ID

27478

Beschrijving

Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT00806819

Link

https://clinicaltrials.gov/show/NCT00806819

Trefwoorden

Versies (1)
  1. 15-11-17 15-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

15 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00806819

Engels

Eligibility Carcinoma, Non-Small-Cell Lung NCT00806819

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patient aged 18 years or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically or cytologically confirmed stage iiib, iv (according to ajcc) or recurrent non small cell lung cancer (nsclc) (non squamous histologies)
Beschrijving

Nonsquamous nonsmall cell neoplasm of lung TNM clinical staging | Nonsquamous nonsmall cell neoplasm of lung Recurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2585890
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C2585890
UMLS CUI [2,2]
C2945760
3. relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy).
Beschrijving

Recurrent disease Post First line Chemotherapy | First line Chemotherapy failed | Chemotherapy Additional Recurrent disease | Adjuvant therapy | Neoadjuvant Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C1708063
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1524062
UMLS CUI [3,3]
C0277556
UMLS CUI [4]
C0677850
UMLS CUI [5]
C0600558
4. at least one target tumor lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (mri) or computed tomography (ct) in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral ct.
Beschrijving

Tumor Target Lesion Quantity Without Therapeutic radiology procedure | Measurable lesion Dimension Quantity MRI | Measurable lesion Dimension Quantity CT | Measurable lesion Dimension Quantity Spiral CT

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332288
UMLS CUI [1,5]
C1522449
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0024485
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0439534
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0040405
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0439534
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0860888
5. life expectancy of at least three months.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
6. eastern cooperative oncology group (ecog) score of 0 or 1.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
7. patient has given written informed consent which must be consistent with the international conference on harmonization, good clinical practice (ich-gcp) and local legislation.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous therapy with other vascular endothelial growth factor (vegf) inhibitors (other than bevacizumab) or pemetrexed for treatment of nsclc
Beschrijving

Prior Therapy Non-Small Cell Lung Carcinoma | Vascular Endothelial Growth Factor Inhibitors | Exception bevacizumab | pemetrexed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0007131
UMLS CUI [2]
C2267120
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0796392
UMLS CUI [4]
C0210657
2. treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Therapy, Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0949266
3. chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for treatment of extremities) within the past four weeks prior to treatment with the trial drug, i.e., the minimum time elapsed since the last anticancer therapy and the first administration of bibf 1120 must be four weeks
Beschrijving

Chemotherapy | Hormone Therapy | Immunotherapy Monoclonal Antibodies | Tyrosine kinase inhibitor | Therapeutic radiology procedure | Exception Therapeutic procedure Extremities | BIBF 1120

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0003250
UMLS CUI [4]
C1268567
UMLS CUI [5]
C1522449
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0087111
UMLS CUI [6,3]
C0015385
UMLS CUI [7]
C1879771
4. inability to stop intake of nsaids (non steroidal anti inflammatory drugs) for several days
Beschrijving

NSAIDs Unable to discontinue

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1548265
5. active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants). dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation)
Beschrijving

Metastatic malignant neoplasm to brain | Therapeutic radiology procedure Inadequate | Metastatic malignant neoplasm to brain Symptomatic | Anticonvulsants Patient need for | Dexamethasone Dose Stable allowed

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C0003286
UMLS CUI [4,2]
C0686904
UMLS CUI [5,1]
C0011777
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
UMLS CUI [5,4]
C0683607
6. radiographic evidence of cavitary or necrotic tumors
Beschrijving

Tumor Cavity Radiography | Necrotic tumor Radiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1510420
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C1300818
UMLS CUI [2,2]
C0034571
7. centrally located tumors with radiographic evidence (ct or mri) of local invasion of major blood vessels
Beschrijving

Tumor Location Central | Local tumor invasion Blood Vessel Major CT | Local tumor invasion Blood Vessel Major MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0205099
UMLS CUI [2,1]
C1300092
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C0205164
UMLS CUI [2,4]
C0040405
UMLS CUI [3,1]
C1300092
UMLS CUI [3,2]
C0005847
UMLS CUI [3,3]
C0205164
UMLS CUI [3,4]
C0024485
8. history of clinically significant haemoptysis within the past 3 months
Beschrijving

Hemoptysis

Datatype

boolean

Alias
UMLS CUI [1]
C0019079
9. therapeutic anticoagulation
Beschrijving

Anticoagulation Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0003281
10. history of major thrombotic or clinically relevant major bleeding event in the past 6 months
Beschrijving

Thrombotic episode Major | Hemorrhage Major

Datatype

boolean

Alias
UMLS CUI [1,1]
C2674163
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0205164
11. significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months,
Beschrijving

Cardiovascular Diseases | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
12. inadequate kidney, liver, blood clotting function
Beschrijving

Abnormal renal function | Liver Dysfunction | Abnormal blood clotting

Datatype

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0086565
UMLS CUI [3]
C1846821
13. inadequate blood count
Beschrijving

Blood count abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C1535970
14. significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial
Beschrijving

Weight loss Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0750502
15. current peripheral neuropathy greater than or equal to common terminology criteria for adverse events (ctcae) grade 2 except due to trauma
Beschrijving

Peripheral Neuropathy CTCAE Grades | Exception Peripheral Neuropathy Due to Trauma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0031117
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C3714660
16. pre-existing ascites (abdominal fluid collection) and/or clinically significant pleural effusion ( fluid collection between the lung and chest wall)
Beschrijving

Ascites Pre-existing | Pleural effusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0032227
17. major injuries and/or surgery within the past ten days prior to start of study drug
Beschrijving

Major injury | Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0332677
UMLS CUI [2]
C0679637
18. incomplete wound healing
Beschrijving

Wound, non-healed

Datatype

boolean

Alias
UMLS CUI [1]
C0750433
19. active or chronic hepatitis c and/or b infection additional exclusion criteria apply
Beschrijving

Hepatitis C | Hepatitis B | Hepatitis C, Chronic | Hepatitis B, Chronic | Exclusion Criteria Additional

Datatype

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0524910
UMLS CUI [4]
C0524909
UMLS CUI [5,1]
C0680251
UMLS CUI [5,2]
C1524062
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00806819

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female patient aged 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Nonsquamous nonsmall cell neoplasm of lung TNM clinical staging | Nonsquamous nonsmall cell neoplasm of lung Recurrent
Item
2. histologically or cytologically confirmed stage iiib, iv (according to ajcc) or recurrent non small cell lung cancer (nsclc) (non squamous histologies)
boolean
C2585890 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C2585890 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
Recurrent disease Post First line Chemotherapy | First line Chemotherapy failed | Chemotherapy Additional Recurrent disease | Adjuvant therapy | Neoadjuvant Therapy
Item
3. relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy).
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1708063 (UMLS CUI [1,4])
C0392920 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C0277556 (UMLS CUI [3,3])
C0677850 (UMLS CUI [4])
C0600558 (UMLS CUI [5])
Tumor Target Lesion Quantity Without Therapeutic radiology procedure | Measurable lesion Dimension Quantity MRI | Measurable lesion Dimension Quantity CT | Measurable lesion Dimension Quantity Spiral CT
Item
4. at least one target tumor lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (mri) or computed tomography (ct) in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral ct.
boolean
C0027651 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332288 (UMLS CUI [1,4])
C1522449 (UMLS CUI [1,5])
C1513041 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
C1513041 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0040405 (UMLS CUI [3,4])
C1513041 (UMLS CUI [4,1])
C0439534 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0860888 (UMLS CUI [4,4])
Life Expectancy
Item
5. life expectancy of at least three months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
7. patient has given written informed consent which must be consistent with the international conference on harmonization, good clinical practice (ich-gcp) and local legislation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Non-Small Cell Lung Carcinoma | Vascular Endothelial Growth Factor Inhibitors | Exception bevacizumab | pemetrexed
Item
1. previous therapy with other vascular endothelial growth factor (vegf) inhibitors (other than bevacizumab) or pemetrexed for treatment of nsclc
boolean
C1514463 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C2267120 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0796392 (UMLS CUI [3,2])
C0210657 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs | Therapy, Investigational
Item
2. treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Chemotherapy | Hormone Therapy | Immunotherapy Monoclonal Antibodies | Tyrosine kinase inhibitor | Therapeutic radiology procedure | Exception Therapeutic procedure Extremities | BIBF 1120
Item
3. chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for treatment of extremities) within the past four weeks prior to treatment with the trial drug, i.e., the minimum time elapsed since the last anticancer therapy and the first administration of bibf 1120 must be four weeks
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3,1])
C0003250 (UMLS CUI [3,2])
C1268567 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0087111 (UMLS CUI [6,2])
C0015385 (UMLS CUI [6,3])
C1879771 (UMLS CUI [7])
NSAIDs Unable to discontinue
Item
4. inability to stop intake of nsaids (non steroidal anti inflammatory drugs) for several days
boolean
C0003211 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Therapeutic radiology procedure Inadequate | Metastatic malignant neoplasm to brain Symptomatic | Anticonvulsants Patient need for | Dexamethasone Dose Stable allowed
Item
5. active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants). dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation)
boolean
C0220650 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0003286 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
C0011777 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0683607 (UMLS CUI [5,4])
Tumor Cavity Radiography | Necrotic tumor Radiography
Item
6. radiographic evidence of cavitary or necrotic tumors
boolean
C0027651 (UMLS CUI [1,1])
C1510420 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C1300818 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
Tumor Location Central | Local tumor invasion Blood Vessel Major CT | Local tumor invasion Blood Vessel Major MRI
Item
7. centrally located tumors with radiographic evidence (ct or mri) of local invasion of major blood vessels
boolean
C0027651 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0205099 (UMLS CUI [1,3])
C1300092 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
C1300092 (UMLS CUI [3,1])
C0005847 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
Hemoptysis
Item
8. history of clinically significant haemoptysis within the past 3 months
boolean
C0019079 (UMLS CUI [1])
Anticoagulation Therapy
Item
9. therapeutic anticoagulation
boolean
C0003281 (UMLS CUI [1])
Thrombotic episode Major | Hemorrhage Major
Item
10. history of major thrombotic or clinically relevant major bleeding event in the past 6 months
boolean
C2674163 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
Cardiovascular Diseases | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction
Item
11. significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months,
boolean
C0007222 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Abnormal renal function | Liver Dysfunction | Abnormal blood clotting
Item
12. inadequate kidney, liver, blood clotting function
boolean
C0151746 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C1846821 (UMLS CUI [3])
Blood count abnormal
Item
13. inadequate blood count
boolean
C1535970 (UMLS CUI [1])
Weight loss Significant
Item
14. significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial
boolean
C1262477 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Peripheral Neuropathy CTCAE Grades | Exception Peripheral Neuropathy Due to Trauma
Item
15. current peripheral neuropathy greater than or equal to common terminology criteria for adverse events (ctcae) grade 2 except due to trauma
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0031117 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C3714660 (UMLS CUI [2,4])
Ascites Pre-existing | Pleural effusion
Item
16. pre-existing ascites (abdominal fluid collection) and/or clinically significant pleural effusion ( fluid collection between the lung and chest wall)
boolean
C0003962 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
Major injury | Major surgery
Item
17. major injuries and/or surgery within the past ten days prior to start of study drug
boolean
C0332677 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
Wound, non-healed
Item
18. incomplete wound healing
boolean
C0750433 (UMLS CUI [1])
Hepatitis C | Hepatitis B | Hepatitis C, Chronic | Hepatitis B, Chronic | Exclusion Criteria Additional
Item
19. active or chronic hepatitis c and/or b infection additional exclusion criteria apply
boolean
C0019196 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
C0524909 (UMLS CUI [4])
C0680251 (UMLS CUI [5,1])
C1524062 (UMLS CUI [5,2])
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