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Completed

NCT Number: NCT01788163

Asia Pacific and Russia Diagnostic Study for EGFR Testing

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.

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Key information

Conditions

EGFR Mutation Status in aNSCLC Patients Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Site, Campbelltown, New South Wales, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EGFR Mutation Test

Genetic

EGFR mutation being tested in tissue and blood

Other names: Determination of EGFR mutation done at the Pathology lab

Primary outcomes

  1. 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.

  2. Tumour EGFR Mutation by Subtype

    Time frame: At Screening

    Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.

  3. 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.

  4. 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.

  5. 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.

  6. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Tumour EGFR Mutation Testing

    Time frame: At Screening

    Frequencies of tumour EGFR mutation testing practices parameters.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. First Line Treatment Choice by Asia Pacific Country

    Time frame: At Screening

  17. First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status

    Time frame: At Screening

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: IGNITE

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Feb 11, 2013
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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