* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial\n* Previous administration of BI 891065 or BI 754091\n* Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatments.\n* Patients who have been treated with any other anticancer drug within 4 weeks or within 5 half-life periods (whichever come earlier) prior to first administration of BI 891065. At least 7 days must have elapsed between the last dose of such agent and the first dose of study drug.\n* Persistent toxicity from previous treatments that has not resolved to ≤ Grade 1 (except for alopecia and Grade 2 neuropathy due to prior platinum-based therapy)\n* Active, known or suspected autoimmune disease except vitiligo or resolved asthma/atopy\n* Interstitial lung disease\n* Any of the following cardiac criteria:\n\n  * Mean resting corrected QT interval (QTcF) >470 msec\n  * Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting Electrocardiograms (ECGs), e.g., complete left bundle branch block, third degree heart block\n  * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication with known or possible risk of QT interval prolongation\n  * Patients with an ejection fraction (EF) <55% or the lower limit of normal of the institutional standard will be excluded. Only in cases where the Investigator (or the treating physician or both) suspects cardiac disease with negative effect on the EF, will the EF be measured during screening using an appropriate method according to local standards to confirm eligibility (e.g., echocardiogram [ECHO], multi-gated acquisition scan [MUGA]). A historic measurement of EF no older than 6 months prior to first administration of study drug can be accepted provided that there is clinical evidence that the EF value has not worsened since this measurement in the opinion of the Investigator or of the treating physician or both.\n* Out of range laboratory values are defined as:\n\n  * Alanine transaminase (ALT) and aspartate amino transferase (AST) >3 times the Upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases\n  * Total bilirubin >1.5 times ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 times ULN or direct bilirubin >1.5 times ULN\n* Human immunodeficiency virus (HIV) infection, acute or chronic viral hepatitis\n* Known hypersensitivity to the trial drugs or their excipients\n* Serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as cardiac, neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the Investigator and/or Medical Monitor would make the patient inappropriate for entry into the trial.\n* Chronic alcohol or drug abuse or any condition that, in the Investigator's and/or Medical Monitor's opinion, makes them an unreliable trial patient or unlikely to complete the trial\n* Women who are pregnant, nursing, or who plan to become pregnant while in the trial and for at least 6 months after the last administration of trial medication.\n* Men who plan to father a child while in the trial and for at least 6 months after the last administration of trial medication.\n* Known presence of symptomatic central nervous system (CNS) metastases, unless asymptomatic and off corticosteroids and/or anti-convulsant therapy for at least 2 weeks prior start of treatment. Patients with asymptomatic CNS metastases may be enrolled following a 2-week washout period.\n* Patients receiving systemic treatment with any immunosuppressive medication within 1 week prior treatment start (steroids of max. 10 mg prednisolone equivalent per day are allowed, topical and inhaled steroids are not considered as immunosuppressive).\n* For Parts A and B: Patients with known epidermal growth factor receptor (EGFR), known anaplastic lymphoma kinase (ALK), or known ROS Proto-Oncogene 1 (ROS1) genomic tumour aberrations, unless disease has progressed following available EGFR or ALK targeted therapy (including osimertinib for EGFR T790M-mutated NSCLC)\n* Out of range lab values as defined:\n\n  * Absolute neutrophil count (ANC) <1.5 x 109/L (<1500/mm3)\n  * Platelet (PLT) count <100 x 109/L\n* Haemoglobin <90 g/L (<9 g/dL)\n\n  -- Creatinine >1.5 times ULN (patients may enter if creatinine is >1.5 x ULN and estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2) (Chronic Kidney Disease Epidemiology [CKD-EPI] Collaboration equation); confirmation of eGRF is only required when creatinine is >1.5 X ULN.\n* For Part C: Patients with EGFR, ALK, or (if known) ROS1 genomic tumor aberrations\n* For Part C: Patients with any CTLA-4 therapy\n* For Part C: One or more lines of anti-cancer therapy between previous anti-PD-1/anti-PDL1 mAb therapy and study entry."
    },
    "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": "* Provision of signed and dated, written informed consent form (ICF) in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses",
            "criterions": [
                {
                    "exact_snippets": "Provision of signed and dated, written informed consent form (ICF)",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dated",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation",
                    "criterion": "compliance with ICH-GCP and local legislation",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients ≥18 years-of-age at the time of signature of the ICF",
            "criterions": [
                {
                    "exact_snippets": "Patients ≥18 years-of-age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control (that result in a low failure rate of less than 1% per year when used consistently and correctly)during trial participation and for at least 6 months after the last administration of trial medication. A list of contraception methods meeting these criteria is provided in the patient information.",
            "criterions": [
                {
                    "exact_snippets": "Male or female patients.",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential (WOCBP) ... must be ready and able to use highly effective methods of birth control ... during trial participation and for at least 6 months after the last administration of trial medication.",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "birth control readiness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men able to father a child must be ready and able to use highly effective methods of birth control ... during trial participation and for at least 6 months after the last administration of trial medication.",
                    "criterion": "men able to father a child",
                    "requirements": [
                        {
                            "requirement_type": "birth control readiness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) score: 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score: 0 or 1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Parts A and B: Patients with a confirmed diagnosis of advanced, unresectable and/or metastatic solid tumours, who have failed standard treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies. Measurable lesions according to RECIST Version 1.1 must be present. Eligibility is limited to the following tumour subtypes in Part B: bladder, colon, breast, Non-small cell lung cancer (NSCLC), ovarian, pancreatic, renal, esophagogastric, sarcoma, prostate, and melanoma.",
            "criterions": [
                {
                    "exact_snippets": "confirmed diagnosis of advanced, unresectable and/or metastatic solid tumours",
                    "criterion": "solid tumours",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "confirmed"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "who have failed standard treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failed"
                        },
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable lesions according to RECIST Version 1.1 must be present",
                    "criterion": "measurable lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST Version 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Eligibility is limited to the following tumour subtypes in Part B: bladder, colon, breast, Non-small cell lung cancer (NSCLC), ovarian, pancreatic, renal, esophagogastric, sarcoma, prostate, and melanoma",
                    "criterion": "tumour subtypes",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": [
                                "bladder",
                                "colon",
                                "breast",
                                "Non-small cell lung cancer (NSCLC)",
                                "ovarian",
                                "pancreatic",
                                "renal",
                                "esophagogastric",
                                "sarcoma",
                                "prostate",
                                "melanoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Parts B and C: Patients must have measurable disease per RECIST v1.1, must have at least 1 tumour lesion amenable to biopsy, and must be willing to undergo a biopsy prior to first treatment and another biopsy while on therapy unless clinically contraindicated.",
            "criterions": [
                {
                    "exact_snippets": "measurable disease per RECIST v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 1 tumour lesion amenable to biopsy",
                    "criterion": "tumour lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "amenability to biopsy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to undergo a biopsy prior to first treatment",
                    "criterion": "willingness to undergo biopsy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to first treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to undergo ... another biopsy while on therapy unless clinically contraindicated",
                    "criterion": "willingness to undergo biopsy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "while on therapy"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "unless clinically contraindicated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Part C: Patients with metastatic NSCLC who developed disease progression (per RECIST v1.1) after the first scan (where SD, Partial Response (PR), or Complete Response (CR) was demonstrated at the first scan), and require new anti-cancer therapy after first line treatment with an anti programmed cell death protein 1 (PD-1)/anti programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) (given either as single agent therapy or in combination with a platinum-based chemotherapy regimen).",
            "criterions": [
                {
                    "exact_snippets": "metastatic NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "metastatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progression (per RECIST v1.1)",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "SD, Partial Response (PR), or Complete Response (CR) was demonstrated at the first scan",
                    "criterion": "response at first scan",
                    "requirements": [
                        {
                            "requirement_type": "response type",
                            "expected_value": [
                                "SD",
                                "PR",
                                "CR"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "require new anti-cancer therapy after first line treatment",
                    "criterion": "need for new anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after first line treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "first line treatment with an anti programmed cell death protein 1 (PD-1)/anti programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb)",
                    "criterion": "first line treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "anti PD-1/PD-L1 mAb"
                        }
                    ]
                },
                {
                    "exact_snippets": "given either as single agent therapy or in combination with a platinum-based chemotherapy regimen",
                    "criterion": "treatment regimen",
                    "requirements": [
                        {
                            "requirement_type": "combination",
                            "expected_value": [
                                "single agent",
                                "platinum-based chemotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery (major according to the Investigator's and/or Medical Monitor's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement)",
            "criterions": [
                {
                    "exact_snippets": "Major surgery (major according to the Investigator's and/or Medical Monitor's assessment) performed within 12 weeks prior to randomization",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "Major surgery (major according to the Investigator's and/or Medical Monitor's assessment) ... planned within 12 months after screening",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "after screening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of other active invasive cancers other than the one treated in this trial within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumours considered cured by local treatment",
            "criterions": [
                {
                    "exact_snippets": "Presence of other active invasive cancers other than the one treated in this trial within 5 years prior to screening",
                    "criterion": "other active invasive cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except appropriately treated basal cell carcinoma of the skin",
                    "criterion": "appropriately treated basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... in situ carcinoma of uterine cervix",
                    "criterion": "in situ carcinoma of uterine cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... other local tumours considered cured by local treatment",
                    "criterion": "other local tumours considered cured by local treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial",
            "criterions": [
                {
                    "exact_snippets": "must or wish to continue the intake of restricted medications",
                    "criterion": "intake of restricted medications",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any drug considered likely to interfere with the safe conduct of the trial",
                    "criterion": "drug interference with trial",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "likely"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous administration of BI 891065 or BI 754091",
            "criterions": [
                {
                    "exact_snippets": "Previous administration of BI 891065",
                    "criterion": "administration of BI 891065",
                    "requirements": [
                        {
                            "requirement_type": "previous administration",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous administration of ... BI 754091",
                    "criterion": "administration of BI 754091",
                    "requirements": [
                        {
                            "requirement_type": "previous administration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatments.",
            "criterions": [
                {
                    "exact_snippets": "Currently enrolled in another investigational device or drug trial",
                    "criterion": "enrollment in another investigational trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "less than 30 days since ending another investigational device or drug trial(s)",
                    "criterion": "time since ending another investigational trial",
                    "requirements": [
                        {
                            "requirement_type": "time since ending",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving other investigational treatments",
                    "criterion": "receiving other investigational treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have been treated with any other anticancer drug within 4 weeks or within 5 half-life periods (whichever come earlier) prior to first administration of BI 891065. At least 7 days must have elapsed between the last dose of such agent and the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "treated with any other anticancer drug within 4 weeks or within 5 half-life periods (whichever come earlier) prior to first administration of BI 891065",
                    "criterion": "prior anticancer drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-life periods"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 7 days must have elapsed between the last dose of such agent and the first dose of study drug",
                    "criterion": "time elapsed since last anticancer drug dose",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persistent toxicity from previous treatments that has not resolved to ≤ Grade 1 (except for alopecia and Grade 2 neuropathy due to prior platinum-based therapy)",
            "criterions": [
                {
                    "exact_snippets": "Persistent toxicity from previous treatments",
                    "criterion": "toxicity from previous treatments",
                    "requirements": [
                        {
                            "requirement_type": "persistence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "toxicity ... has not resolved to ≤ Grade 1",
                    "criterion": "toxicity resolution",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Grade 2 neuropathy due to prior platinum-based therapy",
                    "criterion": "neuropathy due to prior platinum-based therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active, known or suspected autoimmune disease except vitiligo or resolved asthma/atopy",
            "criterions": [
                {
                    "exact_snippets": "Active, known or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "known",
                                "suspected"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "except vitiligo",
                    "criterion": "vitiligo",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... resolved asthma/atopy",
                    "criterion": "resolved asthma/atopy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "resolved"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "Interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any of the following cardiac criteria:",
            "criterions": [
                {
                    "exact_snippets": "Any of the following cardiac criteria",
                    "criterion": "cardiac criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mean resting corrected QT interval (QTcF) >470 msec",
            "criterions": [
                {
                    "exact_snippets": "Mean resting corrected QT interval (QTcF) >470 msec",
                    "criterion": "corrected QT interval (QTcF)",
                    "requirements": [
                        {
                            "requirement_type": "mean value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting Electrocardiograms (ECGs), e.g., complete left bundle branch block, third degree heart block",
            "criterions": [
                {
                    "exact_snippets": "clinically important abnormalities ... in rhythm ... of resting Electrocardiograms (ECGs)",
                    "criterion": "ECG rhythm",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically important abnormalities ... in ... conduction ... of resting Electrocardiograms (ECGs)",
                    "criterion": "ECG conduction",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically important abnormalities ... in ... morphology of resting Electrocardiograms (ECGs)",
                    "criterion": "ECG morphology",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication with known or possible risk of QT interval prolongation",
            "criterions": [
                {
                    "exact_snippets": "factors that increase the risk of QTc prolongation or risk of arrhythmic events",
                    "criterion": "risk factors for QTc prolongation or arrhythmic events",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypokalaemia",
                    "criterion": "hypokalaemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "family history of long QT syndrome",
                    "criterion": "family history of long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unexplained sudden death under 40 years-of-age",
                    "criterion": "unexplained sudden death under 40 years-of-age",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "concomitant medication with known or possible risk of QT interval prolongation",
                    "criterion": "concomitant medication with risk of QT interval prolongation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with an ejection fraction (EF) <55% or the lower limit of normal of the institutional standard will be excluded. Only in cases where the Investigator (or the treating physician or both) suspects cardiac disease with negative effect on the EF, will the EF be measured during screening using an appropriate method according to local standards to confirm eligibility (e.g., echocardiogram [ECHO], multi-gated acquisition scan [MUGA]). A historic measurement of EF no older than 6 months prior to first administration of study drug can be accepted provided that there is clinical evidence that the EF value has not worsened since this measurement in the opinion of the Investigator or of the treating physician or both.",
            "criterions": [
                {
                    "exact_snippets": "ejection fraction (EF) <55% or the lower limit of normal of the institutional standard",
                    "criterion": "ejection fraction (EF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 55,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 1,
                                        "unit": "institutional standard"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac disease with negative effect on the EF",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "effect on EF",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "historic measurement of EF no older than 6 months prior to first administration of study drug",
                    "criterion": "historic measurement of EF",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical evidence that the EF value has not worsened since this measurement",
                    "criterion": "EF value",
                    "requirements": [
                        {
                            "requirement_type": "change since last measurement",
                            "expected_value": "not worsened"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Out of range laboratory values are defined as:",
            "criterions": [
                {
                    "exact_snippets": "Out of range laboratory values",
                    "criterion": "laboratory values",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "out of range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alanine transaminase (ALT) and aspartate amino transferase (AST) >3 times the Upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases",
            "criterions": [
                {
                    "exact_snippets": "Alanine transaminase (ALT) ... >3 times the Upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases",
                    "criterion": "Alanine transaminase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 3,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "no demonstrable liver metastases"
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine transaminase (ALT) ... >5 times ULN in the presence of liver metastases",
                    "criterion": "Alanine transaminase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "presence of liver metastases"
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate amino transferase (AST) >3 times the Upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases",
                    "criterion": "aspartate amino transferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 3,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "no demonstrable liver metastases"
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate amino transferase (AST) ... >5 times ULN in the presence of liver metastases",
                    "criterion": "aspartate amino transferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "presence of liver metastases"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin >1.5 times ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 times ULN or direct bilirubin >1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin >1.5 times ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilbert's syndrome ... total bilirubin >3.0 times ULN",
                    "criterion": "total bilirubin in patients with Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilbert's syndrome ... direct bilirubin >1.5 times ULN",
                    "criterion": "direct bilirubin in patients with Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human immunodeficiency virus (HIV) infection, acute or chronic viral hepatitis",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acute or chronic viral hepatitis",
                    "criterion": "viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "chronicity",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to the trial drugs or their excipients",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to the trial drugs or their excipients",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as cardiac, neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the Investigator and/or Medical Monitor would make the patient inappropriate for entry into the trial.",
            "criterions": [
                {
                    "exact_snippets": "Serious concomitant disease or medical condition affecting compliance with trial requirements",
                    "criterion": "serious concomitant disease or medical condition",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "affecting compliance with trial requirements"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac, neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin)",
                    "criterion": "specific medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "cardiac disease",
                                "neurologic disease",
                                "psychiatric disease",
                                "infectious disease",
                                "active ulcers (gastro-intestinal tract)",
                                "active ulcers (skin)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality that may increase the risk associated with trial participation or trial drug administration",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "risk increase",
                            "expected_value": "may increase the risk associated with trial participation or trial drug administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "in the judgment of the Investigator and/or Medical Monitor would make the patient inappropriate for entry into the trial",
                    "criterion": "investigator/medical monitor judgment",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness for trial entry",
                            "expected_value": "inappropriate for entry into the trial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic alcohol or drug abuse or any condition that, in the Investigator's and/or Medical Monitor's opinion, makes them an unreliable trial patient or unlikely to complete the trial",
            "criterions": [
                {
                    "exact_snippets": "Chronic alcohol or drug abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any condition that, in the Investigator's and/or Medical Monitor's opinion, makes them an unreliable trial patient or unlikely to complete the trial",
                    "criterion": "reliability as a trial patient",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "Investigator's and/or Medical Monitor's opinion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who are pregnant, nursing, or who plan to become pregnant while in the trial and for at least 6 months after the last administration of trial medication.",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "plan to become pregnant while in the trial and for at least 6 months after the last administration of trial medication",
                    "criterion": "plan to become pregnant",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "while in the trial and for at least 6 months after the last administration of trial medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men who plan to father a child while in the trial and for at least 6 months after the last administration of trial medication.",
            "criterions": [
                {
                    "exact_snippets": "Men who plan to father a child",
                    "criterion": "plan to father a child",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "while in the trial and for at least 6 months after the last administration of trial medication",
                    "criterion": "timeframe for fathering a child",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "while in the trial and for at least 6 months after the last administration of trial medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known presence of symptomatic central nervous system (CNS) metastases, unless asymptomatic and off corticosteroids and/or anti-convulsant therapy for at least 2 weeks prior start of treatment. Patients with asymptomatic CNS metastases may be enrolled following a 2-week washout period.",
            "criterions": [
                {
                    "exact_snippets": "Known presence of symptomatic central nervous system (CNS) metastases",
                    "criterion": "symptomatic CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless asymptomatic and off corticosteroids and/or anti-convulsant therapy for at least 2 weeks prior start of treatment",
                    "criterion": "asymptomatic CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "corticosteroid therapy",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "anti-convulsant therapy",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "duration off therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving systemic treatment with any immunosuppressive medication within 1 week prior treatment start (steroids of max. 10 mg prednisolone equivalent per day are allowed, topical and inhaled steroids are not considered as immunosuppressive).",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving systemic treatment with any immunosuppressive medication within 1 week prior treatment start",
                    "criterion": "systemic immunosuppressive medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "steroids of max. 10 mg prednisolone equivalent per day are allowed",
                    "criterion": "steroid dosage",
                    "requirements": [
                        {
                            "requirement_type": "maximum dosage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg prednisolone equivalent per day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "topical and inhaled steroids are not considered as immunosuppressive",
                    "criterion": "topical and inhaled steroids",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "not considered as immunosuppressive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Parts A and B: Patients with known epidermal growth factor receptor (EGFR), known anaplastic lymphoma kinase (ALK), or known ROS Proto-Oncogene 1 (ROS1) genomic tumour aberrations, unless disease has progressed following available EGFR or ALK targeted therapy (including osimertinib for EGFR T790M-mutated NSCLC)",
            "criterions": [
                {
                    "exact_snippets": "known epidermal growth factor receptor (EGFR) ... genomic tumour aberrations",
                    "criterion": "EGFR genomic tumour aberrations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known anaplastic lymphoma kinase (ALK) ... genomic tumour aberrations",
                    "criterion": "ALK genomic tumour aberrations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known ROS Proto-Oncogene 1 (ROS1) genomic tumour aberrations",
                    "criterion": "ROS1 genomic tumour aberrations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless disease has progressed following available EGFR or ALK targeted therapy",
                    "criterion": "disease progression after targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including osimertinib for EGFR T790M-mutated NSCLC",
                    "criterion": "osimertinib for EGFR T790M-mutated NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "osimertinib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Out of range lab values as defined:",
            "criterions": [
                {
                    "exact_snippets": "Out of range lab values",
                    "criterion": "lab values",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "out of range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) <1.5 x 109/L (<1500/mm3)",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) <1.5 x 109/L (<1500/mm3)",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet (PLT) count <100 x 109/L",
            "criterions": [
                {
                    "exact_snippets": "Platelet (PLT) count <100 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Haemoglobin <90 g/L (<9 g/dL)",
            "criterions": [
                {
                    "exact_snippets": "Haemoglobin <90 g/L (<9 g/dL)",
                    "criterion": "haemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "g/L"
                            }
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "-- Creatinine >1.5 times ULN (patients may enter if creatinine is >1.5 x ULN and estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2) (Chronic Kidney Disease Epidemiology [CKD-EPI] Collaboration equation); confirmation of eGRF is only required when creatinine is >1.5 X ULN.",
            "criterions": [
                {
                    "exact_snippets": "Creatinine >1.5 times ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2",
                    "criterion": "estimated glomerular filtration rate (eGFR)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "mL/min/1.73 m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Part C: Patients with EGFR, ALK, or (if known) ROS1 genomic tumor aberrations",
            "criterions": [
                {
                    "exact_snippets": "EGFR",
                    "criterion": "EGFR genomic tumor aberrations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ALK",
                    "criterion": "ALK genomic tumor aberrations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ROS1 genomic tumor aberrations",
                    "criterion": "ROS1 genomic tumor aberrations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Part C: Patients with any CTLA-4 therapy",
            "criterions": [
                {
                    "exact_snippets": "Patients with any CTLA-4 therapy",
                    "criterion": "CTLA-4 therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Part C: One or more lines of anti-cancer therapy between previous anti-PD-1/anti-PDL1 mAb therapy and study entry.",
            "criterions": [
                {
                    "exact_snippets": "One or more lines of anti-cancer therapy between previous anti-PD-1/anti-PDL1 mAb therapy and study entry.",
                    "criterion": "lines of anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria:",
            "criterions": []
        },
        {
            "line": "Exclusion criteria:",
            "criterions": []
        }
    ]
}