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

NCT04912687 | Completed

• 2 other identifiers: IB 2021-022021-A00685-36
• Study Type: interventional
• Target: 581
• Locations: 1 country
• Sites: 9

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.

Conditions

Advanced Solid Tumor; Non Small Cell Lung Cancer

Keywords

non-small cell lung cancer; EGFR detection; liquid biopsy

Outcome Measures

Primary Outcomes (1)

• 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

  within 3 weeks after signature of informed consent

Secondary Outcomes (6)

• 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

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

  within 3 weeks after signature of informed consent

• The concordance and discordance rates between the two procedures

  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)

  within 3 weeks after signature of informed consent

• Delay to obtain sequencing results

  within 3 weeks after signature of informed consent

Study Arms (1)

All patients

EXPERIMENTAL

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.

Diagnostic Test: EGFR gene mutation analysis on liquid biopsy

Interventions

EGFR gene mutation analysis on liquid biopsy DIAGNOSTIC_TEST

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

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥ 18 years at time of proposal study,
• Histologically confirmed non-small cell lung carcinoma,
• No previous treatment for NSCLC,
• Indication to EGFR status determination following HAS recommendation,
• Voluntary signed and dated written informed consent prior to any study specific procedure
• Patients with a social security in compliance with the French Law.

You may not qualify if:

• Treatment for advanced NSCLC started before liquid biopsy sampling.
• Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).

Sponsors & Collaborators

• Institut Bergonié: lead
• AstraZeneca: collaborator

Study Sites (9)

Institut de Cancérologie de l'Ouest - Site Paul Papin

Angers, 49000, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CHRU Lille

Lille, 59037, France

Location

Hospices Civils de Lyon

Lyon, 69002, France

Location

CHU Nice-Hopital de Cimiel

Nice, 06000, France

Location

Institut Curie

Paris, 75248, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

CHU de Rennes - Hopital Pontchaillou

Rennes, 35033, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicentric prospective cohort in which newly diagnosed advanced NSCLC patients will be included. For all patients, both tumor and liquid biopsy samples will be used for sequencing and detection of EGFR gene mutation

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: January 1, 2022
• Primary Completion: January 17, 2026
• Study Completion: January 17, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)