age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib (Tarceva) or gefitinib (Iressa).
Item
Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib (Tarceva) or gefitinib (Iressa).
boolean
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0278984 (UMLS CUI 2011AA)
10029521 (MedDRA 14.1)
C0032227 (UMLS CUI 2011AA)
60046008 (SNOMED CT 2011_0131)
10035598 (MedDRA 14.1)
J90 (ICD-10-CM Version 2010)
511.9 (ICD-9-CM Version 2011)
E13486 (CTCAE 1105E)
C0031039 (UMLS CUI 2011AA)
373945007 (SNOMED CT 2011_0131)
10034474 (MedDRA 14.1)
E10172 (CTCAE 1105E)
C0278987 (UMLS CUI 2011AA)
10025055 (MedDRA 14.1)
C0162643 (UMLS CUI 2011AA)
10066901 (MedDRA 14.1)
C1135135 (UMLS CUI 2011AA)
414122006 (SNOMED CT 2011_0131)
C0910101 (UMLS CUI 2011AA)
426686007 (SNOMED CT 2011_0131)
C1122962 (UMLS CUI 2011AA)
398685009 (SNOMED CT 2011_0131)
Patients should have received and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s)) for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib
Item
Patients should have received and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s)) for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib
boolean
C0231175 (UMLS CUI 2011AA)
C0677881 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1514162 (UMLS CUI 2011AA)
CL031856 (UMLS CUI 2011AA)
C0210657 (UMLS CUI 2011AA)
411089001 (SNOMED CT 2011_0131)
Patients pretreated with taxane-based chemotherapy for advanced or metastatic disease must have experienced stable disease, partial or complete response as best response
Item
Patients pretreated with taxane-based chemotherapy for advanced or metastatic disease must have experienced stable disease, partial or complete response as best response
boolean
C1514457 (UMLS CUI 2011AA)
C0215136 (UMLS CUI 2011AA)
C1705938 (UMLS CUI 2011AA)
C0679246 (UMLS CUI 2011AA)
C0027627 (UMLS CUI 2011AA)
10027478 (MedDRA 14.1)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0677946 (UMLS CUI 2011AA)
C1521726 (UMLS CUI 2011AA)
103337004 (SNOMED CT 2011_0131)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
CL426196 (UMLS CUI 2011AA)
Eastern Cooperative Oncology Group performance Score 0 or 1.
Item
Eastern Cooperative Oncology Group performance Score 0 or 1.
boolean
C1520224 (UMLS CUI 2011AA)
Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as 20 mm or greater using conventional techniques or10 mm or greater with spiral CT scan according to RESIST 1.1.
Item
Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as 20 mm or greater using conventional techniques or10 mm or greater with spiral CT scan according to RESIST 1.1.
boolean
CL364385 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0040405 (UMLS CUI 2011AA)
77477000 (SNOMED CT 2011_0131)
10010234 (MedDRA 14.1)
0002 (HL7 V3 2006_05)
C0860888 (UMLS CUI 2011AA)
116152004 (SNOMED CT 2011_0131)
10041623 (MedDRA 14.1)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1709926 (UMLS CUI 2011AA)
Life expectancy of >= three (3) months.
Item
Life expectancy of >= three (3) months.
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Written informed consent that is consistent with ICH-GCP guidelines. Part B 1) Clinical benefit (disease stabilization or antitumor response) of 12 weeks duration in Part A of the trial determined on the second tumour assessment.
Item
Written informed consent that is consistent with ICH-GCP guidelines. Part B 1) Clinical benefit (disease stabilization or antitumor response) of 12 weeks duration in Part A of the trial determined on the second tumour assessment.
boolean
C0021430 (UMLS CUI 2011AA)
Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only)
Item
Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only)
boolean
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0279025 (UMLS CUI 2011AA)
309542002, 169413002 (SNOMED CT 2011_0131)
10065646 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0065879 (UMLS CUI 2011AA)
90357001 (SNOMED CT 2011_0131)
MTHU018761 (LOINC Version 232)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1268567 (UMLS CUI 2011AA)
372917005 (SNOMED CT 2011_0131)
C1882440 (UMLS CUI 2011AA)
Active brain metastases (stable <4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
Item
Active brain metastases (stable <4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0003299 (UMLS CUI 2011AA)
255632006 (SNOMED CT 2011_0131)
MTHU006781 (LOINC Version 232)
CL428853 (UMLS CUI 2011AA)
10070973 (MedDRA 14.1)
Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
Item
Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C0011991 (UMLS CUI 2011AA)
62315008 (SNOMED CT 2011_0131)
10012735 (MedDRA 14.1)
MTHU013347 (LOINC Version 232)
R19.7 (ICD-10-CM Version 2010)
787.91 (ICD-9-CM Version 2011)
E10572 (CTCAE 1105E)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0024523 (UMLS CUI 2011AA)
155841000 (SNOMED CT 2011_0131)
K90.4 (ICD-10-CM Version 2010)
C1559310 (UMLS CUI 2011AA)
MTHU114261 (CTCAE 1105E)
C1559311 (UMLS CUI 2011AA)
MTHU115273 (CTCAE 1105E)
C1559312 (UMLS CUI 2011AA)
MTHU116177 (CTCAE 1105E)
Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
Item
Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
boolean
C2826244 (UMLS CUI 2011AA)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0460002 (UMLS CUI 2011AA)
91689009 (SNOMED CT 2011_0131)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C1113679 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0013175 (UMLS CUI 2011AA)
185922005 (SNOMED CT 2011_0131)
Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer)
Item
Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
Radiotherapy within the past 2 weeks prior to treatment with the trial drug
Item
Radiotherapy within the past 2 weeks prior to treatment with the trial drug
boolean
C0034619 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3
Item
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
Cardiac left ventricular function with resting ejection fraction of < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
Item
Cardiac left ventricular function with resting ejection fraction of < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C0017200 (UMLS CUI 2011AA)
C0521317 (UMLS CUI 2011AA)
404221001 (SNOMED CT 2011_0131)
10028211 (MedDRA 14.1)
C2243117 (UMLS CUI 2011AA)
QTc interval at or > 0.47 second
Item
QTc-Intervall
boolean
C0489625 (UMLS CUI 2011AA)
MTHU024527 (LOINC Version 232)
Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) at or > 400 mg/m2
Item
Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) at or > 400 mg/m2
boolean
C1514463 (UMLS CUI 2011AA)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
CL426125 (UMLS CUI 2011AA)
C0013089 (UMLS CUI 2011AA)
68444001 (SNOMED CT 2011_0131)
MTHU004184 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
Absolute neutrophil count (ANC) at or < 1500 / mm3
Item
Absolute Neutrophil Count
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
Platelet count at or < 100,000 / mm3
Item
Thrombozyten
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
Bilirubin at or > 1.5 mg / dL (>26 mol / L, SI unit equivalent)
Item
Bilirubin at or > 1.5 mg / dL (>26 mol / L, SI unit equivalent)
boolean
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C1705302 (UMLS CUI 2011AA)
CL415123 (UMLS CUI 2011AA)
Aspartate amino transferase (AST) or alanine amino transferase (ALT) at or > three times the upper limit of normal (if related to liver metastases at or > five times the upper limit of normal)
Item
Aspartate amino transferase (AST) or alanine amino transferase (ALT) at or > three times the upper limit of normal (if related to liver metastases at or > five times the upper limit of normal)
boolean
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0494165 (UMLS CUI 2011AA)
94381002 (SNOMED CT 2011_0131)
10027457 (MedDRA 14.1)
C78.7 (ICD-10-CM Version 2010)
197.7 (ICD-9-CM Version 2011)
Serum creatinine at or > 1.5 times the upper normal limit or calculated/measured creatinine clearance at or < 60 mL/min
Item
Serum creatinine at or > 1.5 times the upper normal limit or calculated/measured creatinine clearance at or < 60 mL/min
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
Item
Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0015671 (UMLS CUI 2011AA)
66839005 (SNOMED CT 2011_0131)
MTHU035601 (LOINC Version 232)
FTH (HL7 V3 2006_05)
C0008059 (UMLS CUI 2011AA)
67822003 (SNOMED CT 2011_0131)
CHILD (HL7 V3 2006_05)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Pregnancy or breast feeding
Item
Pregnancy or breast feeding
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Patients unable to comply with the protocol
Item
Patients unable to comply with the protocol
boolean
C1321605 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
Item
Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
Known or suspected active drug or alcohol abuse
Item
Known or suspected active drug or alcohol abuse
boolean
C0237123 (UMLS CUI 2011AA)
Interstitial lung disease (ILD)
Item
interstitielle Lungenerkrankung
boolean
C1869044 (UMLS CUI 2011AA)
20000042 (MedDRA 14.1)
Peripheral polyneuropathy Grade >= 2
Item
Peripheral polyneuropathy Grade >= 2
boolean
C2673754 (UMLS CUI 2011AA)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)