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])
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])