Non-Small Cell Lung Carcinoma Inoperable | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Secondary malignant neoplasm of lymph node Supraclavicular | Pleural Effusion, Malignant | Malignant pericardial effusion | Non-small cell lung cancer metastatic TNM clinical staging | Non-small cell lung cancer recurrent | Mixed Neoplasm
Item
1. histologically or cytologically documented inoperable, locally advanced (stage iiib with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage iv) or recurrent nsclc. mixed tumors should be categorized according to the predominant cell type.
boolean
C0007131 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C0686619 (UMLS CUI [3,1])
C1550301 (UMLS CUI [3,2])
C0080032 (UMLS CUI [4])
C0220655 (UMLS CUI [5])
C0278987 (UMLS CUI [6,1])
C3258246 (UMLS CUI [6,2])
C0278517 (UMLS CUI [7])
C1368354 (UMLS CUI [8])
Age
Item
2. age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
3. life expectancy more than 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Measurable lesion Linear Quantity
Item
5. at least one unidimensional measurable lesion (as per recist criteria)
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Bone Marrow function | Liver function | Renal function
Item
6. adequate baseline bone marrow, hepatic and renal function, defined as follows:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Neutrophil count | Platelet Count measurement
Item
neutrophils >1.5 x 10^9/l and platelets > 100 x 10^9/l
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin <1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent
Item
ast and/or alt <2.5 x uln in absence of liver metastasis
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Present
Item
ast and/or alt <5 x uln in presence of liver metastasis
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
Creatinine measurement, serum
Item
serum creatinine <1.5 x uln
boolean
C0201976 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance (estimated according to cockcroft-gault formula) ≥ 50 ml/min
boolean
C2711451 (UMLS CUI [1])
Prior Therapy
Item
7. patients may have had prior therapy providing the following conditions are met:
boolean
C1514463 (UMLS CUI [1])
Therapeutic radiology procedure | Washout Period
Item
radiation therapy: wash-out period of 28 days
boolean
C1522449 (UMLS CUI [1])
C1710661 (UMLS CUI [2])
Operative Surgical Procedures | Washout Period
Item
surgery: wash-out period of 14 days
boolean
C0543467 (UMLS CUI [1])
C1710661 (UMLS CUI [2])
Informed Consent
Item
8. patients must give written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Prior Chemotherapy | Antineoplastic Agents Systemic | Monoclonal antibodies, antineoplastic | Tyrosine kinase inhibitor
Item
1. prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor).
boolean
C1514457 (UMLS CUI [1])
C0003392 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C3542957 (UMLS CUI [3])
C1268567 (UMLS CUI [4])
Investigational New Drugs
Item
2. patients must not receive any other investigational agents while on study
boolean
C0013230 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations
Item
3. patients with myocardial infarction within the last six (6) months, unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C1514873 (UMLS CUI [4,3])
C0013227 (UMLS CUI [4,4])
Uncontrolled hypertension
Item
4. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Prolonged QTc interval Congenital | Prolonged QTc interval Acquired
Item
5. prolonged qtc interval (congenital or acquired)
boolean
C1560305 (UMLS CUI [1,1])
C1744681 (UMLS CUI [1,2])
C1560305 (UMLS CUI [2,1])
C0439661 (UMLS CUI [2,2])
Peripheral Vascular Disease
Item
6. patient with significant peripheral vascular disease
boolean
C0085096 (UMLS CUI [1])
CNS disorder Physical Examination | Exception CNS disorder Treated | Brain Tumor, Primary | Metastatic malignant neoplasm to brain | Standard therapy Absent Seizure | Cerebrovascular accident
Item
7. history or evidence upon physical examination of cns disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke).
boolean
C0007682 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007682 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0750974 (UMLS CUI [3])
C0220650 (UMLS CUI [4])
C2936643 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0036572 (UMLS CUI [5,3])
C0038454 (UMLS CUI [6])
Systemic disease | Sepsis | Systemic disease Uncontrolled | Sepsis Uncontrolled | Illness Serious Inconsistent Study Protocol | Medical condition Serious Inconsistent Study Protocol
Item
8. patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
boolean
C0442893 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
C0442893 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0243026 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0221423 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0442809 (UMLS CUI [5,3])
C2348563 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0442809 (UMLS CUI [6,3])
C2348563 (UMLS CUI [6,4])
Allergic Reaction Albumin Human | Hypersensitivity Albumin Human | Medical contraindication Albumin Human | Allergic Reaction Albumin Human Excipient | Hypersensitivity Albumin Human Excipient | Medical contraindication Albumin Human Excipient
Item
9. known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
boolean
C1527304 (UMLS CUI [1,1])
C0304925 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304925 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0304925 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0304925 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0304925 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C1301624 (UMLS CUI [6,1])
C0304925 (UMLS CUI [6,2])
C0015237 (UMLS CUI [6,3])
Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance
Item
10. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods | Menopausal Status Duration | Female Sterilization Absent | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
11. pregnancy or lactation. patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1513126 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0430061 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])