{
"info": {
"nct_id": "NCT06267001",
"official_title": "A Phase III, Randomized, Double-blind Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy",
"inclusion_criteria": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology\n* Participants must have had complete resection of NSCLC\n* Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy\n* Participants must have recovered adequately from surgery and from adjuvant chemotherapy\n* Tumor cell PD-L1 expression at >/= 1%\n* Adequate hematologic and end-organ function.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Any history of prior NSCLC within the last 5 years\n* Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy\n* NSCLC known to have mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Participants must have had complete resection of NSCLC",
"criterions": [
{
"exact_snippets": "complete resection of NSCLC",
"criterion": "NSCLC resection",
"requirement": {
"requirement_type": "completeness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "complete resection of NSCLC",
"criterion": "NSCLC resection",
"requirement": {
"requirement_type": "completeness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy",
"criterions": [
{
"exact_snippets": "Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy",
"criterion": "adjuvant histology-based platinum doublet chemotherapy",
"requirement": {
"requirement_type": "cycles received",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "cycles"
},
{
"operator": "<=",
"value": 4,
"unit": "cycles"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy",
"criterion": "adjuvant histology-based platinum doublet chemotherapy",
"requirement": {
"requirement_type": "cycles received",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "cycles"
},
{
"operator": "<=",
"value": 4,
"unit": "cycles"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Participants must have recovered adequately from surgery and from adjuvant chemotherapy",
"criterions": [
{
"exact_snippets": "Participants must have recovered adequately from surgery",
"criterion": "recovery from surgery",
"requirement": {
"requirement_type": "recovery",
"expected_value": "adequate"
}
},
{
"exact_snippets": "Participants must have recovered adequately ... from adjuvant chemotherapy",
"criterion": "recovery from adjuvant chemotherapy",
"requirement": {
"requirement_type": "recovery",
"expected_value": "adequate"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Participants must have recovered adequately from surgery",
"criterion": "recovery from surgery",
"requirement": {
"requirement_type": "recovery",
"expected_value": "adequate"
}
},
{
"exact_snippets": "Participants must have recovered adequately ... from adjuvant chemotherapy",
"criterion": "recovery from adjuvant chemotherapy",
"requirement": {
"requirement_type": "recovery",
"expected_value": "adequate"
}
}
]
}
},
{
"identified_line": {
"line": "* Tumor cell PD-L1 expression at >/= 1%",
"criterions": [
{
"exact_snippets": "Tumor cell PD-L1 expression at >/= 1%",
"criterion": "tumor cell PD-L1 expression",
"requirement": {
"requirement_type": "expression level",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Tumor cell PD-L1 expression at >/= 1%",
"criterion": "tumor cell PD-L1 expression",
"requirement": {
"requirement_type": "expression level",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate hematologic and end-organ function.",
"criterions": [
{
"exact_snippets": "Adequate hematologic ... function.",
"criterion": "hematologic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... end-organ function.",
"criterion": "end-organ function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate hematologic ... function.",
"criterion": "hematologic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... end-organ function.",
"criterion": "end-organ function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Any history of prior NSCLC within the last 5 years",
"criterions": [
{
"exact_snippets": "Any history of prior NSCLC within the last 5 years",
"criterion": "history of prior NSCLC",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Any history of prior NSCLC within the last 5 years",
"criterion": "history of prior NSCLC",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy",
"criterions": [
{
"exact_snippets": "evidence of residual disease",
"criterion": "residual disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "disease recurrence",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "surgical resection of NSCLC",
"criterion": "surgical resection of NSCLC",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "adjuvant chemotherapy",
"criterion": "adjuvant chemotherapy",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "evidence of residual disease",
"criterion": "residual disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "surgical resection of NSCLC",
"criterion": "surgical resection of NSCLC",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
{
"exact_snippets": "adjuvant chemotherapy",
"criterion": "adjuvant chemotherapy",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
{
"exact_snippets": "disease recurrence",
"criterion": "disease recurrence",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* NSCLC known to have mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene",
"criterions": [
{
"exact_snippets": "NSCLC known to have mutation in the epidermal growth factor receptor (EGFR) gene",
"criterion": "EGFR gene mutation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "NSCLC known to have ... an anaplastic lymphoma kinase (ALK) fusion oncogene",
"criterion": "ALK fusion oncogene",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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{
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"criterion": "EGFR gene mutation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "NSCLC known to have ... an anaplastic lymphoma kinase (ALK) fusion oncogene",
"criterion": "ALK fusion oncogene",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
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"expected_value": [
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"1"
]
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"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
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"expected_value": "0"
}
},
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
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}
}
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},
{
"identified_line": {
"line": "* Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology",
"criterions": [
{
"exact_snippets": "Histological or cytological diagnosis",
"criterion": "diagnosis method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histological",
"cytological"
]
}
},
{
"exact_snippets": "Stage IIB, IIIA, and select IIIB NSCLC",
"criterion": "NSCLC stage",
"requirement": {
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"IIIA",
"select IIIB"
]
}
},
{
"exact_snippets": "non-squamous or squamous histology",
"criterion": "NSCLC histology",
"requirement": {
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"non-squamous",
"squamous"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histological or cytological diagnosis",
"criterion": "diagnosis method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histological",
"cytological"
]
}
},
{
"exact_snippets": "Stage IIB, IIIA, and select IIIB NSCLC",
"criterion": "NSCLC stage",
"requirement": {
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"expected_value": [
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"IIIA",
"select IIIB"
]
}
}
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"or_criteria": [
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}
},
{
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"requirement": {
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"expected_value": "squamous"
}
}
]
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}