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Trial record 3 of 2671 for:    EGFR

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01788163
First Posted: February 11, 2013
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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 Genetic: EGFR mutation test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]
    The 95% Confidence intervals were calculated using Clopper Pearson method for each country.

  • Tumour EGFR Mutation by Subtype [ Time Frame: At Screening ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Frequencies of tumour EGFR mutation testing practices parameters.

  • Tumour EGFR Mutation Testing Rates [ Time Frame: At Screening ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status [ Time Frame: At Screening ]

Enrollment: 3500
Actual Study Start Date: February 27, 2013
Study Completion Date: June 20, 2016
Primary Completion Date: August 25, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 7, 2013
First Posted: February 11, 2013
Results First Submitted: October 30, 2015
Results First Posted: March 9, 2016
Last Update Posted: May 17, 2017
Last Verified: May 2017

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