ID

36676

Description

LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.; ODM derived from: https://clinicaltrials.gov/show/NCT02450903

Link

https://clinicaltrials.gov/show/NCT02450903

Keywords

Versions (1)
  1. 5/31/19 5/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Cancer NCT02450903

English

Eligibility Non-Small-Cell Lung Cancer NCT02450903

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | ALK Rearrangement ALK Break Apart FISH Probe Kit Test

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C4068350
UMLS CUI [2,2]
C3831569
UMLS CUI [2,3]
C0022885
patients must have nsclc that has progressed at study enrollment.
Description

Non-Small Cell Lung Carcinoma Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0242656
patients must have received previous treatment with alectinib for treatment of locally advanced or metastatic nsclc
Description

Prior Therapy Non-Small Cell Lung Carcinoma Advanced Locally | Prior Therapy Non-small cell lung cancer metastatic | alectinib

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205179
UMLS CUI [1,4]
C1517927
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0278987
UMLS CUI [3]
C3853921
patients must be chemotherapy-naïve or have received only one line of prior cytotoxic chemotherapy.
Description

Chemotherapy Absent | Cytotoxic Chemotherapy Singular

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C0205171
age 18 years or older at the time of informed consent.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with known hypersensitivity to any of the excipients of ldk378.
Description

Hypersensitivity LDK378 Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3852624
UMLS CUI [1,3]
C0015237
patients with prior treatment with crizotinib, or any other alk inhibitor investigational agents other than alectinib.
Description

Prior Therapy | crizotinib | ALK Inhibitor | Investigational New Drugs Except Alectinib

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C2974289
UMLS CUI [3,1]
C1332080
UMLS CUI [3,2]
C1999216
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C0332300
UMLS CUI [4,3]
C3853921
prior systemic anti-cancer (including investigational) therapy aside from alectinib and one regimen of previous cytotoxic chemotherapy for locally advanced or metastatic nsclc.
Description

Cancer treatment Systemic | Therapy, Investigational | Cytotoxic Chemotherapy Non-Small Cell Lung Carcinoma Advanced Locally | Cytotoxic Chemotherapy Non-small cell lung cancer metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0949266
UMLS CUI [3,1]
C0677881
UMLS CUI [3,2]
C0007131
UMLS CUI [3,3]
C0205179
UMLS CUI [3,4]
C1517927
UMLS CUI [4,1]
C0677881
UMLS CUI [4,2]
C0278987
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.
Description

CNS metastases Symptomatic | Patient Neurologic Unstable | Patient need for Steroids Increasing | Management CNS symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0205494
UMLS CUI [2,3]
C0443343
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0038317
UMLS CUI [3,3]
C0442808
UMLS CUI [4,1]
C0376636
UMLS CUI [4,2]
C0422879
patient with history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
Description

Lung Disease, Interstitial | Pneumonia, Interstitial | Radiation Pneumonitis

Data type

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C0206061
UMLS CUI [3]
C0206063
ptients with history of carcinomatous meningitis.
Description

Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0220654
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.
Description

Second Cancer | Malignant disease Except NSCLC | Treatment required for Second Cancer | Treatment required for Malignant disease

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C0442867
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0007131
UMLS CUI [3,1]
C0332121
UMLS CUI [3,2]
C0751623
UMLS CUI [4,1]
C0332121
UMLS CUI [4,2]
C0442867
patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)
Description

Heart Disease Uncontrolled | Cardiac event Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0741923
UMLS CUI [2,2]
C0332185
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Non-Small-Cell Lung Cancer NCT02450903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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