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). (CONCORDANCE)

AstraZeneca

Status: Completed

Conditions: NSCLC (Non-small Cell Lung Cancer)

Study type: Observational

Funder types: Industry

Identifiers

NCT03562819

D5161R00003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 268 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

268 participants in 1 patient group

NSCLC

Description:

Non-small cell lung cancer