ID

4367

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00982111

Link

http://clinicaltrials.gov/show/NCT00982111

Stichworte

Versionen (2)
  1. 07.12.13 07.12.13 - Martin Dugas
  2. 17.09.21 17.09.21 -
Hochgeladen am

7. Dezember 2013

DOI

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Lizenz

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Eligibility NCT00982111 Non Small Cell Lung Cancer

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschreibung

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Beschreibung

age at least 18 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell or other) non small cell lung cancer.
Beschreibung

Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell or other) non small cell lung cancer.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C2585890
SNOMED CT 2011_0131
440173001
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0152013
SNOMED CT 2011_0131
254626006
MedDRA 14.1
10025031
UMLS CUI 2011AA
C0345958
SNOMED CT 2011_0131
254629004
MedDRA 14.1
10023774
Has Stage IV disease at the time of study entry.
Beschreibung

Has Stage IV disease at the time of study entry.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0441772
SNOMED CT 2011_0131
258228008
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C2348558
Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria in Solid Tumors RECIST 1.0) at the time of study entry (patients with only truly nonmeasurable disease are not eligible).
Beschreibung

Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria in Solid Tumors RECIST 1.0) at the time of study entry (patients with only truly nonmeasurable disease are not eligible).

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C1709926
UMLS CUI 2011AA
C2348558
Has resolution to Grade <= 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia).
Beschreibung

Has resolution to Grade <= 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia).

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1514893
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
UMLS CUI 2011AA
C0600688
SNOMED CT 2011_0131
75478009
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
CL414551
UMLS CUI 2011AA
C1514460
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0002170
SNOMED CT 2011_0131
56317004
MedDRA 14.1
10001760
ICD-10-CM Version 2010
L65.9
ICD-9-CM Version 2011
704.00
CTCAE 1105E
E13611
Has an Eastern Cooperative Oncology Group performance status score of 0-2.
Beschreibung

Has an Eastern Cooperative Oncology Group performance status score of 0-2.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1828078
SNOMED CT 2011_0131
425389002
UMLS CUI 2011AA
C1827388
SNOMED CT 2011_0131
422512005
UMLS CUI 2011AA
C1828242
SNOMED CT 2011_0131
422894000
Has adequate hepatic function
Beschreibung

Has adequate hepatic function

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
Has adequate renal function
Beschreibung

Has adequate renal function

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
Has adequate hematologic function
Beschreibung

Has adequate hematologic function

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0221130
SNOMED CT 2011_0131
86084001
If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method 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). If male, the patients surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period.
Beschreibung

If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method 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). If male, the patients surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0021359
SNOMED CT 2011_0131
8619003
MedDRA 14.1
10021926
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0566588
SNOMED CT 2011_0131
289172004
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
CL424941
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
Female patients of childbearing potential must have a negative serum
Beschreibung

Female patients of childbearing potential must have a negative serum

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
CL415098
UMLS CUI 2011AA
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
Ausschlusskriterien
Beschreibung

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Has squamous non small cell lung cancer.
Beschreibung

Has squamous non small cell lung cancer.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1182670
UMLS CUI 2011AA
C0007131
SNOMED CT 2011_0131
254637007
MedDRA 14.1
10061873
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.
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0920425
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
49616005
UMLS CUI 2011AA
C1519313
UMLS CUI 2011AA
CL421608
UMLS CUI 2011AA
C0034802
SNOMED CT 2011_0131
86960007
LOINC Version 232
MTHU004296
UMLS CUI 2011AA
C1171892
SNOMED CT 2011_0131
417324009
LOINC Version 232
MTHU016264
UMLS CUI 2011AA
C0148199
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).
Beschreibung

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).

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C0205179
SNOMED CT 2011_0131
86005002
UMLS CUI 2011AA
C0007131
SNOMED CT 2011_0131
254637007
MedDRA 14.1
10061873
Undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization.
Beschreibung

Undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C0949266
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed).
Beschreibung

Undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed).

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0817096
SNOMED CT 2011_0131
51185008
UMLS CUI 2011AA
C1522449
SNOMED CT 2011_0131
108290001
MedDRA 14.1
10037794
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
CL421682
UMLS CUI 2011AA
C0238792
MedDRA 14.1
10061728
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.
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
C0149783
SNOMED CT 2011_0131
297279009
MedDRA 14.1
10062117
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0003299
SNOMED CT 2011_0131
255632006
LOINC Version 232
MTHU006781
Has superior vena cava syndrome contraindicating hydration.
Beschreibung

Has superior vena cava syndrome contraindicating hydration.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0038833
SNOMED CT 2011_0131
63363004
MedDRA 14.1
10042569
CTCAE 1105E
E13819
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
CL034943
Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure
Beschreibung

Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0010068
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
Has experienced myocardial infarction within 6 months prior to randomization.
Beschreibung

Has experienced myocardial infarction within 6 months prior to randomization.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus.
Beschreibung

Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0151332
SNOMED CT 2011_0131
427099000
MedDRA 14.1
10071157
UMLS CUI 2011AA
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance.
Beschreibung

Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance.

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
UMLS CUI 2011AA
C0455498
SNOMED CT 2011_0131
161464003
UMLS CUI 2011AA
C0497327
SNOMED CT 2011_0131
52448006
MedDRA 14.1
10012267
ICD-10-CM Version 2010
F03
ICD-9-CM Version 2011
290
UMLS CUI 2011AA
C0036572
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
UMLS CUI 2011AA
C0005586
SNOMED CT 2011_0131
13746004
MedDRA 14.1
10057667
LOINC Version 232
MTHU026189
ICD-10-CM Version 2010
F31
ICD-9-CM Version 2011
296.80
Has Grade >= 2 peripheral neuropathy.
Beschreibung

Has Grade >= 2 peripheral neuropathy.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0031117
MedDRA 14.1
10029331
ICD-10-CM Version 2010
G64
ICD-9-CM Version 2011
350-359.99
UMLS CUI 2011AA
C1522446
UMLS CUI 2011AA
C0450094
UMLS CUI 2011AA
C0547054
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
Has significant third space fluid retention, requiring repeated drainage.
Beschreibung

Has significant third space fluid retention, requiring repeated drainage.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205437
SNOMED CT 2011_0131
70905002
UMLS CUI 2011AA
C0229984
SNOMED CT 2011_0131
2969000
UMLS CUI 2011AA
CL427986
UMLS CUI 2011AA
CL025467
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205341
SNOMED CT 2011_0131
27582007
UMLS CUI 2011AA
C0013103
SNOMED CT 2011_0131
122462000
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.
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0809986
UMLS CUI 2011AA
C0449295
SNOMED CT 2011_0131
246175000
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C2348583
The patient has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of IMC-11F8, or any other contraindication to one of the administered treatments.
Beschreibung

The patient has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of IMC-11F8, or any other contraindication to one of the administered treatments.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
CL414967
UMLS CUI 2011AA
C1705957
UMLS CUI 2011AA
C2352806
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
Is pregnant or breastfeeding.
Beschreibung

Is pregnant or breastfeeding.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
History of substance abuse
Beschreibung

Has a known history of drug abuse.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1299544
SNOMED CT 2011_0131
371435006
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.
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell or other) non small cell lung cancer.
Item
Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell or other) non small cell lung cancer.
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C2585890 (UMLS CUI 2011AA)
440173001 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
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 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 (as defined by the Response Evaluation Criteria in Solid Tumors RECIST 1.0) at the time of study entry (patients with only truly nonmeasurable disease are not eligible).
Item
Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria in Solid Tumors RECIST 1.0) at the time of study entry (patients with only truly nonmeasurable disease are not eligible).
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C1709926 (UMLS CUI 2011AA)
C2348558 (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 an Eastern Cooperative Oncology Group performance status score of 0-2.
Item
Has an Eastern Cooperative Oncology Group performance status score of 0-2.
boolean
C1828078 (UMLS CUI 2011AA)
425389002 (SNOMED CT 2011_0131)
C1827388 (UMLS CUI 2011AA)
422512005 (SNOMED CT 2011_0131)
C1828242 (UMLS CUI 2011AA)
422894000 (SNOMED CT 2011_0131)
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 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). If male, the patients surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period.
Item
If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method 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). If male, the patients surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period.
boolean
C0015780 (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)
Female patients of childbearing potential must have a negative serum
Item
Female patients of childbearing potential must have a negative serum
boolean
C0015780 (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)
CL415098 (UMLS CUI 2011AA)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Has squamous non small cell lung cancer.
Item
Has squamous non small cell lung cancer.
boolean
C1182670 (UMLS CUI 2011AA)
C0007131 (UMLS CUI 2011AA)
254637007 (SNOMED CT 2011_0131)
10061873 (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)
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
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)
Undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization.
Item
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)
Undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed).
Item
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)
C0750536 (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
C0021311 (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, potentially precluding protocol compliance.
Item
Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance.
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 Grade >= 2 peripheral neuropathy.
Item
Has Grade >= 2 peripheral neuropathy.
boolean
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C1522446 (UMLS CUI 2011AA)
C0450094 (UMLS CUI 2011AA)
C0547054 (UMLS CUI 2011AA)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
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)
The patient has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of IMC-11F8, or any other contraindication to one of the administered treatments.
Item
The patient has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of 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)
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