{
    "info": {
        "nct_id": "NCT02818920",
        "official_title": "Pembrolizumab Prior to Surgery for Stage 1B, 2 or 3A Non-small Cell Lung Cancer (NSCLC): A Phase II Study",
        "inclusion_criteria": "* Histologically or cytologically confirmed NSCLC.\n* Clinical stage IB (>/= 3 cm per CT), Stage IIA/IIB, or Stage IIIA (N0-2) amenable to surgical resection.\n* Primary tumor >/= 3 cm (for all stages entered) to make it likely that excess tumor will be available after resection.\n* Patient must be deemed a surgical candidate.\n* ECOG performance status of 0 or 1 (Appendix C).\n* No prior chemotherapy, radiation therapy or biologic/targeted therapy for current diagnosis of lung cancer.\n* Adequate Organ Function\n* Age ≥18 years.\n* Non-pregnant. Females of child-bearing potential (not surgically sterilized or postmenopausal [a woman who is > 45 years of age and has not had menses for greater than 1 year]) must test negative for pregnancy within 48 hours prior to any initial study procedure based on a serum pregnancy test.\n* No active invasive malignancy in the past 2 years other than non-melanoma skin cancer. Cancers that are in-situ are not considered invasive.\n* Signed written informed consent including HIPAA according to institutional guidelines.\n* Patients must agree to research blood sampling to participate in study.\n* Have measurable disease based on RECIST 1.1.\n* Post-op predicted FEV1 and DLCO > 40% predicted (or per institutional standard).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry or used an investigational device within 4 weeks of the first dose of treatment.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Hypersensitivity to pembrolizumab or any of its excipients.\n* Concurrent administration of any other anti-tumor therapy.\n* Has received prior therapy with an anti-PD-1, anti-PD-L-1, or anti-PD-L2 agent.\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).\n* Inability to comply with protocol or study procedures.\n* Active infection requiring antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.\n* Has known history of, or any evidence of active, non-infectious pneumonitis.\n* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency etc) is not considered a form of systemic treatment. Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Has a known additional invasive malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Has had major surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant disorders that in the opinion of the investigator would compromise the safety of the patient or compromise the patient's ability to complete the study.\n* Has received any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 30 days before or after any dose of pembrolizumab). Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.\n* Has history of myocardial infarction having occurred less than 6 months before inclusion, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications. Patients with CAD recently treated with surgery and/or stent, if stable without symptomatic angina pectoris, active ischemia are eligible.\n* Has a history of interstitial lung disease\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Prisoners or subjects who are compulsorily detained involuntarily incarcerated) for treatment of either psychiatric or physical (e.g., infectious) illness.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed NSCLC.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical stage IB (>/= 3 cm per CT), Stage IIA/IIB, or Stage IIIA (N0-2) amenable to surgical resection.",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage IB (>/= 3 cm per CT)",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IB"
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage IIA/IIB",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIA",
                                "IIB"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage IIIA (N0-2)",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IIIA"
                        },
                        {
                            "requirement_type": "nodal involvement",
                            "expected_value": "N0-2"
                        }
                    ]
                },
                {
                    "exact_snippets": "amenable to surgical resection",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary tumor >/= 3 cm (for all stages entered) to make it likely that excess tumor will be available after resection.",
            "criterions": [
                {
                    "exact_snippets": "Primary tumor >/= 3 cm",
                    "criterion": "primary tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be deemed a surgical candidate.",
            "criterions": [
                {
                    "exact_snippets": "Patient must be deemed a surgical candidate.",
                    "criterion": "surgical candidacy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "candidate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0 or 1 (Appendix C).",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy, radiation therapy or biologic/targeted therapy for current diagnosis of lung cancer.",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy ... for current diagnosis of lung cancer.",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... radiation therapy ... for current diagnosis of lung cancer.",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... biologic/targeted therapy for current diagnosis of lung cancer.",
                    "criterion": "prior biologic/targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate Organ Function",
            "criterions": [
                {
                    "exact_snippets": "Adequate Organ Function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-pregnant. Females of child-bearing potential (not surgically sterilized or postmenopausal [a woman who is > 45 years of age and has not had menses for greater than 1 year]) must test negative for pregnancy within 48 hours prior to any initial study procedure based on a serum pregnancy test.",
            "criterions": [
                {
                    "exact_snippets": "Non-pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Females of child-bearing potential (not surgically sterilized or postmenopausal",
                    "criterion": "female child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "postmenopausal [a woman who is > 45 years of age and has not had menses for greater than 1 year]",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 45,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "menses absence duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must test negative for pregnancy within 48 hours prior to any initial study procedure based on a serum pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 48 hours prior to any initial study procedure",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 48 hours prior to any initial study procedure"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active invasive malignancy in the past 2 years other than non-melanoma skin cancer. Cancers that are in-situ are not considered invasive.",
            "criterions": [
                {
                    "exact_snippets": "No active invasive malignancy in the past 2 years",
                    "criterion": "active invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other than non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Cancers that are in-situ are not considered invasive",
                    "criterion": "in-situ cancers",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "not invasive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed written informed consent including HIPAA according to institutional guidelines.",
            "criterions": [
                {
                    "exact_snippets": "Signed written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "format",
                            "expected_value": "written"
                        }
                    ]
                },
                {
                    "exact_snippets": "HIPAA according to institutional guidelines",
                    "criterion": "HIPAA compliance",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": "institutional guidelines"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must agree to research blood sampling to participate in study.",
            "criterions": [
                {
                    "exact_snippets": "Patients must agree to research blood sampling",
                    "criterion": "research blood sampling",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have measurable disease based on RECIST 1.1.",
            "criterions": [
                {
                    "exact_snippets": "measurable disease based on RECIST 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Post-op predicted FEV1 and DLCO > 40% predicted (or per institutional standard).",
            "criterions": [
                {
                    "exact_snippets": "Post-op predicted FEV1 ... > 40% predicted",
                    "criterion": "post-op predicted FEV1",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "% predicted"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Post-op predicted ... DLCO > 40% predicted",
                    "criterion": "post-op predicted DLCO",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "% predicted"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry or used an investigational device within 4 weeks of the first dose of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Treatment within the last 30 days with a drug that has not received regulatory approval for any indication",
                    "criterion": "treatment with unapproved drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        },
                        {
                            "requirement_type": "approval status",
                            "expected_value": "not received regulatory approval"
                        }
                    ]
                },
                {
                    "exact_snippets": "used an investigational device within 4 weeks of the first dose of treatment",
                    "criterion": "use of investigational device",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known history of active TB (Bacillus Tuberculosis).",
            "criterions": [
                {
                    "exact_snippets": "known history of active TB (Bacillus Tuberculosis)",
                    "criterion": "active TB (Bacillus Tuberculosis)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity to pembrolizumab or any of its excipients.",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to pembrolizumab",
                    "criterion": "hypersensitivity to pembrolizumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... any of its excipients",
                    "criterion": "hypersensitivity to pembrolizumab excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent administration of any other anti-tumor therapy.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent administration of any other anti-tumor therapy.",
                    "criterion": "anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent administration",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received prior therapy with an anti-PD-1, anti-PD-L-1, or anti-PD-L2 agent.",
            "criterions": [
                {
                    "exact_snippets": "Has received prior therapy with an anti-PD-1",
                    "criterion": "prior therapy with anti-PD-1 agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... anti-PD-L-1",
                    "criterion": "prior therapy with anti-PD-L-1 agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... anti-PD-L2 agent",
                    "criterion": "prior therapy with anti-PD-L2 agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).",
            "criterions": [
                {
                    "exact_snippets": "Has known active Hepatitis B (e.g., HBsAg reactive)",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Has known active ... Hepatitis C (e.g., HCV RNA [qualitative] is detected)",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to comply with protocol or study procedures.",
            "criterions": [
                {
                    "exact_snippets": "Inability to comply with protocol or study procedures.",
                    "criterion": "compliance with protocol or study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection requiring antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring antibiotics, antifungal or antiviral agents",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": [
                                "antibiotics",
                                "antifungal",
                                "antiviral"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in the opinion of the investigator would compromise the patient's ability to tolerate therapy",
                    "criterion": "ability to tolerate therapy",
                    "requirements": [
                        {
                            "requirement_type": "compromise risk",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known history of, or any evidence of active, non-infectious pneumonitis.",
            "criterions": [
                {
                    "exact_snippets": "known history of, or any evidence of active, non-infectious pneumonitis",
                    "criterion": "non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "evidence of activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).",
            "criterions": [
                {
                    "exact_snippets": "known history of Human Immunodeficiency Virus (HIV)",
                    "criterion": "Human Immunodeficiency Virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency etc) is not considered a form of systemic treatment. Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).",
            "criterions": [
                {
                    "exact_snippets": "active autoimmune disease that has required systemic treatment in the past 2 years",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis])",
                    "criterion": "symptomatic autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis)",
                    "criterion": "autoimmune motor neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "Has a diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving ... any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 7 days prior to the first dose of trial treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known additional invasive malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.",
            "criterions": [
                {
                    "exact_snippets": "Has a known additional invasive malignancy that is progressing or requires active treatment.",
                    "criterion": "additional invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "active treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "curative therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                    "criterion": "squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "curative therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions include ... in situ cervical cancer.",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "Is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expecting to conceive",
                    "criterion": "expecting to conceive",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "father children",
                    "criterion": "expecting to father children",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has had major surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant disorders that in the opinion of the investigator would compromise the safety of the patient or compromise the patient's ability to complete the study.",
            "criterions": [
                {
                    "exact_snippets": "Has had major surgery (other than definitive lung cancer surgery) within two weeks of study",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other serious concomitant disorders that in the opinion of the investigator would compromise the safety of the patient",
                    "criterion": "serious concomitant disorders",
                    "requirements": [
                        {
                            "requirement_type": "impact on safety",
                            "expected_value": "compromise"
                        }
                    ]
                },
                {
                    "exact_snippets": "other serious concomitant disorders that in the opinion of the investigator would ... compromise the patient's ability to complete the study",
                    "criterion": "serious concomitant disorders",
                    "requirements": [
                        {
                            "requirement_type": "impact on study completion",
                            "expected_value": "compromise"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 30 days before or after any dose of pembrolizumab). Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.",
            "criterions": [
                {
                    "exact_snippets": "Has received any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 30 days before or after any dose of pembrolizumab)",
                    "criterion": "non-oncology vaccine therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "up to 30 days before or after any dose of pembrolizumab"
                        }
                    ]
                },
                {
                    "exact_snippets": "Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed",
                    "criterion": "seasonal influenza vaccines for injection",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed",
                    "criterion": "intranasal influenza vaccines",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has history of myocardial infarction having occurred less than 6 months before inclusion, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications. Patients with CAD recently treated with surgery and/or stent, if stable without symptomatic angina pectoris, active ischemia are eligible.",
            "criterions": [
                {
                    "exact_snippets": "history of myocardial infarction having occurred less than 6 months before inclusion",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any known uncontrolled arrhythmia",
                    "criterion": "uncontrolled arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic angina pectoris",
                    "criterion": "symptomatic angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active ischemia",
                    "criterion": "active ischemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac failure not controlled by medications",
                    "criterion": "cardiac failure",
                    "requirements": [
                        {
                            "requirement_type": "control by medications",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with CAD recently treated with surgery and/or stent, if stable without symptomatic angina pectoris, active ischemia are eligible",
                    "criterion": "CAD recently treated with surgery and/or stent",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptomatic angina pectoris",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "active ischemia",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a history of interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "Has a history of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",
            "criterions": [
                {
                    "exact_snippets": "known psychiatric ... interfere with cooperation",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "interference with trial cooperation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "substance abuse disorders ... interfere with cooperation",
                    "criterion": "substance abuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "interference with trial cooperation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prisoners or subjects who are compulsorily detained involuntarily incarcerated) for treatment of either psychiatric or physical (e.g., infectious) illness.",
            "criterions": [
                {
                    "exact_snippets": "Prisoners",
                    "criterion": "prisoner status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects who are compulsorily detained involuntarily incarcerated",
                    "criterion": "involuntary incarceration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment of either psychiatric ... illness",
                    "criterion": "treatment for psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment of either ... physical (e.g., infectious) illness",
                    "criterion": "treatment for physical illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}