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

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

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.

Study Overview

• Status: Completed
• Conditions: EGFR Mutation Status in aNSCLC Patients
• Intervention / Treatment: Genetic: EGFR mutation test

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

• Study Type: Interventional
• Enrollment (Actual): 3500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Campbelltown, New South Wales, Australia
      • Research Site
    • Coffs Harbour, New South Wales, Australia
      • Research Site
    • Concord, New South Wales, Australia
      • Research Site
    • Tamworth, New South Wales, Australia
      • Research Site
    • Tweed Heads, New South Wales, Australia
      • Research Site
    • Wahroonga, New South Wales, Australia
      • Research Site
  • Queensland
    • Brisbane, Queensland, Australia
      • Research Site
    • Woolloongabba, Queensland, Australia
      • Research Site
  • Western Australia
    • Murdoch, Western Australia, Australia
      • Research Site
• China
  • Beijing, China
    • Research Site
  • Changsha, China
    • Research Site
  • Changzhou, China
    • Research Site
  • Chengdu, China
    • Research Site
  • Chengdu City, China
    • Research Site
  • Chongqing, China
    • Research Site
  • Foshan City, China
    • Research Site
  • Guangzhou, China
    • Research Site
  • Hangzhou, China
    • Research Site
  • Hangzhou City, China
    • Research Site
  • Nanjing, China
    • Research Site
  • Shanghai, China
    • Research Site
  • Suzhou City, China
    • Research Site
  • Taiyuan, China
    • Research Site
  • Wuhan City, China
    • Research Site
  • Zhengzhou, China
    • Research Site
• Indonesia
  • Jakarta, Indonesia
    • Research Site
  • Surabaya, Indonesia
    • Research Site
• Korea, Republic of
  • Cheongju, Korea, Republic of
    • Research Site
  • Daegu, Korea, Republic of
    • Research Site
  • Seoul, Korea, Republic of
    • Research Site
• Malaysia
  • Kuala Lumpur, Malaysia
    • Research Site
• Russian Federation
  • Arkhangelsk, Russian Federation
    • Research Site
  • Barnaul, Russian Federation
    • Research Site
  • Belgorod, Russian Federation
    • Research Site
  • Birobidzhan, Russian Federation
    • Research Site
  • Chelyabinsk, Russian Federation
    • Research Site
  • Chita, Russian Federation
    • Research Site
  • Irkutsk, Russian Federation
    • Research Site
  • Izhevsk, Russian Federation
    • Research Site
  • Kazan, Russian Federation
    • Research Site
  • Kemerovo, Russian Federation
    • Research Site
  • Khabarovsk, Russian Federation
    • Research Site
  • Khanty-Mansisk, Russian Federation
    • Research Site
  • Krasnodar, Russian Federation
    • Research Site
  • Krasnoyarsk, Russian Federation
    • Research Site
  • Lipetsk, Russian Federation
    • Research Site
  • Moscow, Russian Federation
    • Research Site
  • Novosibirsk, Russian Federation
    • Research Site
  • Obninsk, Russian Federation
    • Research Site
  • Omsk, Russian Federation
    • Research Site
  • Orel, Russian Federation
    • Research Site
  • Perm, Russian Federation
    • Research Site
  • Pyatigorsk, Russian Federation
    • Research Site
  • Rostov-on-Don, Russian Federation
    • Research Site
  • Ryazan, Russian Federation
    • Research Site
  • Samara, Russian Federation
    • Research Site
  • St. Petersburg, Russian Federation
    • Research Site
  • Surgut, Russian Federation
    • Research Site
  • Tula, Russian Federation
    • Research Site
  • Ufa, Russian Federation
    • Research Site
  • Velikiy Novgorod, Russian Federation
    • Research Site
  • Vladivostok, Russian Federation
    • Research Site
  • Volgograd, Russian Federation
    • Research Site
  • Yakutsk, Russian Federation
    • Research Site
  • Yaroslavl, Russian Federation
    • Research Site
  • Yuzhno-Sakhalinsk, Russian Federation
    • Research Site
• Singapore
  • Singapore, Singapore
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan
    • Research Site
  • Tainan, Taiwan
    • Research Site
  • Tainan City, Taiwan
    • Research Site
  • Taipei, Taiwan
    • Research Site
• Thailand
  • Chiang Mai, Thailand
    • Research Site
  • Khon Kaen, Thailand
    • Research Site
  • Patumwan Bangkok, Thailand
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Determination of EGFR mutation done at the Pathology lab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status	The 95% Confidence intervals were calculated using Clopper Pearson method for each country.	At Screening
Tumour EGFR Mutation by Subtype	Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.	At Screening
Tumour EGFR Mutation Status by Histology	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.	At Screening
Overall Plasma EGFR Mutation Status	Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.	At Screening
Plasma EGFR Mutation by Subtype	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.	At Screening
Plasma EGFR Mutation Status by Histology	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	At Screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples	Plasma samples were only performed in China, Taiwan, South Korea and Russia.	At Screening
Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples	Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed.	At Screening
Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples	Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed.	At Screening
Tumour EGFR Mutation Testing	Frequencies of tumour EGFR mutation testing practices parameters.	At Screening
Tumour EGFR Mutation Testing Rates	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.	At Screening
Tumour EGFR Mutation Testing Turnaround Time	Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.	At Screening
Plasma EGFR Mutation Testing	Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters.	At Screening
Plasma EGFR Mutation Testing Rates	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.	At Screening
Plasma EGFR Mutation Testing Turnaround Time	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.	At Screening
Demographics and Disease Characteristics by Tumour EGFR Mutation Status	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.	At Screening
Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation	Number of months since the first diagnosis of NSCLC from informed consent date.	At Screening
Number of Organs With Metastasis by Tumour EGFR Mutation Status	Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.	At Screening
Demographics and Disease Characteristics by Plasma EGFR Mutation Status	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.	At Screening
Time Since First NSCLC Diagnosis by Plasma EGFR Mutation	Number of months since the first diagnosis of NSCLC from informed consent date.	At Screening
Number of Organs With Metastasis by Plasma EGFR Mutation Status	Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.	At Screening
First Line Treatment Choice by Asia Pacific Country		At Screening
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status		At Screening

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Rose McCormack, PhD, AstraZeneca, PHB

Publications and helpful links

Helpful Links

• D7913C00074_CSR_Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2013
• Primary Completion (Actual): August 25, 2014
• Study Completion (Actual): June 20, 2016

Study Registration Dates

• First Submitted: February 7, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: China; EGFR; Russia; Asia; aNSCLC; mutation status; diagnostic study
• Other Study ID Numbers: D7913C00074