Study to Evaluate Concordance of Detecting EGFR (Epidermal Growth Factor Receptor) Mutation by Circulating Tumour Free DNA Versus Tissues Biopsy in NSCLC (Non-small Cell Lung Cancer).

NSCLC (Non-small Cell Lung Cancer) Clinical Trial

— CONCORDANCE  

Official title:

An Observational, Multicentre, Prospective Study to Evaluate Concordance of Detecting EGFR (Epidermal Growth Factor Receptor) Mutation by Circulating Tumour Free DNA Versus Tissues Biopsy in NSCLC (Non-small Cell Lung Cancer).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562819
• Other study ID #: D5161R00003
• Status: Completed
• Start date: August 16, 2018
• Est. completion date: June 7, 2019

Study information

• Verified date: June 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multicentre, prospective, study of EGFR )Epidermal Growth Factor Receptor) mutation status in advanced NSCLC (Non-small cell lung cancer)patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 268 patients over a period of 6 months.

Description:

This is a multicentre, prospective, study of EGFR mutation status in advanced NSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 268 patients over a period of 6 months. The study will enroll patients with histologically confirmed, systemic treatment naïve adenocarcinoma metastatic cancer (stage IV). This will be a single visit study. No study medication will be prescribed or administered as a part of study procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients who provide written informed consent

2. Patients aged 18 years and older

3. Newly diagnosed patients with Metastatic (stage IV) NSCLC.

4. Histologically confirmed Adenocarcinoma NSCLC patient as per tissue biopsy and Tissue sample sent for EGFR mutation analysis OR result for EGFR mutation test is available from last 28 days from the date of enrolment.

5. Patient should be naïve for any systemic treatment (i.e. no chemotherapy or EGFR-TKI)

Exclusion Criteria:

1. Patient with any medical condition that, in the opinion of the investigator, would interfere with outcome of the study

2. Patient participating in any other interventional clinical study/trial.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• NSCLC (Non-small Cell Lung Cancer)

Locations

Country	Name	City	State
India	Research Site	Bengaluru	Karnataka
India	Research Site	Bhubaneswar	Odisha
India	Research Site	Hyderabad	Telanagana
India	Research Site	Kerala	Kozhikode
India	Research Site	Kolkata	West Bangal
India	Research Site	Kolkata	West Bengal
India	Research Site	Kolkata	West Bengal
India	Research Site	Maharashtra	Mumbai
India	Research Site	Mumbai	Maharashtra
India	Research Site	Mumbai	Maharashtra
India	Research Site	New Delhi	Delhi
India	Research Site	New Delhi	Delhi
India	Research Site	New Delhi	Delhi
India	Reserch Site	Punjab	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the level of concordance between EGFR mutation status	by tissue and plasma based testing in terms of Overall Concordance, Sensitivity, specificity, Positive predictive value & negative predictive value.	1 Day
Secondary	Assess the frequency of T790M mutation among study patients.	Frequency and percentage of TKI treatment naïve NSCLC patients with T790M mutation will be provided.	1 Day

External Links

•   Related Info