{
"info": {
"nct_id": "NCT00118131",
"official_title": "Phase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy-Naive Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria:\n\n * Stage IIIB disease with malignant pericardial or malignant pleural effusions, as indicated by 1 of the following:\n\n * Positive cytology\n * Exudative effusion AND lactic dehydrogenase (LDH) > 200 IU with effusion/serum LDH ratio ≥ 0.6\n * Stage IV disease\n* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan\n* Brain metastases allowed provided they have been irradiated AND are radiographically stable for ≥ 28 days after the completion of radiotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm^3\n* Platelet count ≥ 100,000/mm^3\n* Hemoglobin ≥ 8.0 g/dL\n\nHepatic\n\n* AST and ALT normal\n* Bilirubin normal\n\nRenal\n\n* Creatinine clearance ≥ 50 mL/min\n\nImmunologic\n\n* No known HIV positivity\n* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80\n* No clinically significant active infection\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment\n* No other primary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No other serious systemic disorder that would preclude study participation\n* No other condition that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Prior antibody-based therapy that targets growth factor pathways (e.g., epidermal growth factor receptor [EGFR]) allowed provided there is disease progression during therapy and patient has recovered\n* No concurrent immunotherapy\n* No concurrent prophylactic colony-stimulating factors\n* No concurrent interleukin-11\n\nChemotherapy\n\n* No prior cytotoxic chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent hormonal therapy for the malignancy\n\nRadiotherapy\n\n* See Disease Characteristics\n* More than 28 days since prior radiotherapy and recovered\n* No prior radiotherapy to ≥ 25% of the bone marrow\n* No prior radiotherapy to sites of measurable disease unless there is documented tumor progression after completion of radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* No concurrent surgery for the malignancy\n\nOther\n\n* More than 3 weeks since prior investigational drugs\n* Prior oral small molecule drug therapy that targets growth factor pathways (e.g., EGFR) allowed provided there is disease progression during therapy and patient has recovered\n* No other concurrent investigational or commercial agents or therapies for the malignancy"
},
"inclusion_lines": [
{
"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": {
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"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",
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"value": 18,
"unit": "Years"
}
}
}
]
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},
{
"identified_line": {
"line": "Must have maximum age of 120 Years",
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{
"exact_snippets": "maximum age of 120 Years",
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"requirement": {
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"expected_value": {
"operator": "<=",
"value": 120,
"unit": "Years"
}
}
}
]
},
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{
"exact_snippets": "maximum age of 120 Years",
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"operator": "<=",
"value": 120,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "* Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria:",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
}
]
},
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{
"exact_snippets": "Histologically or cytologically confirmed non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
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"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
}
]
}
},
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"line": "* Stage IIIB disease with malignant pericardial or malignant pleural effusions, as indicated by 1 of the following:",
"criterions": [
{
"exact_snippets": "Stage IIIB disease",
"criterion": "disease stage",
"requirement": {
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"expected_value": "IIIB"
}
},
{
"exact_snippets": "malignant pericardial ... effusions",
"criterion": "pericardial effusions",
"requirement": {
"requirement_type": "malignancy",
"expected_value": true
}
},
{
"exact_snippets": "malignant ... pleural effusions",
"criterion": "pleural effusions",
"requirement": {
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"expected_value": true
}
}
]
},
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"exact_snippets": "Stage IIIB disease",
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}
},
{
"or_criteria": [
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"exact_snippets": "malignant pericardial ... effusions",
"criterion": "pericardial effusions",
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"expected_value": true
}
},
{
"exact_snippets": "malignant ... pleural effusions",
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"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Positive cytology",
"criterions": [
{
"exact_snippets": "Positive cytology",
"criterion": "cytology",
"requirement": {
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"expected_value": "positive"
}
}
]
},
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"exact_snippets": "Positive cytology",
"criterion": "cytology",
"requirement": {
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}
}
]
}
},
{
"identified_line": {
"line": "* Exudative effusion AND lactic dehydrogenase (LDH) > 200 IU with effusion/serum LDH ratio ≥ 0.6",
"criterions": [
{
"exact_snippets": "Exudative effusion",
"criterion": "exudative effusion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "lactic dehydrogenase (LDH) > 200 IU",
"criterion": "lactic dehydrogenase (LDH)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 200,
"unit": "IU"
}
}
},
{
"exact_snippets": "effusion/serum LDH ratio ≥ 0.6",
"criterion": "effusion/serum LDH ratio",
"requirement": {
"requirement_type": "ratio",
"expected_value": {
"operator": ">=",
"value": 0.6,
"unit": "N/A"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Exudative effusion",
"criterion": "exudative effusion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "lactic dehydrogenase (LDH) > 200 IU",
"criterion": "lactic dehydrogenase (LDH)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 200,
"unit": "IU"
}
}
},
{
"exact_snippets": "effusion/serum LDH ratio ≥ 0.6",
"criterion": "effusion/serum LDH ratio",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 0.6,
"unit": "N/A"
}
}
}
]
}
},
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"identified_line": {
"line": "* Stage IV disease",
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{
"exact_snippets": "Stage IV disease",
"criterion": "disease stage",
"requirement": {
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"expected_value": "IV"
}
}
]
},
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}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques",
"criterion": "unidimensionally measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques",
"criterion": "unidimensionally measurable lesion",
"requirement": {
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"expected_value": {
"operator": ">",
"value": 20,
"unit": "mm"
}
}
},
{
"exact_snippets": "Measurable disease, defined as ... > 10 mm by spiral CT scan",
"criterion": "unidimensionally measurable lesion",
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
}
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"operator": ">",
"value": 10,
"unit": "mm"
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"unit": "mm"
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},
{
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"line": "* Brain metastases allowed provided they have been irradiated AND are radiographically stable for ≥ 28 days after the completion of radiotherapy",
"criterions": [
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"exact_snippets": "Brain metastases allowed provided they have been irradiated",
"criterion": "brain metastases",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Brain metastases ... are radiographically stable for ≥ 28 days after the completion of radiotherapy",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "stability",
"expected_value": {
"operator": ">=",
"value": 28,
"unit": "days"
}
}
}
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"logical_structure": {
"and_criteria": [
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"exact_snippets": "Brain metastases allowed provided they have been irradiated",
"criterion": "brain metastases",
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"expected_value": true
}
},
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"exact_snippets": "Brain metastases ... are radiographically stable for ≥ 28 days after the completion of radiotherapy",
"criterion": "brain metastases",
"requirement": {
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"expected_value": {
"operator": ">=",
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"unit": "days"
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}
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{
"identified_line": {
"line": "Age",
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{
"exact_snippets": "Age",
"criterion": "age",
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}
]
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"identified_line": {
"line": "* 18 and over",
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{
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"value": 18,
"unit": "years"
}
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"exact_snippets": "18 and over",
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"identified_line": {
"line": "Performance status",
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"exact_snippets": "Performance status",
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"expected_value": "N/A"
}
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"exact_snippets": "Performance status",
"criterion": "performance status",
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}
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},
{
"identified_line": {
"line": "* ECOG 0-1",
"criterions": [
{
"exact_snippets": "ECOG 0-1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
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"exact_snippets": "ECOG 0-1",
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"requirement": {
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{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "Life expectancy",
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{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirement": {
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirement": {
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"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* At least 12 weeks",
"criterions": [
{
"exact_snippets": "At least 12 weeks",
"criterion": "duration",
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"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
},
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{
"exact_snippets": "At least 12 weeks",
"criterion": "duration",
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"operator": ">=",
"value": 12,
"unit": "weeks"
}
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]
}
},
{
"identified_line": {
"line": "Hematopoietic",
"criterions": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic system",
"requirement": {
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"expected_value": true
}
}
]
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"and_criteria": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic system",
"requirement": {
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"expected_value": true
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}
]
}
},
{
"identified_line": {
"line": "* Absolute neutrophil count ≥ 1,500/mm^3",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count ≥ 1,500/mm^3",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm^3"
}
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"exact_snippets": "Absolute neutrophil count ≥ 1,500/mm^3",
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"operator": ">=",
"value": 1500,
"unit": "mm^3"
}
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{
"identified_line": {
"line": "* Platelet count ≥ 100,000/mm^3",
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"exact_snippets": "Platelet count ≥ 100,000/mm^3",
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"operator": ">=",
"value": 100000,
"unit": "mm^3"
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"exact_snippets": "Platelet count ≥ 100,000/mm^3",
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"operator": ">=",
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"identified_line": {
"line": "* Hemoglobin ≥ 8.0 g/dL",
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"exact_snippets": "Hemoglobin ≥ 8.0 g/dL",
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"value": 8.0,
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"identified_line": {
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{
"identified_line": {
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},
{
"identified_line": {
"line": "* Bilirubin normal",
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"exact_snippets": "Bilirubin normal",
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"exact_snippets": "Bilirubin normal",
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}
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]
}
},
{
"identified_line": {
"line": "Renal",
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{
"exact_snippets": "Renal",
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"expected_value": true
}
}
]
},
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"exact_snippets": "Renal",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine clearance ≥ 50 mL/min",
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{
"exact_snippets": "Creatinine clearance ≥ 50 mL/min",
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"requirement_type": "value",
"expected_value": {
"operator": ">=",
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"unit": "mL/min"
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}
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"exact_snippets": "Creatinine clearance ≥ 50 mL/min",
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"operator": ">=",
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"unit": "mL/min"
}
}
}
]
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},
{
"identified_line": {
"line": "Immunologic",
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{
"exact_snippets": "Immunologic",
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"expected_value": true
}
}
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"exact_snippets": "Prior oral small molecule drug therapy that targets growth factor pathways (e.g., EGFR)",
"criterion": "prior oral small molecule drug therapy",
"requirement": {
"requirement_type": "target",
"expected_value": "growth factor pathways (e.g., EGFR)"
}
},
{
"exact_snippets": "Prior oral small molecule drug therapy that targets growth factor pathways (e.g., EGFR)",
"criterion": "prior oral small molecule drug therapy",
"requirement": {
"requirement_type": "status",
"expected_value": "allowed"
}
},
{
"exact_snippets": "disease progression during therapy",
"criterion": "disease progression",
"requirement": {
"requirement_type": "timing",
"expected_value": "during therapy"
}
},
{
"exact_snippets": "patient has recovered",
"criterion": "recovery",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
]
}