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

Non Small Cell Lung Cancer Clinical Trial

— CIRCULAR  

Official title:

Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04912687
• Other study ID #: IB 2021-02
• Secondary ID: 2021-A00685-36
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2023
• Source: Institut Bergonié
• Contact: Isabelle SOUBEYRAN, MD, PhD
• Phone: (0)5.56.33.33.33
• Email: i.soubeyran[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Diagnostic Test:
• EGFR gene mutation analysis on liquid biopsy
Blood samples will be collected at inclusion for plasma DNA collection and analysis.

Locations

Country	Name	City	State
France	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	CHU Nice-Hopital de Cimiel	Nice
France	Institut Curie	Paris
France	CHU Poitiers	Poitiers
France	CHU de Rennes - Hopital Pontchaillou	Rennes
France	CHU Strasbourg	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	within 3 weeks after signature of informed consent
Secondary	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	within 3 weeks after signature of informed consent
Secondary	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.	within 3 weeks after signature of informed consent
Secondary	The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)	•; 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)	within 3 weeks after signature of informed consent
Secondary	Delay to obtain sequencing results	The delay between the date of the signature of the informed consent and the date of availability of the results for each procedure	within 3 weeks after signature of informed consent
Secondary	Delay for treatment initiation	The delay between the date of sample collection and the date of treatment initiation	within 3 months after signature of informed consent