Information:
Fel:
ID
34429
Beskrivning
LDK378 in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib; ODM derived from: https://clinicaltrials.gov/show/NCT02040870
Länk
https://clinicaltrials.gov/show/NCT02040870
Nyckelord
Versioner (1)
- 2019-01-17 2019-01-17 -
Rättsinnehavare
see on clinicaltrials.gov
Uppladdad den
17 januari 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02040870
Eligibility Non-Small Cell Lung Cancer NCT02040870
- StudyEvent: Eligibility
Similar models
Eligibility Non-Small Cell Lung Cancer NCT02040870
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
ID.1
Item
histologically or cytologically confirmed diagnosis of nsclc that carries an alk rearrangement defined as positive using the fda approved vysis alk break apart fish probe kit (abbott molecular inc.) test and scoring algorithm (including positivity criteria) or positive as assessed by the cfda approved immunohistochemistry (ihc) test (ventana medical systems, inc)
boolean
ID.2
Item
age 18 years or older at the time of informed consent.
boolean
ID.3
Item
patients must have stage iiib or iv nsclc at the time of study entry and have had progressive disease during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy. if treated with chemotherapy, maximum 2 lines are allowed.
boolean
ID.4
Item
patients with known hypersensitivity to any of the excipients of ldk378
boolean
ID.5
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
ID.6
Item
history of carcinomatous meningitis
boolean
ID.7
Item
presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years.
boolean
ID.8
Item
clinically significant, uncontrolled heart disease.
boolean