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

Not Applicable

Recruiting

• Conditions: Advanced Solid Tumor; Non Small Cell Lung Cancer
• Interventions: Diagnostic Test: EGFR gene mutation analysis on liquid biopsy

• Registration Number: NCT04912687
• Lead Sponsor: Institut Bergonié

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-03
• Study Start: 2022-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 580

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	EGFR gene mutation analysis on liquid biopsy	For all patients, blood sample will be collected at inclusion (liquid biopsy) for sequencing. As per standard management, for all of these patients, EGFR gene mutation will be also analyzed on archived tumor sample.

Primary Outcome Measures

Name	Time	Method
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	within 3 weeks after signature of informed consent	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

Secondary Outcome Measures

Name	Time	Method
The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only	within 3 weeks after signature of informed consent	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
The concordance and discordance rates between the two procedures	within 3 weeks after signature of informed consent	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.
The detection rate of patients with an EGFR actionable alteration based on tissue analysis only	within 3 weeks after signature of informed consent	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
The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)	within 3 weeks after signature of informed consent	•; Failure of a procedure (sequencing of tumor tissue or liquid biopsy) is defined whenever the procedure fails to provide an interpretable result (Reasons for failure will be collected, i.e. insufficient DNA quantity, poor DNA quality, insufficient DNA/tissue quantity, poor DNA/tissue quality, analytical failure)
Delay to obtain sequencing results	within 3 weeks after signature of informed consent	The delay between the date of the signature of the informed consent and the date of availability of the results for each procedure
Delay for treatment initiation	within 3 months after signature of informed consent	The delay between the date of sample collection and the date of treatment initiation

Trial Locations

Locations (9)

Institut Curie; 🇫🇷 Paris, France

CHRU Lille; 🇫🇷 Lille, France

Institut Bergonie; 🇫🇷 Bordeaux, France

CHU de Rennes - Hopital Pontchaillou; 🇫🇷 Rennes, France

CHU Poitiers; 🇫🇷 Poitiers, France

Institut de Cancérologie de l'Ouest - Site Paul Papin; 🇫🇷 Angers, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHU Nice-Hopital de Cimiel; 🇫🇷 Nice, France

CHU Strasbourg; 🇫🇷 Strasbourg, France