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).

AstraZeneca268 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

268

Conditions

NSCLC (Non-small Cell Lung Cancer)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (14)

Reserch Site

Punjab, Chandigarh, India

Research Site

Bengaluru, Karnataka, India

Research Site

Kerala, Kozhikode, India

Outcomes

Primary Outcomes

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.

Time frame: 1 Day

Secondary Outcomes

Assess the frequency of T790M mutation among study patients.

Frequency and percentage of TKI treatment naïve NSCLC patients with T790M mutation will be provided.

Time frame: 1 Day

Data from ClinicalTrials.gov

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