Non-Small Cell Lung Carcinoma TNM clinical staging | ALK Rearrangement ALK Break Apart FISH Probe Kit Test
Item
histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc that carries an alk rearrangement as determined locally by vysis alk break apart fish probe kit (abbott molecular inc.) test.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C4068350 (UMLS CUI [2,1])
C3831569 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
Non-Small Cell Lung Carcinoma Progression
Item
patients must have nsclc that has progressed at study enrollment.
boolean
C0007131 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Prior Therapy Non-Small Cell Lung Carcinoma Advanced Locally | Prior Therapy Non-small cell lung cancer metastatic | alectinib
Item
patients must have received previous treatment with alectinib for treatment of locally advanced or metastatic nsclc
boolean
C1514463 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1517927 (UMLS CUI [1,4])
C1514463 (UMLS CUI [2,1])
C0278987 (UMLS CUI [2,2])
C3853921 (UMLS CUI [3])
Chemotherapy Absent | Cytotoxic Chemotherapy Singular
Item
patients must be chemotherapy-naïve or have received only one line of prior cytotoxic chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0677881 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Age
Item
age 18 years or older at the time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Hypersensitivity LDK378 Excipient
Item
patients with known hypersensitivity to any of the excipients of ldk378.
boolean
C0020517 (UMLS CUI [1,1])
C3852624 (UMLS CUI [1,2])
C0015237 (UMLS CUI [1,3])
Prior Therapy | crizotinib | ALK Inhibitor | Investigational New Drugs Except Alectinib
Item
patients with prior treatment with crizotinib, or any other alk inhibitor investigational agents other than alectinib.
boolean
C1514463 (UMLS CUI [1])
C2974289 (UMLS CUI [2])
C1332080 (UMLS CUI [3,1])
C1999216 (UMLS CUI [3,2])
C0013230 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C3853921 (UMLS CUI [4,3])
Cancer treatment Systemic | Therapy, Investigational | Cytotoxic Chemotherapy Non-Small Cell Lung Carcinoma Advanced Locally | Cytotoxic Chemotherapy Non-small cell lung cancer metastatic
Item
prior systemic anti-cancer (including investigational) therapy aside from alectinib and one regimen of previous cytotoxic chemotherapy for locally advanced or metastatic nsclc.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2])
C0677881 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
C0205179 (UMLS CUI [3,3])
C1517927 (UMLS CUI [3,4])
C0677881 (UMLS CUI [4,1])
C0278987 (UMLS CUI [4,2])
CNS metastases Symptomatic | Patient Neurologic Unstable | Patient need for Steroids Increasing | Management CNS symptom
Item
patients with symptomatic central nervous system (cns) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage cns symptoms.
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0205494 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C0442808 (UMLS CUI [3,3])
C0376636 (UMLS CUI [4,1])
C0422879 (UMLS CUI [4,2])
Lung Disease, Interstitial | Pneumonia, Interstitial | Radiation Pneumonitis
Item
patient with history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
boolean
C0206062 (UMLS CUI [1])
C0206061 (UMLS CUI [2])
C0206063 (UMLS CUI [3])
Meningeal Carcinomatosis
Item
ptients with history of carcinomatous meningitis.
boolean
C0220654 (UMLS CUI [1])
Second Cancer | Malignant disease Except NSCLC | Treatment required for Second Cancer | Treatment required for Malignant disease
Item
patient with a concurrent malignancy or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years.
boolean
C0751623 (UMLS CUI [1])
C0442867 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
C0332121 (UMLS CUI [3,1])
C0751623 (UMLS CUI [3,2])
C0332121 (UMLS CUI [4,1])
C0442867 (UMLS CUI [4,2])
Heart Disease Uncontrolled | Cardiac event Recent
Item
patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0741923 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])