A Diagnostic Study of European and Japanese Advanced NSCLC Patients to Evaluate Suitable Sample Types for EGFR Testing,
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.
Both
EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.
Trial Information
A Diagnostic Study of European and Japanese Advanced NSCLC Patients to Evaluate Suitable Sample Types for EGFR Testing,
A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable
sample types for EGFR testing,
Inclusion Criteria:
- Patients aged 18 years and older in Europe and aged 20 years and older in Japan
- Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not
suitable for curative treatment or metastatic (stage IV) NSCLC.
- Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are
systemic treatment Naïve (i.e. no chemotherapy or EGFR-TKI) or patients with
recurrent disease who have previously received adjuvant chemotherapy (not including
EGFR-TKI)
- Provision of diagnostic cancer tissue or cytology sample upon inclusion
- Provision of a routine blood sample
Exclusion Criteria:
- Evidence of severe or uncontrolled systemic disease
- Evidence of any other significant clinical disorder or laboratory finding that made
it undesirable for the patient to participate in the study
- Pregnancy or breast-feeding
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Determination of the level of concordance between EGFR mutation status obtained via tissue/cytology and blood (plasma) based testing.
Outcome Time Frame:
From randomization until study completion, assessed up to 17 months
Safety Issue:
No
Principal Investigator
Rose McCormack, PhD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United Kingdom: National Health Service
Study ID:
D7913C00070
NCT ID:
NCT01785888
Start Date:
April 2013
Completion Date:
July 2014
Related Keywords:
- EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.
- EGFR,
- aNSCLC,
- mutation status,
- diagnostic study,
- Europe,
- Japan
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Neoplasm Metastasis
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