ID

41169

Beschrijving

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT01933932

Link

https://clinicaltrials.gov/show/NCT01933932

Trefwoorden

Versies (1)
  1. 04-07-20 04-07-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 juli 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV NCT01933932

Engels

Eligibility Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV NCT01933932

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of signed, written and dated informed consent prior to any study specific procedures
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
male or female, aged 18 years or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histological or cytological confirmation of locally advanced or metastatic nsclc (iiib-iv)
Beschrijving

Locally Advanced Lung Non-Small Cell Carcinoma TNM clinical staging | Metastatic non-small cell lung cancer TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C5205550
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
kras mutation positive tumour sample as determined by the designated testing laboratory
Beschrijving

Tumor tissue sample KRAS Gene Mutation Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1517649
UMLS CUI [1,3]
C1514241
failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
Beschrijving

Cancer treatment First line Failed | Advanced disease | Recurrent disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0231175
UMLS CUI [2]
C0679246
UMLS CUI [3]
C0277556
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
mixed small cell and non-small cell lung cancer histology.
Beschrijving

Small cell carcinoma of lung Non-Small Cell Lung Carcinoma Mixed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0149925
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205430
received >1 prior anti-cancer drug regimen for advanced or metastatic nsclc. patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
Beschrijving

Cancer treatment Quantity Advanced Lung Non-Small Cell Carcinoma | Cancer treatment Quantity Metastatic non-small cell lung cancer | Disease Progression During Maintenance therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C5206378
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0278987
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C0677908
receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
Beschrijving

Cancer treatment Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
other concomitant anti-cancer therapy agents excepts steroids
Beschrijving

Antineoplastic Agents Except Steroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0038317
prior treatment with a mitogen-activated protein kinase (mek) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
Beschrijving

Prior Therapy | Mitogen-Activated Protein Kinase Inhibitor | docetaxel

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C1513344
UMLS CUI [3]
C0246415
last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
Beschrijving

Therapeutic radiology procedure Recent | Palliative course of radiotherapy Recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0475092
UMLS CUI [2,2]
C0332185
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Similar models

Eligibility Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV NCT01933932

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
provision of signed, written and dated informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female, aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Locally Advanced Lung Non-Small Cell Carcinoma TNM clinical staging | Metastatic non-small cell lung cancer TNM clinical staging
Item
histological or cytological confirmation of locally advanced or metastatic nsclc (iiib-iv)
boolean
C5205550 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Tumor tissue sample KRAS Gene Mutation Positive
Item
kras mutation positive tumour sample as determined by the designated testing laboratory
boolean
C0475358 (UMLS CUI [1,1])
C1517649 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Cancer treatment First line Failed | Advanced disease | Recurrent disease
Item
failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
boolean
C0920425 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0679246 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Small cell carcinoma of lung Non-Small Cell Lung Carcinoma Mixed
Item
mixed small cell and non-small cell lung cancer histology.
boolean
C0149925 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,3])
Cancer treatment Quantity Advanced Lung Non-Small Cell Carcinoma | Cancer treatment Quantity Metastatic non-small cell lung cancer | Disease Progression During Maintenance therapy
Item
received >1 prior anti-cancer drug regimen for advanced or metastatic nsclc. patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
boolean
C0920425 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C5206378 (UMLS CUI [1,3])
C0920425 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0278987 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C0677908 (UMLS CUI [3,3])
Cancer treatment Systemic
Item
receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Antineoplastic Agents Except Steroids
Item
other concomitant anti-cancer therapy agents excepts steroids
boolean
C0003392 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0038317 (UMLS CUI [1,3])
Prior Therapy | Mitogen-Activated Protein Kinase Inhibitor | docetaxel
Item
prior treatment with a mitogen-activated protein kinase (mek) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
boolean
C1514463 (UMLS CUI [1])
C1513344 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
Therapeutic radiology procedure Recent | Palliative course of radiotherapy Recent
Item
last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
boolean
C1522449 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0475092 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
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