ID

14905

Beskrivning

Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02272413

Länk

https://clinicaltrials.gov/show/NCT02272413

Nyckelord

Versioner (1)
  1. 2016-05-06 2016-05-06 -
Uppladdad den

6 maj 2016

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02272413

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT02272413

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients aged >=18 years with histologically or cytologically confirmed advanced nonsquamous non-small cell lung cancer (nsnsclc). mixed tumors should be categorized according to the predominant histology.
Beskrivning

Nonsquamous nonsmall cell neoplasm of lung Advanced phase | Age | Adult | Malignant Mixed Tumor Histology Procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2585890
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0001675
UMLS CUI [4,1]
C0206625
UMLS CUI [4,2]
C0344441
note: nsclc should be predominantly nonsquamous. recurrent or metastatic disease (stage iv) with an indication for therapy with paclitaxel + carboplatin + avastin®.
Beskrivning

Non-Small Cell Lung Carcinoma | Recurrent disease | Neoplasm Metastasis Stage level 4 | Indication Therapeutic procedure Paclitaxel Carboplatin Avastin

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0441772
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0144576
UMLS CUI [4,4]
C0079083
UMLS CUI [4,5]
C1135130
patients harboring tumors with unknown or without activating epidermal growth factor receptor (egfr) / anaplastic lymphoma receptor tyrosine kinase (alk) mutation maybe included provided chemotherapy is standard of care. at least one measurable lesion according to response evaluation criteria in solid tumors (recist) 1.1 based on independent central review.
Beskrivning

Malignant Neoplasms | epidermal growth factor receptor activity | anaplastic lymphoma kinase Mutation | Chemotherapy Regimen | Measurable Disease Response Evaluation Criteria in Solid Tumors

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1150617
UMLS CUI [3,1]
C0252409
UMLS CUI [3,2]
C0026882
UMLS CUI [4]
C0392920
UMLS CUI [5,1]
C1513041
UMLS CUI [5,2]
C1709926
eastern cooperative oncology group (ecog) performance status (ps) 0 or 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hepatic, renal, and bone marrow function:
Beskrivning

Normal liver function | Normal renal function | Bone Marrow Function Adequate

Datatyp

boolean

Alias
UMLS CUI [1]
C1848676
UMLS CUI [2]
C0232805
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0542341
UMLS CUI [3,3]
C0205411
life expectancy > 6 months based on clinical judgment. further inclusion criteria apply.
Beskrivning

Life Expectancy Medical Diagnostic Clinical Judgment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0237512
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior therapy with monoclonal antibodies or small molecule inhibitors against vascular endothelial growth factor (vegf) or vegf receptors, including avastin®.
Beskrivning

Prior Therapy | Monoclonal Antibodies | Small Molecule inhibitors | Vascular Endothelial Growth Factor A | Vascular Endothelial Growth Factor Receptor | Avastin

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0003250
UMLS CUI [3,1]
C1328819
UMLS CUI [3,2]
C0243077
UMLS CUI [4]
C0078058
UMLS CUI [5]
C0148199
UMLS CUI [6]
C1135130
prior systemic therapy for metastatic disease. prior systemic anticancer therapy or radiotherapy for locally advanced nsnsclc if completed <12 months prior to screening.
Beskrivning

systemic therapy Neoplasm Metastasis | cancer treatment Systemic | Therapeutic radiology procedure | Nonsquamous nonsmall cell neoplasm of lung Advanced phase Locally

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C2585890
UMLS CUI [4,2]
C0205179
UMLS CUI [4,3]
C1517927
previous malignancy other than nsclc in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix.
Beskrivning

Malignant Neoplasms Previous | Non-Small Cell Lung Carcinoma | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0007131
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0851140
symptomatic brain metastasis. diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung, nsclc not specified (ns) or nsclc not otherwise specified(nos).
Beskrivning

Metastatic malignant neoplasm to brain Symptomatic | Small cell carcinoma of lung | Squamous cell carcinoma of lung | Non-Small Cell Lung Carcinoma Unspecified | Non-Small Cell Lung Carcinoma Not Otherwise Specified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0149925
UMLS CUI [3]
C0149782
UMLS CUI [4,1]
C0007131
UMLS CUI [4,2]
C0205370
UMLS CUI [5,1]
C0007131
UMLS CUI [5,2]
C1518425
any unresolved toxicity > common toxicity criteria grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy).
Beskrivning

Toxic effect Unresolved | Common Terminology Criteria for Adverse Events | Alopecia | cancer treatment Previous | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0443342
UMLS CUI [2]
C1516728
UMLS CUI [3]
C0002170
UMLS CUI [4,1]
C0920425
UMLS CUI [4,2]
C0205156
UMLS CUI [5]
C1522449
history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. thrombotic or hemorrhagic event =< 6 months prior to screening. further exclusion criteria apply.
Beskrivning

Congenital bleeding diathesis | hereditary coagulopathy | Bleeding Risk | Thrombosis | Hemorrhagic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C1856452
UMLS CUI [2]
C0679428
UMLS CUI [3]
C3251812
UMLS CUI [4]
C0040053
UMLS CUI [5]
C0019087
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02272413

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Nonsquamous nonsmall cell neoplasm of lung Advanced phase | Age | Adult | Malignant Mixed Tumor Histology Procedure
Item
adult patients aged >=18 years with histologically or cytologically confirmed advanced nonsquamous non-small cell lung cancer (nsnsclc). mixed tumors should be categorized according to the predominant histology.
boolean
C2585890 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0001675 (UMLS CUI [3])
C0206625 (UMLS CUI [4,1])
C0344441 (UMLS CUI [4,2])
Non-Small Cell Lung Carcinoma | Recurrent disease | Neoplasm Metastasis Stage level 4 | Indication Therapeutic procedure Paclitaxel Carboplatin Avastin
Item
note: nsclc should be predominantly nonsquamous. recurrent or metastatic disease (stage iv) with an indication for therapy with paclitaxel + carboplatin + avastin®.
boolean
C0007131 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C0441772 (UMLS CUI [3,2])
C3146298 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0144576 (UMLS CUI [4,3])
C0079083 (UMLS CUI [4,4])
C1135130 (UMLS CUI [4,5])
Malignant Neoplasms | epidermal growth factor receptor activity | anaplastic lymphoma kinase Mutation | Chemotherapy Regimen | Measurable Disease Response Evaluation Criteria in Solid Tumors
Item
patients harboring tumors with unknown or without activating epidermal growth factor receptor (egfr) / anaplastic lymphoma receptor tyrosine kinase (alk) mutation maybe included provided chemotherapy is standard of care. at least one measurable lesion according to response evaluation criteria in solid tumors (recist) 1.1 based on independent central review.
boolean
C0006826 (UMLS CUI [1])
C1150617 (UMLS CUI [2])
C0252409 (UMLS CUI [3,1])
C0026882 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4])
C1513041 (UMLS CUI [5,1])
C1709926 (UMLS CUI [5,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status (ps) 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Normal liver function | Normal renal function | Bone Marrow Function Adequate
Item
adequate hepatic, renal, and bone marrow function:
boolean
C1848676 (UMLS CUI [1])
C0232805 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0542341 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
Life Expectancy Medical Diagnostic Clinical Judgment
Item
life expectancy > 6 months based on clinical judgment. further inclusion criteria apply.
boolean
C0023671 (UMLS CUI [1,1])
C0237512 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy | Monoclonal Antibodies | Small Molecule inhibitors | Vascular Endothelial Growth Factor A | Vascular Endothelial Growth Factor Receptor | Avastin
Item
prior therapy with monoclonal antibodies or small molecule inhibitors against vascular endothelial growth factor (vegf) or vegf receptors, including avastin®.
boolean
C1514463 (UMLS CUI [1])
C0003250 (UMLS CUI [2])
C1328819 (UMLS CUI [3,1])
C0243077 (UMLS CUI [3,2])
C0078058 (UMLS CUI [4])
C0148199 (UMLS CUI [5])
C1135130 (UMLS CUI [6])
systemic therapy Neoplasm Metastasis | cancer treatment Systemic | Therapeutic radiology procedure | Nonsquamous nonsmall cell neoplasm of lung Advanced phase Locally
Item
prior systemic therapy for metastatic disease. prior systemic anticancer therapy or radiotherapy for locally advanced nsnsclc if completed <12 months prior to screening.
boolean
C1515119 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3])
C2585890 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C1517927 (UMLS CUI [4,3])
Malignant Neoplasms Previous | Non-Small Cell Lung Carcinoma | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
previous malignancy other than nsclc in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
Metastatic malignant neoplasm to brain Symptomatic | Small cell carcinoma of lung | Squamous cell carcinoma of lung | Non-Small Cell Lung Carcinoma Unspecified | Non-Small Cell Lung Carcinoma Not Otherwise Specified
Item
symptomatic brain metastasis. diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung, nsclc not specified (ns) or nsclc not otherwise specified(nos).
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0149925 (UMLS CUI [2])
C0149782 (UMLS CUI [3])
C0007131 (UMLS CUI [4,1])
C0205370 (UMLS CUI [4,2])
C0007131 (UMLS CUI [5,1])
C1518425 (UMLS CUI [5,2])
Toxic effect Unresolved | Common Terminology Criteria for Adverse Events | Alopecia | cancer treatment Previous | Therapeutic radiology procedure
Item
any unresolved toxicity > common toxicity criteria grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy).
boolean
C0600688 (UMLS CUI [1,1])
C0443342 (UMLS CUI [1,2])
C1516728 (UMLS CUI [2])
C0002170 (UMLS CUI [3])
C0920425 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5])
Congenital bleeding diathesis | hereditary coagulopathy | Bleeding Risk | Thrombosis | Hemorrhagic Disorders
Item
history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. thrombotic or hemorrhagic event =< 6 months prior to screening. further exclusion criteria apply.
boolean
C1856452 (UMLS CUI [1])
C0679428 (UMLS CUI [2])
C3251812 (UMLS CUI [3])
C0040053 (UMLS CUI [4])
C0019087 (UMLS CUI [5])
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