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A Diagnostic Study to Determine the Prevalence of EGFR Mutations in Asian and Russian Patients With Advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma Histologies


Phase 4
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.

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Trial Information

A Diagnostic Study to Determine the Prevalence of EGFR Mutations in Asian and Russian Patients With Advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma Histologies


A diagnostic study to determine the prevalence of EGFR mutations in Asian and Russian
patients with advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma histologies


Inclusion Criteria:



- 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 Naive (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 (surgical
specimen, biopsy sample, or cytology sample is acceptable) and Provision of a routine
blood (plasma) sample in China, Russia, Taiwan and Korea

- Patients aged 18 years and older

Exclusion Criteria:

- As judged by the investigator, any evidence of severe or uncontrolled systemic
disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal
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:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determination of EGFR mutation frequency (including mutation subtypes) in patients with advanced NSCLC (aNSCLC) of adenocarcinoma and non-adenocarcinoma histologies

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, PHB

Authority:

Russia: Ethics Committee

Study ID:

D7913C00074

NCT ID:

NCT01788163

Start Date:

February 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
  • Russia
  • China
  • Asia
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasm Metastasis

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