Correlation Between Tissue and Plasmatic EGFR in CBNPC With EGFR Mutation or Predictive Factor of EGFR Mutation

NCT03265496 | Terminated

• 2 other identifiers: CONCORDE-15102015-A01744-45
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

Condorde main objective is to evaluate the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed on ctDNA after liquid biopsy. EGFR status will be assessed by real time PCR (rtPCR), digital PCR (dPCR) and Next Generation Sequencing (NGS) in patients with chemotherapy naive lung carcinoma.

Conditions

Nsclc

Outcome Measures

Primary Outcomes (1)

• Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. NGS.

  For patient with mutant EGFR. Evaluate, by next generation sequencing at diagnostic, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy.

  Baseline

Secondary Outcomes (8)

• Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. rtPCR.

  Baseline

• Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. dPCR.

  Baseline

• Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. NGS.

  From Baseline to disease progression, up to 2 years

• Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. rtPCR.

  From Baseline to disease progression, up to 2 years

• Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. dPCR.

  From Baseline to disease progression, up to 2 years

Other Outcomes (2)

• Mutation in ctDNA

  From Baseline to disease progression, up to 2 years

• expression pattern of tumor grade and resistance

  From Baseline to disease progression, up to 2 years

Study Arms (1)

study procedure

EXPERIMENTAL

Clinical exam. Liquid biopsy. Diagnostic exam (biopsy and imagery). 1st line treatment. tumor evaluation. Biopsy

Procedure: Clinical exam; Procedure: Liquid biopsy; Procedure: Diagnostic exam; Drug: 1st line treatment; Procedure: tumor evaluation; Biological: Biopsy

Interventions

Clinical exam PROCEDURE

Clinical exam is performed before treatment start

study procedure

Liquid biopsy PROCEDURE

Liquid biopsy will be performed at baseline and every 3 cycles of chemotherapy until progression disease

study procedure

Diagnostic exam PROCEDURE

Diagnostic exam (biopsy and imagery exam) will be performed at baseline if not previously done or incompletely done.

study procedure

1st line treatment DRUG

1st line chemotherapy (chemotherapy or EGFR targeted therapy) will be performed until progression disease.

Also known as: 1st line chemotherapy

study procedure

tumor evaluation PROCEDURE

Tumor evaluation will be performed every 3 cycles of chemotherapy

study procedure

Biopsy BIOLOGICAL

Biopsy will be performed at the end of study, after progression disease, if a mutation of EGFR is detected in tumor DNA.

study procedure

Eligibility Criteria

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

You may qualify if:

• At least 18 years
• Metastatic lung carcinoma
• With: - EGFR gene mutation
• Or at least 2 predictive factors of addictive mutation (Women, non smocking or cessation \> 3 years, Asiatic, lung adenocarcinoma)
• Eligible for 1st line treatment
• Performance status ≤ 3
• Available tumor sample or tumor reachable for biopsy
• With informed and signed consent
• Affiliation to the National Social Security System

You may not qualify if:

• Previous radiotherapy treatment in months preceding initials samples
• Pregnant or breastfeeding women
• Patient not able to give consent or unwilling to provide consent

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• University Hospital, Lille: collaborator

Study Sites (2)

Centre Oscar Lambret

Lille, 59020, France

Location

CHRU Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Liquid Biopsy; Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Kotecki Nuria, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

• Cortot Alexis, Pr

  CHRU LILLE

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 29, 2017
• Study Start: July 7, 2016
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)