age at least 18 Years
Item
Alter mindestens 18Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Has histologically or cytologically confirmed squamous NSCLC.
Item
Has histologically or cytologically confirmed squamous NSCLC.
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C1182670 (UMLS CUI 2011AA)
C0007131 (UMLS CUI 2011AA)
254637007 (SNOMED CT 2011_0131)
10061873 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Has Stage IV disease at the time of study entry.
Item
Has Stage IV disease at the time of study entry.
boolean
C0441772 (UMLS CUI 2011AA)
258228008 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Measurable or nonmeasurable disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) (patients with only truly nonmeasurable disease are not eligible).
Item
Measurable or nonmeasurable disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) (patients with only truly nonmeasurable disease are not eligible).
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C1709926 (UMLS CUI 2011AA)
Has resolution to Grade <= 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia).
Item
Has resolution to Grade <= 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia).
boolean
C1514893 (UMLS CUI 2011AA)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
C0600688 (UMLS CUI 2011AA)
75478009 (SNOMED CT 2011_0131)
C1514457 (UMLS CUI 2011AA)
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
CL414551 (UMLS CUI 2011AA)
C1514460 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0002170 (UMLS CUI 2011AA)
56317004 (SNOMED CT 2011_0131)
10001760 (MedDRA 14.1)
L65.9 (ICD-10-CM Version 2010)
704.00 (ICD-9-CM Version 2011)
E13611 (CTCAE 1105E)
Has adequate hepatic function
Item
Has adequate hepatic function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
Has adequate renal function
Item
Has adequate renal function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
Has adequate hematologic function
Item
Has adequate hematologic function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0221130 (UMLS CUI 2011AA)
86084001 (SNOMED CT 2011_0131)
If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate < 1%) during and for 6 months after the treatment period (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method).
Item
If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate < 1%) during and for 6 months after the treatment period (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method).
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
CL424941 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C1947911 (UMLS CUI 2011AA)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
If male, the patient is surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period.
Item
If male, the patient is surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
Item
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Has archived tumor tissue available for analysis of EGFR and KRAS mutation status (by PCR) and EGFR gene copy number (by FISH). Minimum of four slides, paraffin-embedded tissue, required.
Item
Has archived tumor tissue available for analysis of EGFR and KRAS mutation status (by PCR) and EGFR gene copy number (by FISH). Minimum of four slides, paraffin-embedded tissue, required.
boolean
C0003738 (UMLS CUI 2011AA)
C0475358 (UMLS CUI 2011AA)
258435002 (SNOMED CT 2011_0131)
C0470187 (UMLS CUI 2011AA)
103328004 (SNOMED CT 2011_0131)
C0805997 (UMLS CUI 2011AA)
MTHU010096 (LOINC Version 232)
C2697836 (UMLS CUI 2011AA)
C0032520 (UMLS CUI 2011AA)
258066000 (SNOMED CT 2011_0131)
10050967 (MedDRA 14.1)
C1414313 (UMLS CUI 2011AA)
C1707513 (UMLS CUI 2011AA)
C0162789 (UMLS CUI 2011AA)
426329006 (SNOMED CT 2011_0131)
10066931 (MedDRA 14.1)
C1705201 (UMLS CUI 2011AA)
258661006 (SNOMED CT 2011_0131)
C0085185 (UMLS CUI 2011AA)
Has nonsquamous NSCLC (adenocarcinoma/large cell or other).
Item
Has nonsquamous NSCLC (adenocarcinoma/large cell or other).
boolean
C2585890 (UMLS CUI 2011AA)
440173001 (SNOMED CT 2011_0131)
C0152013 (UMLS CUI 2011AA)
254626006 (SNOMED CT 2011_0131)
10025031 (MedDRA 14.1)
C0345958 (UMLS CUI 2011AA)
254629004 (SNOMED CT 2011_0131)
10023774 (MedDRA 14.1)
Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.
Item
Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C1519313 (UMLS CUI 2011AA)
CL421608 (UMLS CUI 2011AA)
C0034802 (UMLS CUI 2011AA)
86960007 (SNOMED CT 2011_0131)
MTHU004296 (LOINC Version 232)
C1171892 (UMLS CUI 2011AA)
417324009 (SNOMED CT 2011_0131)
MTHU016264 (LOINC Version 232)
C0148199 (UMLS CUI 2011AA)
Has received previous chemotherapy for advanced NSCLC (patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 1 year prior to randomization).
Item
Has received previous chemotherapy for advanced NSCLC (patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 1 year prior to randomization).
boolean
C1514457 (UMLS CUI 2011AA)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
C0007131 (UMLS CUI 2011AA)
254637007 (SNOMED CT 2011_0131)
10061873 (MedDRA 14.1)
Has undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization.
Item
Has undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization.
boolean
C0679637 (UMLS CUI 2011AA)
C0949266 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (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)
C0034656 (UMLS CUI 2011AA)
Has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed).
Item
Has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed).
boolean
C0817096 (UMLS CUI 2011AA)
51185008 (SNOMED CT 2011_0131)
C1522449 (UMLS CUI 2011AA)
108290001 (SNOMED CT 2011_0131)
10037794 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL421682 (UMLS CUI 2011AA)
C0238792 (UMLS CUI 2011AA)
10061728 (MedDRA 14.1)
Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible.
Item
Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible.
boolean
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0549178 (UMLS CUI 2011AA)
C0149783 (UMLS CUI 2011AA)
297279009 (SNOMED CT 2011_0131)
10062117 (MedDRA 14.1)
C0039798 (UMLS CUI 2011AA)
C0003299 (UMLS CUI 2011AA)
255632006 (SNOMED CT 2011_0131)
MTHU006781 (LOINC Version 232)
Has superior vena cava syndrome contraindicating hydration.
Item
Has superior vena cava syndrome contraindicating hydration.
boolean
C0038833 (UMLS CUI 2011AA)
63363004 (SNOMED CT 2011_0131)
10042569 (MedDRA 14.1)
E13819 (CTCAE 1105E)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
CL034943 (UMLS CUI 2011AA)
Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure.
Item
Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure.
boolean
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
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)
Has experienced myocardial infarction within 6 months prior to randomization.
Item
Has experienced myocardial infarction within 6 months prior to randomization.
boolean
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)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus.
Item
Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus.
boolean
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0151332 (UMLS CUI 2011AA)
427099000 (SNOMED CT 2011_0131)
10071157 (MedDRA 14.1)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder.
Item
Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0455498 (UMLS CUI 2011AA)
161464003 (SNOMED CT 2011_0131)
C0497327 (UMLS CUI 2011AA)
52448006 (SNOMED CT 2011_0131)
10012267 (MedDRA 14.1)
F03 (ICD-10-CM Version 2010)
290 (ICD-9-CM Version 2011)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0005586 (UMLS CUI 2011AA)
13746004 (SNOMED CT 2011_0131)
10057667 (MedDRA 14.1)
MTHU026189 (LOINC Version 232)
F31 (ICD-10-CM Version 2010)
296.80 (ICD-9-CM Version 2011)
Has any NCI-CTCAE Version 3.0 Grade >= 2 peripheral neuropathy.
Item
Has any NCI-CTCAE Version 3.0 Grade >= 2 peripheral neuropathy.
boolean
C1557259 (UMLS CUI 2011AA)
MTHU113783 (CTCAE 1105E)
C1557260 (UMLS CUI 2011AA)
MTHU114803 (CTCAE 1105E)
C1557261 (UMLS CUI 2011AA)
MTHU115776 (CTCAE 1105E)
C1557262 (UMLS CUI 2011AA)
MTHU116556 (CTCAE 1105E)
C1557254 (UMLS CUI 2011AA)
MTHU113523 (CTCAE 1105E)
C1557255 (UMLS CUI 2011AA)
MTHU114539 (CTCAE 1105E)
C1557256 (UMLS CUI 2011AA)
MTHU115527 (CTCAE 1105E)
C1557257 (UMLS CUI 2011AA)
MTHU116371 (CTCAE 1105E)
Has significant third space fluid retention, requiring repeated drainage.
Item
Has significant third space fluid retention, requiring repeated drainage.
boolean
C0205437 (UMLS CUI 2011AA)
70905002 (SNOMED CT 2011_0131)
C0229984 (UMLS CUI 2011AA)
2969000 (SNOMED CT 2011_0131)
CL427986 (UMLS CUI 2011AA)
CL025467 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0205341 (UMLS CUI 2011AA)
27582007 (SNOMED CT 2011_0131)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
Has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the patient's ability to complete the study or sign an informed consent document.
Item
Has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the patient's ability to complete the study or sign an informed consent document.
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0809986 (UMLS CUI 2011AA)
C0449295 (UMLS CUI 2011AA)
246175000 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C2348583 (UMLS CUI 2011AA)
Has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab (IMC-11F8), or any other contraindication to one of the administered treatments.
Item
Has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab (IMC-11F8), or any other contraindication to one of the administered treatments.
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0039798 (UMLS CUI 2011AA)
C1705248 (UMLS CUI 2011AA)
CL414967 (UMLS CUI 2011AA)
C1705957 (UMLS CUI 2011AA)
C2352806 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
Is pregnant or breastfeeding.
Item
Is pregnant or breastfeeding.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Has a known history of drug abuse.
Item
History of substance abuse
boolean
C1299544 (UMLS CUI 2011AA)
371435006 (SNOMED CT 2011_0131)
Has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A patient with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for >= 3 years.
Item
Has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A patient with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for >= 3 years.
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (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)
CL411789 (UMLS CUI 2011AA)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (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)