{
"info": {
"nct_id": "NCT04197076",
"official_title": "An Open, Observational Clinical Study, 2-3 Cycles Treatment as Neoadjuvant Therapy for NSCLC With Stage IIB-IIIB",
"inclusion_criteria": "1. Primary non-small cell lung cancer confirmed by cytology or histology\n2. According to the TNM stage (8th Edition) of IASLC lung cancer, it is determined to be IIB-IIIB stage non-small cell lung cancer, which is considered to be resectable;\n3. There must be at least one evaluable focus judged according to recist1.1 standard (the longest diameter on spiral CT is at least 10 mm, and the longest diameter on general CT is at least 20 mm)\n4. ECOG PS 0 or 1\n5. There are tumor samples available for gene detection (EGFR / ALK / ros1) and PD-L1 immunohistochemistry (IHC) in the subjects, and the tumor samples should be obtained within 3 months before enrollment.\n6. If all suspected mediastinal lymph nodes (including those with pathological enlargement or FDG concentration on PET / CT) can be examined by EBUS, thoracoscopy or mediastinoscopy, further sampling is required for pathological confirmation.\n7. Male or female, ≥ 18 years old\n8. Adequate blood function: absolute neutrophil count (ANC) ≥ 2 × 109 / L, platelet count ≥ 100 × 109 / L and hemoglobin 110 ≥ 9 g / dl\n9. Adequate liver function: total bilirubin ≤ upper limit of normal value (ULN); AST and alt ≤ upper limit of normal value (ULN); alkaline phosphatase ≤ upper limit of normal value (ULN)\n10. Adequate renal function: serum creatinine ≤ upper limit of normal value (ULN) or calculated creatinine clearance ≥ 60ml / min\n11. No anti-tumor drug treatment in the past\n12. For patients who have had previous surgery, it is required that more than 4 weeks have passed since the start of study treatment, and the patients have recovered\n13. Women with a full uterus must have negative pregnancy test results within 28 days before entering the study (unless it is 24 months after amenorrhea). If the pregnancy test is more than 7 days from the first administration, a urine pregnancy test is required for verification (within 7 days before the first administration)\n14. Sign the informed consent form (the informed consent form needs to be approved by the independent ethics committee, and the informed consent of the patient should be obtained before starting any substantive trial procedure)\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "1. Have other malignant tumors in the last 5 years\n2. AST and / or ALT > 2.5 times of the upper limit of normal value (ULN), with alkaline phosphatase > 5 times of the upper limit of normal value (ULN)\n3. Previously received radiotherapy\n4. Previously used chemotherapy drugs, targeted and immunotherapy drugs (except bisphosphonates)\n5. There are any uncontrolled systemic diseases, including active infection, uncontrolled hypertension, diabetes, unstable angina, congestive heart failure, myocardial infarction (within 1 year before treatment), serious arrhythmia requiring drug treatment, liver, kidney and metabolic diseases\n6. Women in pregnancy or lactation\n7. The patient (male or female) has the possibility of childbearing but is unwilling or does not take effective contraceptive measures\n8. Receive the experimental treatment of other clinical studies at the same time (in the treatment period of clinical studies)\n9. Known to be allergic to possible chemotherapy drugs\n10. There is evidence of other diseases, neurological or metabolic dysfunction, abnormal physical examination or laboratory examination, and it is suspected that there may be a high risk of contraindications to the study drug or complications related to treatment",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Primary non-small cell lung cancer confirmed by cytology or histology",
"criterions": [
{
"exact_snippets": "Primary non-small cell lung cancer",
"criterion": "primary non-small cell lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "confirmed by cytology or histology",
"criterion": "confirmation method",
"requirements": [
{
"requirement_type": "method",
"expected_value": [
"cytology",
"histology"
]
}
]
}
]
},
{
"line": "2. According to the TNM stage (8th Edition) of IASLC lung cancer, it is determined to be IIB-IIIB stage non-small cell lung cancer, which is considered to be resectable;",
"criterions": [
{
"exact_snippets": "TNM stage (8th Edition) of IASLC lung cancer ... IIB-IIIB stage non-small cell lung cancer",
"criterion": "TNM stage of IASLC lung cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "IIB"
},
{
"operator": "<=",
"value": 3,
"unit": "IIIB"
}
]
}
}
]
},
{
"exact_snippets": "resectable",
"criterion": "resectability",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
}
]
},
{
"line": "3. There must be at least one evaluable focus judged according to recist1.1 standard (the longest diameter on spiral CT is at least 10 mm, and the longest diameter on general CT is at least 20 mm)",
"criterions": [
{
"exact_snippets": "at least one evaluable focus judged according to recist1.1 standard",
"criterion": "evaluable focus",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "the longest diameter on spiral CT is at least 10 mm",
"criterion": "longest diameter on spiral CT",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mm"
}
}
]
},
{
"exact_snippets": "the longest diameter on general CT is at least 20 mm",
"criterion": "longest diameter on general CT",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "mm"
}
}
]
}
]
},
{
"line": "4. ECOG PS 0 or 1",
"criterions": [
{
"exact_snippets": "ECOG PS 0 or 1",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
]
}
]
},
{
"line": "5. There are tumor samples available for gene detection (EGFR / ALK / ros1) and PD-L1 immunohistochemistry (IHC) in the subjects, and the tumor samples should be obtained within 3 months before enrollment.",
"criterions": [
{
"exact_snippets": "tumor samples available for gene detection (EGFR / ALK / ros1)",
"criterion": "tumor samples for gene detection",
"requirements": [
{
"requirement_type": "availability",
"expected_value": true
},
{
"requirement_type": "genes",
"expected_value": [
"EGFR",
"ALK",
"ros1"
]
}
]
},
{
"exact_snippets": "tumor samples available for ... PD-L1 immunohistochemistry (IHC)",
"criterion": "tumor samples for PD-L1 IHC",
"requirements": [
{
"requirement_type": "availability",
"expected_value": true
}
]
},
{
"exact_snippets": "tumor samples should be obtained within 3 months before enrollment",
"criterion": "tumor sample collection timing",
"requirements": [
{
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "6. If all suspected mediastinal lymph nodes (including those with pathological enlargement or FDG concentration on PET / CT) can be examined by EBUS, thoracoscopy or mediastinoscopy, further sampling is required for pathological confirmation.",
"criterions": [
{
"exact_snippets": "suspected mediastinal lymph nodes (including those with pathological enlargement or FDG concentration on PET / CT)",
"criterion": "mediastinal lymph nodes",
"requirements": [
{
"requirement_type": "suspicion",
"expected_value": true
},
{
"requirement_type": "pathological enlargement",
"expected_value": true
},
{
"requirement_type": "FDG concentration on PET / CT",
"expected_value": true
}
]
},
{
"exact_snippets": "can be examined by EBUS, thoracoscopy or mediastinoscopy",
"criterion": "examination method",
"requirements": [
{
"requirement_type": "methods",
"expected_value": [
"EBUS",
"thoracoscopy",
"mediastinoscopy"
]
}
]
}
]
},
{
"line": "7. Male or female, ≥ 18 years old",
"criterions": [
{
"exact_snippets": "Male or female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "≥ 18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "8. Adequate blood function: absolute neutrophil count (ANC) ≥ 2 × 109 / L, platelet count ≥ 100 × 109 / L and hemoglobin 110 ≥ 9 g / dl",
"criterions": [
{
"exact_snippets": "absolute neutrophil count (ANC) ≥ 2 × 109 / L",
"criterion": "absolute neutrophil count (ANC)",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "× 109 / L"
}
}
]
},
{
"exact_snippets": "platelet count ≥ 100 × 109 / L",
"criterion": "platelet count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "× 109 / L"
}
}
]
},
{
"exact_snippets": "hemoglobin 110 ≥ 9 g / dl",
"criterion": "hemoglobin",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 9,
"unit": "g / dl"
}
}
]
}
]
},
{
"line": "9. Adequate liver function: total bilirubin ≤ upper limit of normal value (ULN); AST and alt ≤ upper limit of normal value (ULN); alkaline phosphatase ≤ upper limit of normal value (ULN)",
"criterions": [
{
"exact_snippets": "total bilirubin ≤ upper limit of normal value (ULN)",
"criterion": "total bilirubin",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "ULN"
}
}
]
},
{
"exact_snippets": "AST and alt ≤ upper limit of normal value (ULN)",
"criterion": "AST and ALT",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "ULN"
}
}
]
},
{
"exact_snippets": "alkaline phosphatase ≤ upper limit of normal value (ULN)",
"criterion": "alkaline phosphatase",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "ULN"
}
}
]
}
]
},
{
"line": "10. Adequate renal function: serum creatinine ≤ upper limit of normal value (ULN) or calculated creatinine clearance ≥ 60ml / min",
"criterions": [
{
"exact_snippets": "Adequate renal function: serum creatinine ≤ upper limit of normal value (ULN)",
"criterion": "serum creatinine",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "ULN"
}
}
]
},
{
"exact_snippets": "calculated creatinine clearance ≥ 60ml / min",
"criterion": "creatinine clearance",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "ml/min"
}
}
]
}
]
},
{
"line": "11. No anti-tumor drug treatment in the past",
"criterions": [
{
"exact_snippets": "No anti-tumor drug treatment in the past",
"criterion": "anti-tumor drug treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "12. For patients who have had previous surgery, it is required that more than 4 weeks have passed since the start of study treatment, and the patients have recovered",
"criterions": [
{
"exact_snippets": "patients who have had previous surgery",
"criterion": "previous surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "more than 4 weeks have passed since the start of study treatment",
"criterion": "time since surgery",
"requirements": [
{
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "patients have recovered",
"criterion": "recovery from surgery",
"requirements": [
{
"requirement_type": "status",
"expected_value": "recovered"
}
]
}
]
},
{
"line": "13. Women with a full uterus must have negative pregnancy test results within 28 days before entering the study (unless it is 24 months after amenorrhea). If the pregnancy test is more than 7 days from the first administration, a urine pregnancy test is required for verification (within 7 days before the first administration)",
"criterions": [
{
"exact_snippets": "Women with a full uterus",
"criterion": "uterus status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "full"
}
]
},
{
"exact_snippets": "negative pregnancy test results",
"criterion": "pregnancy test result",
"requirements": [
{
"requirement_type": "result",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "within 28 days before entering the study",
"criterion": "pregnancy test timing",
"requirements": [
{
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days before study entry"
}
}
]
},
{
"exact_snippets": "unless it is 24 months after amenorrhea",
"criterion": "time since amenorrhea",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 24,
"unit": "months"
}
}
]
},
{
"exact_snippets": "If the pregnancy test is more than 7 days from the first administration, a urine pregnancy test is required for verification (within 7 days before the first administration)",
"criterion": "pregnancy test verification",
"requirements": [
{
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days before first administration"
}
}
]
}
]
},
{
"line": "14. Sign the informed consent form (the informed consent form needs to be approved by the independent ethics committee, and the informed consent of the patient should be obtained before starting any substantive trial procedure)",
"criterions": [
{
"exact_snippets": "Sign the informed consent form",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Have other malignant tumors in the last 5 years",
"criterions": [
{
"exact_snippets": "Have other malignant tumors in the last 5 years",
"criterion": "malignant tumors",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "2. AST and / or ALT > 2.5 times of the upper limit of normal value (ULN), with alkaline phosphatase > 5 times of the upper limit of normal value (ULN)",
"criterions": [
{
"exact_snippets": "AST and / or ALT > 2.5 times of the upper limit of normal value (ULN)",
"criterion": "AST and/or ALT levels",
"requirements": [
{
"requirement_type": "comparison",
"expected_value": {
"operator": ">",
"value": 2.5,
"unit": "times ULN"
}
}
]
},
{
"exact_snippets": "alkaline phosphatase > 5 times of the upper limit of normal value (ULN)",
"criterion": "alkaline phosphatase levels",
"requirements": [
{
"requirement_type": "comparison",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "times ULN"
}
}
]
}
]
},
{
"line": "3. Previously received radiotherapy",
"criterions": [
{
"exact_snippets": "Previously received radiotherapy",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "previously received",
"expected_value": true
}
]
}
]
},
{
"line": "4. Previously used chemotherapy drugs, targeted and immunotherapy drugs (except bisphosphonates)",
"criterions": [
{
"exact_snippets": "Previously used chemotherapy drugs",
"criterion": "chemotherapy drugs",
"requirements": [
{
"requirement_type": "previous use",
"expected_value": true
}
]
},
{
"exact_snippets": "Previously used ... targeted ... drugs",
"criterion": "targeted drugs",
"requirements": [
{
"requirement_type": "previous use",
"expected_value": true
}
]
},
{
"exact_snippets": "Previously used ... immunotherapy drugs",
"criterion": "immunotherapy drugs",
"requirements": [
{
"requirement_type": "previous use",
"expected_value": true
}
]
},
{
"exact_snippets": "(except bisphosphonates)",
"criterion": "bisphosphonates",
"requirements": [
{
"requirement_type": "previous use",
"expected_value": false
}
]
}
]
},
{
"line": "5. There are any uncontrolled systemic diseases, including active infection, uncontrolled hypertension, diabetes, unstable angina, congestive heart failure, myocardial infarction (within 1 year before treatment), serious arrhythmia requiring drug treatment, liver, kidney and metabolic diseases",
"criterions": [
{
"exact_snippets": "uncontrolled systemic diseases",
"criterion": "systemic diseases",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
]
},
{
"exact_snippets": "active infection",
"criterion": "infection",
"requirements": [
{
"requirement_type": "activity status",
"expected_value": "active"
}
]
},
{
"exact_snippets": "uncontrolled hypertension",
"criterion": "hypertension",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
]
},
{
"exact_snippets": "diabetes",
"criterion": "diabetes",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "unstable angina",
"criterion": "angina",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "unstable"
}
]
},
{
"exact_snippets": "congestive heart failure",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "myocardial infarction (within 1 year before treatment)",
"criterion": "myocardial infarction",
"requirements": [
{
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "year"
}
}
]
},
{
"exact_snippets": "serious arrhythmia requiring drug treatment",
"criterion": "arrhythmia",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "serious"
},
{
"requirement_type": "treatment requirement",
"expected_value": "drug treatment"
}
]
},
{
"exact_snippets": "liver, kidney and metabolic diseases",
"criterion": "liver, kidney and metabolic diseases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "6. Women in pregnancy or lactation",
"criterions": [
{
"exact_snippets": "Women in pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "lactation",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "7. The patient (male or female) has the possibility of childbearing but is unwilling or does not take effective contraceptive measures",
"criterions": [
{
"exact_snippets": "The patient (male or female) has the possibility of childbearing",
"criterion": "possibility of childbearing",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "unwilling or does not take effective contraceptive measures",
"criterion": "use of effective contraceptive measures",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "8. Receive the experimental treatment of other clinical studies at the same time (in the treatment period of clinical studies)",
"criterions": [
{
"exact_snippets": "Receive the experimental treatment of other clinical studies at the same time",
"criterion": "experimental treatment of other clinical studies",
"requirements": [
{
"requirement_type": "concurrent treatment",
"expected_value": false
}
]
}
]
},
{
"line": "9. Known to be allergic to possible chemotherapy drugs",
"criterions": [
{
"exact_snippets": "Known to be allergic to possible chemotherapy drugs",
"criterion": "allergy to chemotherapy drugs",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "10. There is evidence of other diseases, neurological or metabolic dysfunction, abnormal physical examination or laboratory examination, and it is suspected that there may be a high risk of contraindications to the study drug or complications related to treatment",
"criterions": [
{
"exact_snippets": "evidence of other diseases",
"criterion": "other diseases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "neurological or metabolic dysfunction",
"criterion": "neurological dysfunction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "neurological or metabolic dysfunction",
"criterion": "metabolic dysfunction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "abnormal physical examination",
"criterion": "abnormal physical examination",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "abnormal ... laboratory examination",
"criterion": "abnormal laboratory examination",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}