Asia Pacific and Russia Diagnostic Study for EGFR Testing (IGNITE)

This study is currently recruiting participants.
Verified April 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01788163
First received: February 7, 2013
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

Interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. It will be conducted in Asia Pacific and Russia and will assess the current status of EGFR mutation testing, and the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA.


Condition Intervention
EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.
Genetic: EGFR mutation test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Diagnostic Study to Determine the Prevalence of EGFR Mutations in Asian and Russian Patients With Advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma Histologies

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Determination of EGFR mutation frequency (including mutation subtypes) in patients with advanced NSCLC (aNSCLC) of adenocarcinoma and non-adenocarcinoma histologies [ Time Frame: From randomization until study completion, assessed up to 17 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recording of first line therapy choice following EGFR mutation testing. [ Time Frame: From randomization until study completion, assessed up to 17 months ] [ Designated as safety issue: No ]
  • Recording of second line therapy choice following discontinuation of first line treatment for patients confirmed as EGFR mutation positive via tissue/cytology [ Time Frame: From randomization until study completion, assessed up to 17 months ] [ Designated as safety issue: No ]
  • Determination of the level of concordance between EGFR mutation status obtained via tissue/cytology and blood (plasma) based testing. [ Time Frame: From randomization until study completion, assessed up to 17 months ] [ Designated as safety issue: No ]
  • Summarise of EGFR mutation testing practices [ Time Frame: From randomization until study completion, assessed up to 17 months ] [ Designated as safety issue: No ]
    Summarise of EGFR mutation testing practices in terms of methods, sample types, success rate, mutation detection rate, testing turnaround time and reasons for testing not being performed.

  • Determination of the correlation between EGFR mutation status from tumour and demographic data and disease status [ Time Frame: From randomization until study completion, assessed up to 17 months ] [ Designated as safety issue: No ]
  • Determination of the correlation between EGFR mutation status derived from plasma (blood) and demographic data and disease status [ Time Frame: From randomization until study completion, assessed up to 17 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 3500
Study Start Date: February 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Locally advanced/metastatic NSCLC pats.
Patients with locally advanced (stage IIIA/B) or metastatic NSCLC who have not received any local or systemic chemotherapy, and are not eligible for curative treatment (including surgery and chemoradiotherapy)
Genetic: EGFR mutation test
EGFR mutation being tested in tissue and blood
Other Name: Determination of EGFR mutation done at the Pathology lab

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01788163

Contacts
Contact: Centraly founded study or local US study AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com
Contact: Esther Pascual +34 91 301 9224 esther.pascual@astrazeneca.com

  Show 75 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rose McCormack, PhD AstraZeneca, PHB
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01788163     History of Changes
Other Study ID Numbers: D7913C00074
Study First Received: February 7, 2013
Last Updated: April 7, 2014
Health Authority: Russia: Ethics Committee
China: Ethics Committee
Taiwan: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Indonesia: National Agency of Drug and Food Control
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Thailand: Ethical Committee
Malaysia: Ministry of Health
Australia: Human Research Ethics Committee

Keywords provided by AstraZeneca:
EGFR
aNSCLC
mutation status
diagnostic study
Russia
China
Asia

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasm Metastasis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014