A Diagnostic Study to Determine the Prevalence of EGFR Mutations in Asian and Russian Patients With Advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma Histologies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 3,500
- Locations
- 74
- Primary Endpoint
- Tumour EGFR Mutation Status by Histology
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
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.
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
- Plasma EGFR Mutation Testing(At Screening)
- Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples(At Screening)
- Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples(At Screening)
- Tumour EGFR Mutation Testing(At Screening)
- Plasma EGFR Mutation Testing Rates(At Screening)
- Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation(At Screening)
- Tumour EGFR Mutation Testing Turnaround Time(At Screening)
- Demographics and Disease Characteristics by Plasma EGFR Mutation Status(At Screening)
- First Line Treatment Choice by Asia Pacific Country(At Screening)
- Demographics and Disease Characteristics by Tumour EGFR Mutation Status(At Screening)
- Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples(At Screening)
- Tumour EGFR Mutation Testing Rates(At Screening)
- Number of Organs With Metastasis by Tumour EGFR Mutation Status(At Screening)
- Plasma EGFR Mutation Testing Turnaround Time(At Screening)
- Number of Organs With Metastasis by Plasma EGFR Mutation Status(At Screening)
- First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status(At Screening)
- Time Since First NSCLC Diagnosis by Plasma EGFR Mutation(At Screening)