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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01788163
First received: February 7, 2013
Last updated: July 29, 2016
Last verified: July 2016
  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: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    The 95% Confidence intervals were calculated using Clopper Pearson method for each country.

  • Tumour EGFR Mutation by Subtype [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.

  • Tumour EGFR Mutation Status by Histology [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country.

  • Overall Plasma EGFR Mutation Status [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.

  • Plasma EGFR Mutation by Subtype [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.

  • Plasma EGFR Mutation Status by Histology [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country


Secondary Outcome Measures:
  • Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Plasma samples were only performed in China, Taiwan, South Korea and Russia.

  • Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed.

  • Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed.

  • Tumour EGFR Mutation Testing [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Frequencies of tumour EGFR mutation testing practices parameters.

  • Tumour EGFR Mutation Testing Rates [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation.

  • Tumour EGFR Mutation Testing Turnaround Time [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.

  • Plasma EGFR Mutation Testing [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters.

  • Plasma EGFR Mutation Testing Rates [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. Plasma samples were only performed in China, Taiwan, South Korea and Russia.

  • Plasma EGFR Mutation Testing Turnaround Time [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Plasma samples were only performed in China, Taiwan, South Korea and Russia. Plasma EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.

  • Demographics and Disease Characteristics by Tumour EGFR Mutation Status [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.

  • Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Number of months since the first diagnosis of NSCLC from informed consent date.

  • Number of Organs With Metastasis by Tumour EGFR Mutation Status [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.

  • Demographics and Disease Characteristics by Plasma EGFR Mutation Status [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.

  • Time Since First NSCLC Diagnosis by Plasma EGFR Mutation [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Number of months since the first diagnosis of NSCLC from informed consent date.

  • Number of Organs With Metastasis by Plasma EGFR Mutation Status [ Time Frame: At Screening ] [ Designated as safety issue: No ]
    Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.

  • First Line Treatment Choice by Asia Pacific Country [ Time Frame: At Screening ] [ Designated as safety issue: No ]
  • First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status [ Time Frame: At Screening ] [ Designated as safety issue: No ]

Enrollment: 3500
Study Start Date: February 2013
Study Completion Date: June 2016
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 74 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rose McCormack, PhD AstraZeneca, PHB
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01788163     History of Changes
Other Study ID Numbers: D7913C00074 
Study First Received: February 7, 2013
Results First Received: October 30, 2015
Last Updated: July 29, 2016
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 December 02, 2016