{
"info": {
"nct_id": "NCT03818776",
"official_title": "A Pilot Trial of Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable Non-Small Cell Lung Cancer With Extended Durvalumab Therapy (PARTICLE-D)",
"inclusion_criteria": "* ECOG performance status 0-2\n* Body Weight >30kg\n* Must have anticipated life expectancy of at least 12 weeks\n* Must be histologically or cytologically confirmed to be non-small cell lung cancer (NSCLC) confirmed by biopsy within 90 days of registration.\n* Any tumor PD-L1 expression is allowed (including 0% to 100%, or unknown at time of study enrollment)\n* AJCC 8th Stage IIA-IIIC.\n* Must be deemed by Specialist or tumor board decision to not be a candidate for surgical resection or the participant refuses resection. Being deemed unresectable can be for any reason, including but not limited to: tumor location, tumor characteristics, operative risks, poor participant lung function, participant age or medical comorbidity.\n* Must be deemed by Medical Oncologist or tumor board decision to not be a candidate for or able to tolerate standard cisplatinum based doublet concurrent chemoradiation therapy or the participant refuses chemotherapy. Being deemed not a chemotherapy candidate can be for any reason, including but not limited to: age, medical comorbidity, end organ dysfunction.\n* Pulmonary function testing performed within 365 days prior to registration. . Sufficient lung function as judged by the primary investigator based on anticipated radiation fields, with a minimum of FEV1 ≥ 0.7 Liter or ≥ 30% and DLCO ≥ 30% with or without bronchodilator within 365 days prior to registration.\n* Adequate normal organ and marrow function as defined below:\n* Haemoglobin ≥9.0 g/dL\n* Absolute neutrophil count (ANC) 1.5 (or 1.0) x (> 1500 per mm3)\n* Platelet count ≥75 x 109/L (>75,000 per mm3)\n* Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to participants with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n* AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal\n* Measured creatinine clearance (CL) >30 mL/min or Calculated creatinine CL>30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n* Males:\n\nCreatinine CL (mL/min) = (Weight (kg) x (140 - Age)) / (72 x serum creatinine (mg/dL))\n\n* Females:\n\nCreatinine CL (mL/min) = (Weight (kg) x (140 - Age)) / (72 x serum creatinine (mg/dL)) x 0.85\n\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n* Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n* Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n* Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\nHealthy volunteers allowed\nMust have minimum age of 19 Years",
"exclusion_criteria": "* Prior large field thoracic radiation therapy is not allowed except for at the discretion of the primary investigator. Prior SBRT to contralateral lung, or breast radiation greater than 3 years prior is allowed. Other prior thoracic radiation is allowed at the discretion of the primary investigator.\n* Prior radiation therapy, or immunotherapy for current diagnosis of NSCLC\n* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n* Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n* History of another primary malignancy except for:\n* Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n* Adequately treated carcinoma in situ (i.e. breast) without evidence of disease\n* Low risk prostate cancer which has been treated or is undergoing active surveillance.\n* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n* Participants with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n* Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.\n* Judgment by the investigator that the participant is unsuitable to participate in the study and the participant is unlikely to comply with study procedures, restrictions and requirements\n\nMedication Specific Exclusion Criterion:\n\n* History of primary immunodeficiency\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:\n* Participants with vitiligo or alopecia\n* Participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n* Any chronic skin condition that does not require systemic therapy\n* Participants without active disease in the last 5 years may be included but only after consultation with the study physician\n* Participants with celiac disease controlled by diet alone\n* Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation\n* Treatment with systemic immunosuppressive medications (including but not limited to prednisone > 10 mg daily, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1. However, the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for participants with orthostatic hypotension or adrenocortical insufficiency is allowed.\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive human immunodeficiency virus [HIV] 1/2 antibodies). Participants with a past or resolved hepatitis B (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Participants, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n* Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
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"line": "* Must be deemed by Specialist or tumor board decision to not be a candidate for surgical resection or the participant refuses resection. Being deemed unresectable can be for any reason, including but not limited to: tumor location, tumor characteristics, operative risks, poor participant lung function, participant age or medical comorbidity.",
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{
"identified_line": {
"line": "* Females:",
"criterions": [
{
"exact_snippets": "Females",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Females",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Creatinine CL (mL/min) = (Weight (kg) x (140 - Age)) / (72 x serum creatinine (mg/dL)) x 0.85",
"criterions": [
{
"exact_snippets": "Creatinine CL (mL/min)",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "calculation",
"expected_value": "(Weight (kg) x (140 - Age)) / (72 x serum creatinine (mg/dL)) x 0.85"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Creatinine CL (mL/min)",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "calculation",
"expected_value": "(Weight (kg) x (140 - Age)) / (72 x serum creatinine (mg/dL)) x 0.85"
}
}
]
}
},
{
"identified_line": {
"line": "* Subjects must have the ability to understand and the willingness to sign a written informed consent document.",
"criterions": [
{
"exact_snippets": "ability to understand",
"criterion": "cognitive ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
"criterion": "willingness to consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ability to understand",
"criterion": "cognitive ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
"criterion": "willingness to consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:",
"criterions": [
{
"exact_snippets": "Evidence of post-menopausal status",
"criterion": "post-menopausal status",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "negative urinary or serum pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "amenorrheic for 12 months without an alternative medical cause",
"criterion": "amenorrhea duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Evidence of post-menopausal status",
"criterion": "post-menopausal status",
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"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "amenorrheic for 12 months without an alternative medical cause",
"criterion": "amenorrhea duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
]
},
{
"exact_snippets": "negative urinary or serum pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
}
},
{
"identified_line": {
"line": "* Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).",
"criterions": [
{
"exact_snippets": "Women <50 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 50,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "amenorrheic for 12 months or more",
"criterion": "amenorrhea duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 12,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "cessation of exogenous hormonal treatments",
"criterion": "exogenous hormonal treatment cessation",
"requirement": {
"requirement_type": "cessation",
"expected_value": true
}
},
{
"exact_snippets": "luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution",
"criterion": "hormone levels",
"requirement": {
"requirement_type": "range",
"expected_value": "post-menopausal range for the institution"
}
},
{
"exact_snippets": "surgical sterilization (bilateral oophorectomy or hysterectomy)",
"criterion": "surgical sterilization",
"requirement": {
"requirement_type": "procedure",
"expected_value": [
"bilateral oophorectomy",
"hysterectomy"
]
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"exact_snippets": "Women <50 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 50,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "amenorrheic for 12 months or more",
"criterion": "amenorrhea duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 12,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "cessation of exogenous hormonal treatments",
"criterion": "exogenous hormonal treatment cessation",
"requirement": {
"requirement_type": "cessation",
"expected_value": true
}
},
{
"exact_snippets": "luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution",
"criterion": "hormone levels",
"requirement": {
"requirement_type": "range",
"expected_value": "post-menopausal range for the institution"
}
}
]
},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "surgical sterilization (bilateral oophorectomy or hysterectomy)",
"criterion": "surgical sterilization",
"requirement": {
"requirement_type": "procedure",
"expected_value": [
"bilateral oophorectomy",
"hysterectomy"
]
}
}
}
},
{
"identified_line": {
"line": "* Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).",
"criterions": [
{
"exact_snippets": "Women ≥50 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "years"
}
}
},
{
"exact_snippets": "amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments",
"criterion": "amenorrhea duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
},
{
"exact_snippets": "radiation-induced menopause with last menses >1 year ago",
"criterion": "radiation-induced menopause",
"requirement": {
"requirement_type": "last menses duration",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
},
{
"exact_snippets": "chemotherapy-induced menopause with last menses >1 year ago",
"criterion": "chemotherapy-induced menopause",
"requirement": {
"requirement_type": "last menses duration",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
},
{
"exact_snippets": "surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)",
"criterion": "surgical sterilization",
"requirement": {
"requirement_type": "procedures",
"expected_value": [
"bilateral oophorectomy",
"bilateral salpingectomy",
"hysterectomy"
]
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Women ≥50 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "years"
}
}
},
"then_criteria": {
"or_criteria": [
{
"exact_snippets": "amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments",
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"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
},
{
"exact_snippets": "radiation-induced menopause with last menses >1 year ago",
"criterion": "radiation-induced menopause",
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"requirement_type": "last menses duration",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
},
{
"exact_snippets": "chemotherapy-induced menopause with last menses >1 year ago",
"criterion": "chemotherapy-induced menopause",
"requirement": {
"requirement_type": "last menses duration",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
},
{
"exact_snippets": "surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)",
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"requirement_type": "procedures",
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"bilateral oophorectomy",
"bilateral salpingectomy",
"hysterectomy"
]
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.",
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{
"exact_snippets": "Participant is willing and able to comply with the protocol",
"criterion": "willingness and ability to comply with protocol",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Participant is willing and able to comply with the protocol",
"criterion": "willingness and ability to comply with protocol",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "undergoing treatment",
"criterion": "undergoing treatment",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "scheduled visits and examinations",
"criterion": "scheduled visits and examinations",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "including follow up",
"criterion": "follow up",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Participant is willing and able to comply with the protocol",
"criterion": "willingness and ability to comply with protocol",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
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{
"exact_snippets": "Participant is willing and able to comply with the protocol",
"criterion": "willingness and ability to comply with protocol",
"requirement": {
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"expected_value": true
}
}
]
},
{
"exact_snippets": "undergoing treatment",
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"expected_value": true
}
},
{
"exact_snippets": "scheduled visits and examinations",
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"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "including follow up",
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"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
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]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 19 Years",
"criterions": [
{
"exact_snippets": "minimum age of 19 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 19,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 19 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 19,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Prior large field thoracic radiation therapy is not allowed except for at the discretion of the primary investigator. Prior SBRT to contralateral lung, or breast radiation greater than 3 years prior is allowed. Other prior thoracic radiation is allowed at the discretion of the primary investigator.",
"criterions": [
{
"exact_snippets": "Prior large field thoracic radiation therapy is not allowed",
"criterion": "prior large field thoracic radiation therapy",
"requirement": {
"requirement_type": "allowance",
"expected_value": false
}
},
{
"exact_snippets": "except for at the discretion of the primary investigator",
"criterion": "prior large field thoracic radiation therapy",
"requirement": {
"requirement_type": "allowance",
"expected_value": "at the discretion of the primary investigator"
}
},
{
"exact_snippets": "Prior SBRT to contralateral lung, or breast radiation greater than 3 years prior is allowed",
"criterion": "prior SBRT to contralateral lung",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
},
{
"exact_snippets": "breast radiation greater than 3 years prior is allowed",
"criterion": "prior breast radiation",
"requirement": {
"requirement_type": "time since radiation",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "years"
}
}
},
{
"exact_snippets": "breast radiation greater than 3 years prior is allowed",
"criterion": "prior breast radiation",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
},
{
"exact_snippets": "Other prior thoracic radiation is allowed at the discretion of the primary investigator",
"criterion": "other prior thoracic radiation",
"requirement": {
"requirement_type": "allowance",
"expected_value": "at the discretion of the primary investigator"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior large field thoracic radiation therapy is not allowed",
"criterion": "prior large field thoracic radiation therapy",
"requirement": {
"requirement_type": "allowance",
"expected_value": false
}
},
{
"not_criteria": {
"exact_snippets": "except for at the discretion of the primary investigator",
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}
}
}
]
}
]
}
},
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Prior SBRT to contralateral lung, or breast radiation greater than 3 years prior is allowed",
"criterion": "prior SBRT to contralateral lung",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
}
]
}
},
{
"not_criteria": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "breast radiation greater than 3 years prior is allowed",
"criterion": "prior breast radiation",
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"requirement_type": "time since radiation",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "years"
}
}
},
{
"exact_snippets": "breast radiation greater than 3 years prior is allowed",
"criterion": "prior breast radiation",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
}
]
}
]
}
},
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Other prior thoracic radiation is allowed at the discretion of the primary investigator",
"criterion": "other prior thoracic radiation",
"requirement": {
"requirement_type": "allowance",
"expected_value": "at the discretion of the primary investigator"
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* Prior radiation therapy, or immunotherapy for current diagnosis of NSCLC",
"criterions": [
{
"exact_snippets": "Prior radiation therapy",
"criterion": "radiation therapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
},
{
"exact_snippets": "immunotherapy for current diagnosis of NSCLC",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "current treatment",
"expected_value": true
}
},
{
"exact_snippets": "immunotherapy for current diagnosis of NSCLC",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "NSCLC"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior radiation therapy",
"criterion": "radiation therapy",
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"requirement_type": "prior treatment",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "immunotherapy for current diagnosis of NSCLC",
"criterion": "immunotherapy",
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"expected_value": true
}
},
{
"exact_snippets": "immunotherapy for current diagnosis of NSCLC",
"criterion": "immunotherapy",
"requirement": {
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.",
"criterions": [
{
"exact_snippets": "Female participants who are pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "male or female participants of reproductive potential",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy",
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"requirement_type": "willingness",
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}
}
]
},
"logical_structure": {
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{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Female participants who are pregnant",
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}
},
{
"exact_snippets": "breastfeeding",
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]
},
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"and_criteria": [
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}
},
{
"exact_snippets": "not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy",
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}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence",
"criterions": [
{
"exact_snippets": "Malignancy treated with curative intent",
"criterion": "malignancy treatment intent",
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}
},
{
"exact_snippets": "no known active disease",
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}
},
{
"exact_snippets": "≥2 years before the first dose of IP",
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"operator": ">=",
"value": 2,
"unit": "years"
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}
},
{
"exact_snippets": "low potential risk for recurrence",
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}
]
},
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{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Malignancy treated with curative intent",
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},
{
"exact_snippets": "no known active disease",
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}
]
},
{
"exact_snippets": "≥2 years before the first dose of IP",
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"value": 2,
"unit": "years"
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}
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]
},
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"exact_snippets": "low potential risk for recurrence",
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}
]
}
]
}
},
{
"identified_line": {
"line": "* Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.",
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{
"exact_snippets": "irreversible toxicity",
"criterion": "irreversible toxicity",
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}
]
},
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}
},
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"criterion": "consultation with Study Physician",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
}
},
{
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"line": "* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.",
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{
"exact_snippets": "Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.",
"criterion": "major surgical procedure",
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"requirement_type": "time since procedure",
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"operator": "<=",
"value": 28,
"unit": "days"
}
}
}
]
},
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"not_criteria": {
"exact_snippets": "Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.",
"criterion": "major surgical procedure",
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"requirement_type": "time since procedure",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
}
}
},
{
"identified_line": {
"line": "* Judgment by the investigator that the participant is unsuitable to participate in the study and the participant is unlikely to comply with study procedures, restrictions and requirements",
"criterions": [
{
"exact_snippets": "Judgment by the investigator that the participant is unsuitable to participate in the study",
"criterion": "suitability for study",
"requirement": {
"requirement_type": "judgment",
"expected_value": "unsuitable"
}
},
{
"exact_snippets": "the participant is unlikely to comply with study procedures, restrictions and requirements",
"criterion": "compliance with study procedures, restrictions and requirements",
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"requirement_type": "likelihood",
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Judgment by the investigator that the participant is unsuitable to participate in the study",
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"requirement_type": "judgment",
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}
},
{
"exact_snippets": "the participant is unlikely to comply with study procedures, restrictions and requirements",
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"requirement_type": "likelihood",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "Medication Specific Exclusion Criterion:",
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{
"exact_snippets": "Medication Specific Exclusion Criterion",
"criterion": "medication",
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"requirement_type": "exclusion",
"expected_value": true
}
}
]
},
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"not_criteria": {
"exact_snippets": "Medication Specific Exclusion Criterion",
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"requirement_type": "exclusion",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* History of primary immunodeficiency",
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{
"exact_snippets": "History of primary immunodeficiency",
"criterion": "primary immunodeficiency",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "History of primary immunodeficiency",
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"requirement_type": "history",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Participants with vitiligo or alopecia",
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{
"exact_snippets": "Participants with vitiligo",
"criterion": "vitiligo",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Participants with ... alopecia",
"criterion": "alopecia",
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"requirement_type": "presence",
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}
}
]
},
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"or_criteria": [
{
"exact_snippets": "Participants with vitiligo",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Participants with ... alopecia",
"criterion": "alopecia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement",
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{
"exact_snippets": "Participants with hypothyroidism",
"criterion": "hypothyroidism",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "stable on hormone replacement",
"criterion": "hormone replacement",
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"requirement_type": "stability",
"expected_value": true
}
}
]
},
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"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Participants with hypothyroidism",
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"requirement_type": "presence",
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},
{
"exact_snippets": "stable on hormone replacement",
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"requirement_type": "stability",
"expected_value": true
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* Any chronic skin condition that does not require systemic therapy",
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{
"exact_snippets": "chronic skin condition",
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"requirement_type": "treatment requirement",
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}
}
]
},
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"not_criteria": {
"exact_snippets": "chronic skin condition",
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"requirement_type": "treatment requirement",
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}
}
}
},
{
"identified_line": {
"line": "* Participants without active disease in the last 5 years may be included but only after consultation with the study physician",
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{
"exact_snippets": "without active disease",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "in the last 5 years",
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"requirement_type": "duration",
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"operator": "<=",
"value": 5,
"unit": "years"
}
}
}
]
},
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{
"exact_snippets": "without active disease",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "in the last 5 years",
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"requirement_type": "duration",
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"operator": "<=",
"value": 5,
"unit": "years"
}
}
}
]
},
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"exact_snippets": "consultation with the study physician",
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"requirement_type": "approval",
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}
},
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}
},
{
"identified_line": {
"line": "* Participants with celiac disease controlled by diet alone",
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{
"exact_snippets": "Participants with celiac disease",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "controlled by diet alone",
"criterion": "celiac disease control",
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"requirement_type": "method",
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}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Participants with celiac disease",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "controlled by diet alone",
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"requirement_type": "method",
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}
}
]
}
},
{
"identified_line": {
"line": "* Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation",
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{
"exact_snippets": "prior allogeneic bone marrow transplantation",
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"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "prior solid organ transplantation",
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"requirement_type": "history",
"expected_value": true
}
}
]
},
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{
"exact_snippets": "prior allogeneic bone marrow transplantation",
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"requirement_type": "history",
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}
},
{
"exact_snippets": "prior solid organ transplantation",
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"requirement_type": "history",
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}
]
}
},
{
"identified_line": {
"line": "* Treatment with systemic immunosuppressive medications (including but not limited to prednisone > 10 mg daily, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1. However, the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for participants with orthostatic hypotension or adrenocortical insufficiency is allowed.",
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{
"exact_snippets": "Treatment with systemic immunosuppressive medications (including but not limited to prednisone > 10 mg daily, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1.",
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"requirement_type": "treatment",
"expected_value": false
}
},
{
"exact_snippets": "use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for participants with orthostatic hypotension or adrenocortical insufficiency is allowed.",
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"requirement": {
"requirement_type": "use",
"expected_value": true
}
}
]
},
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"condition": {
"exact_snippets": "Treatment with systemic immunosuppressive medications (including but not limited to prednisone > 10 mg daily, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1.",
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"requirement_type": "treatment",
"expected_value": false
}
},
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"not_criteria": {
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"requirement_type": "use",
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}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.",
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{
"exact_snippets": "Known allergy or hypersensitivity to any of the study drugs",
"criterion": "allergy or hypersensitivity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Known allergy or hypersensitivity to ... any of the study drug excipients",
"criterion": "allergy or hypersensitivity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Known allergy or hypersensitivity to any of the study drugs",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Known allergy or hypersensitivity to ... any of the study drug excipients",
"criterion": "allergy or hypersensitivity",
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"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent",
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{
"exact_snippets": "Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection",
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"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "ongoing or active infection",
"criterion": "infection",
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"requirement_type": "status",
"expected_value": [
"ongoing",
"active"
]
}
},
{
"exact_snippets": "symptomatic congestive heart failure",
"criterion": "congestive heart failure",
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"requirement_type": "symptoms",
"expected_value": true
}
},
{
"exact_snippets": "uncontrolled hypertension",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "unstable angina pectoris",
"criterion": "angina pectoris",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
},
{
"exact_snippets": "cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "interstitial lung disease",
"criterion": "interstitial lung disease",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "serious chronic gastrointestinal conditions associated with diarrhea",
"criterion": "chronic gastrointestinal conditions",
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"expected_value": "serious"
}
},
{
"exact_snippets": "serious chronic gastrointestinal conditions associated with diarrhea",
"criterion": "chronic gastrointestinal conditions",
"requirement": {
"requirement_type": "association",
"expected_value": "diarrhea"
}
},
{
"exact_snippets": "psychiatric illness/social situations that would limit compliance with study requirement",
"criterion": "psychiatric illness/social situations",
"requirement": {
"requirement_type": "impact on compliance",
"expected_value": "limit"
}
},
{
"exact_snippets": "psychiatric illness/social situations that would ... substantially increase risk of incurring AEs",
"criterion": "psychiatric illness/social situations",
"requirement": {
"requirement_type": "impact on risk",
"expected_value": "substantially increase"
}
},
{
"exact_snippets": "psychiatric illness/social situations that would ... compromise the ability of the participant to give written informed consent",
"criterion": "psychiatric illness/social situations",
"requirement": {
"requirement_type": "impact on consent ability",
"expected_value": "compromise"
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection",
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},
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]
},
{
"exact_snippets": "symptomatic congestive heart failure",
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}
},
{
"exact_snippets": "uncontrolled hypertension",
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},
{
"exact_snippets": "unstable angina pectoris",
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"requirement_type": "stability",
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}
},
{
"exact_snippets": "cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "interstitial lung disease",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"and_criteria": [
{
"exact_snippets": "serious chronic gastrointestinal conditions associated with diarrhea",
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"expected_value": "serious"
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},
{
"exact_snippets": "serious chronic gastrointestinal conditions associated with diarrhea",
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}
]
},
{
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"expected_value": "limit"
}
},
{
"exact_snippets": "psychiatric illness/social situations that would ... substantially increase risk of incurring AEs",
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}
},
{
"exact_snippets": "psychiatric illness/social situations that would ... compromise the ability of the participant to give written informed consent",
"criterion": "psychiatric illness/social situations",
"requirement": {
"requirement_type": "impact on consent ability",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Participants, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.",
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{
"exact_snippets": "Receipt of live attenuated vaccine within 30 days prior to the first dose of IP",
"criterion": "live attenuated vaccine receipt",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days prior to first dose of IP"
}
}
},
{
"exact_snippets": "Participants, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP",
"criterion": "live vaccine receipt",
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"expected_value": "not allowed during IP and up to 30 days after last dose of IP"
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}
]
},
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{
"and_criteria": [
{
"exact_snippets": "Receipt of live attenuated vaccine within 30 days prior to the first dose of IP",
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"operator": "<=",
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"unit": "days prior to first dose of IP"
}
}
},
{
"exact_snippets": "Participants, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP",
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}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* ECOG performance status 0-2",
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"exact_snippets": "ECOG performance status 0-2",
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"requirement_type": "range",
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{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
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}
},
{
"identified_line": {
"line": "* Body Weight >30kg",
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{
"exact_snippets": "Body Weight >30kg",
"criterion": "body weight",
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"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 30,
"unit": "kg"
}
}
}
]
},
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}
},
{
"identified_line": {
"line": "* Must have anticipated life expectancy of at least 12 weeks",
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{
"exact_snippets": "anticipated life expectancy of at least 12 weeks",
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"requirement_type": "duration",
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"operator": ">=",
"value": 12,
"unit": "weeks"
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}
}
]
},
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}
},
{
"identified_line": {
"line": "* Must be histologically or cytologically confirmed to be non-small cell lung cancer (NSCLC) confirmed by biopsy within 90 days of registration.",
"criterions": [
{
"exact_snippets": "Must be histologically or cytologically confirmed to be non-small cell lung cancer (NSCLC)",
"criterion": "non-small cell lung cancer (NSCLC)",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "confirmed by biopsy within 90 days of registration",
"criterion": "biopsy confirmation",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days"
}
}
}
]
},
"logical_structure": {
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}
}
},
{
"identified_line": {
"line": "* Any tumor PD-L1 expression is allowed (including 0% to 100%, or unknown at time of study enrollment)",
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"exact_snippets": "Any tumor PD-L1 expression is allowed (including 0% to 100%, or unknown at time of study enrollment)",
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"requirement_type": "range",
"expected_value": "any"
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}
]
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}
}
},
{
"identified_line": {
"line": "* AJCC 8th Stage IIA-IIIC.",
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{
"exact_snippets": "AJCC 8th Stage IIA-IIIC",
"criterion": "AJCC stage",
"requirement": {
"requirement_type": "range",
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"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "A"
},
{
"operator": "<=",
"value": 3,
"unit": "C"
}
]
}
}
}
]
},
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"criterion": "failed",
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Pulmonary function testing performed within 365 days prior to registration. . Sufficient lung function as judged by the primary investigator based on anticipated radiation fields, with a minimum of FEV1 ≥ 0.7 Liter or ≥ 30% and DLCO ≥ 30% with or without bronchodilator within 365 days prior to registration.",
"criterions": [
{
"exact_snippets": "Pulmonary function testing performed within 365 days prior to registration.",
"criterion": "pulmonary function testing",
"requirement": {
"requirement_type": "timing",
"expected_value": "within 365 days prior to registration"
}
},
{
"exact_snippets": "Sufficient lung function as judged by the primary investigator based on anticipated radiation fields",
"criterion": "lung function",
"requirement": {
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"expected_value": "as judged by the primary investigator based on anticipated radiation fields"
}
},
{
"exact_snippets": "minimum of FEV1 ≥ 0.7 Liter or ≥ 30%",
"criterion": "FEV1",
"requirement": {
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{
"operator": ">=",
"value": 0.7,
"unit": "Liter"
},
{
"operator": ">=",
"value": 30,
"unit": "%"
}
]
}
}
},
{
"exact_snippets": "DLCO ≥ 30%",
"criterion": "DLCO",
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"operator": ">=",
"value": 30,
"unit": "%"
}
}
},
{
"exact_snippets": "with or without bronchodilator within 365 days prior to registration",
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}
}
]
},
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{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Pulmonary function testing performed within 365 days prior to registration.",
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}
},
{
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}
}
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{
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}
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}
}
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}
}
]
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Concurrent enrolment in another clinical study",
"criterion": "concurrent enrolment in another clinical study",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
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"criterion": "enrolment in observational clinical study",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "during the follow-up period of an interventional study",
"criterion": "enrolment during follow-up period of interventional study",
"requirement": {
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}
}
]
},
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{
"exact_snippets": "Concurrent enrolment in another clinical study",
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"expected_value": true
}
},
{
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{
"exact_snippets": "unless it is an observational (non-interventional) clinical study",
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"expected_value": true
}
},
{
"exact_snippets": "during the follow-up period of an interventional study",
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}
}
]
}
}
]
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "* History of another primary malignancy except for:",
"criterions": [
{
"exact_snippets": "History of another primary malignancy",
"criterion": "history of another primary malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "History of another primary malignancy",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease",
"criterions": [
{
"exact_snippets": "Adequately treated non-melanoma skin cancer",
"criterion": "non-melanoma skin cancer",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
},
{
"exact_snippets": "lentigo maligna without evidence of disease",
"criterion": "lentigo maligna",
"requirement": {
"requirement_type": "disease status",
"expected_value": "without evidence of disease"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
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}
}
},
{
"identified_line": {
"line": "* Adequately treated carcinoma in situ (i.e. breast) without evidence of disease",
"criterions": [
{
"exact_snippets": "Adequately treated carcinoma in situ",
"criterion": "carcinoma in situ",
"requirement": {
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"expected_value": "adequately treated"
}
},
{
"exact_snippets": "without evidence of disease",
"criterion": "evidence of disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Low risk prostate cancer which has been treated or is undergoing active surveillance.",
"criterions": [
{
"exact_snippets": "Low risk prostate cancer",
"criterion": "prostate cancer risk level",
"requirement": {
"requirement_type": "risk level",
"expected_value": "low"
}
},
{
"exact_snippets": "has been treated",
"criterion": "treatment status",
"requirement": {
"requirement_type": "treatment",
"expected_value": true
}
},
{
"exact_snippets": "is undergoing active surveillance",
"criterion": "active surveillance status",
"requirement": {
"requirement_type": "active surveillance",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
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"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria",
"criterions": [
{
"exact_snippets": "unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy",
"criterion": "unresolved toxicity from previous anticancer therapy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "NCI CTCAE Grade"
}
}
},
{
"exact_snippets": "alopecia",
"criterion": "alopecia",
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"expected_value": false
}
},
{
"exact_snippets": "vitiligo",
"criterion": "vitiligo",
"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Participants with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.",
"criterions": [
{
"exact_snippets": "Grade ≥2 neuropathy",
"criterion": "neuropathy",
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"expected_value": {
"operator": ">=",
"value": 2,
"unit": "Grade"
}
}
}
]
},
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"requirement": {
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}
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc])",
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}
}
]
},
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"exact_snippets": "failed",
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"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Active infection including tuberculosis",
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice)",
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "hepatitis B (known positive hepatitis B surface antigen [HBsAg] result)",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hepatitis C",
"criterion": "hepatitis C",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "human immunodeficiency virus (positive human immunodeficiency virus [HIV] 1/2 antibodies)",
"criterion": "human immunodeficiency virus",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Participants with a past or resolved hepatitis B (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible",
"criterion": "past or resolved hepatitis B infection",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
},
{
"exact_snippets": "Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA",
"criterion": "hepatitis C antibody",
"requirement": {
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"expected_value": {
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"value": 0,
"unit": "HCV RNA"
}
}
}
]
},
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"or_criteria": [
{
"and_criteria": [
{
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"expected_value": true
}
},
{
"exact_snippets": "hepatitis B (known positive hepatitis B surface antigen [HBsAg] result)",
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}
},
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"expected_value": true
}
},
{
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}
}
]
},
{
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Participants with a past or resolved hepatitis B (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible",
"criterion": "past or resolved hepatitis B infection",
"requirement": {
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"expected_value": true
}
}
]
},
{
"and_criteria": [
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"criterion": "hepatitis C",
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"expected_value": true
}
},
{
"exact_snippets": "Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA",
"criterion": "hepatitis C antibody",
"requirement": {
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"expected_value": {
"operator": "=",
"value": 0,
"unit": "HCV RNA"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
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"criterions": [
{
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"criterion": "prior participation in durvalumab and/or tremelimumab clinical study",
"requirement": {
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"expected_value": true
}
}
]
},
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"or_criteria": [
{
"exact_snippets": "Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study",
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"expected_value": true
}
},
{
"exact_snippets": "Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study",
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"requirement": {
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"expected_value": true
}
}
]
}
]
}
}
],
"failed_miscellaneous": []
}