Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced NSCLC Patients

Institut Bergonié581 enrolled

Overview

Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.

This a multicenter prospective cohort study. This study will be proposed to newly diagnosed advanced NSCLC patients. For included patients, archived paraffin embedded tumor tissue will be used for sequencing ; and blood sample will be collected for research purpose (plasma DNA collection and sequencing). Both tissue and liquid biopsy samples will follow usual processes and will be sent to the Molecular Pathology laboratory of the Investigation center.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

581

Conditions

Non Small Cell Lung Cancer Advanced Solid Tumor

Interventions

EGFR gene mutation analysis on liquid biopsyDIAGNOSTIC_TEST

Blood samples will be collected at inclusion for plasma DNA collection and analysis.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patients aged ≥ 18 years at time of proposal study, 2. Histologically confirmed non-small cell lung carcinoma, 3. No previous treatment for NSCLC, 4. Indication to EGFR status determination following HAS recommendation, 5. Voluntary signed and dated written informed consent prior to any study specific procedure 6. Patients with a social security in compliance with the French Law. Exclusion Criteria: 1. Treatment for advanced NSCLC started before liquid biopsy sampling. 2. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).

Locations (9)

Institut de Cancérologie de l'Ouest - Site Paul Papin

Angers, France

Institut Bergonie

Bordeaux, France

CHRU Lille

Lille, France

Hospices Civils de Lyon

Lyon, France

Outcomes

Primary Outcomes

To assess the detection rate of patients with an EGFR actionable alteration when using the combination of two diagnostic procedures which include liquid biopsy analysis (by droplet digital PCR or allele specific PCR) and tissue analysis

Resuls of each EGFR diagnostic procedure will be categorized as EGFR positive in case of the presence of an EGFR actionnable alteration ; as EGFR negative in case of the absence of an EGFR actionnable alteration ; or nor interpretable. A patient will be considered to have an EGFR actionable alteration if the mutation has been detected on the sequencing of tumor tissue OR if it has been detected on the liquid biopsy procedure

Time frame: within 3 weeks after signature of informed consent

Secondary Outcomes

The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only

A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by the liquid biopsy analysis if an EGFR actionable alteration is identified based on the liquid biopsy analysis

Time frame: within 3 weeks after signature of informed consent

The detection rate of patients with an EGFR actionable alteration based on tissue analysis only

A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by tissue analysis if an EGFR actionable alteration is identified based on the sequencing of tumor tissue

Time frame: within 3 weeks after signature of informed consent

The concordance and discordance rates between the two procedures

Concordance is defined whenever results of both techniques are identical (i.e. EGFR+ for both techniques or EGFR- for both techniques). Discordance is defined whenever results of both techniques are different.

Time frame: within 3 weeks after signature of informed consent

The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)

Data from ClinicalTrials.gov

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