Characterizing genetic profiles in advanced non-small cell lung cancer using liquid biopsies
Liquid Biopsies in Patients With Advanced Non-small Cell Lung Cancer
This study is testing whether a simple blood test can help find genetic changes in patients with advanced lung cancer to guide their treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Leon Berard Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 8 sites (Annecy and 7 other locations) |
| Trial ID | NCT02511288 on ClinicalTrials.gov |
What this trial studies
This project aims to analyze the genetic profiles of patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) through the use of liquid biopsies. By identifying molecular abnormalities in the plasma, the study seeks to provide a non-invasive method for detecting genetic alterations that can inform treatment decisions. The research focuses on patients who may not be eligible for traditional tissue biopsies and aims to enhance understanding of disease progression and treatment resistance. The findings could lead to better-targeted therapies for patients with specific genetic mutations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced non-small cell lung carcinoma (stage IIIB/IV), regardless of mutation status.
Not a fit: Patients who have already received treatment prior to their liquid biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment options and outcomes for patients with advanced non-small cell lung cancer.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for genetic profiling in cancer, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
COHORT 1 Inclusion Criteria: * Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) regardless of the mutation status * Inclusion at the time of diagnostic * Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report * Age ≥ 18 years * Covered by a health insurance * Signed consent Exclusion Criteria: \- Patients treated before their liquid biopsy COHORT 2 Inclusion criteria * Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) with one of the following molecular anomalies: Epidermal Growth Factor Receptor (EGFR), B-Raf proto oncogene (BRAF) or Human Epidermal Growth Factor Receptor-2 (HER2) mutations, Anaplatsic Lymphoma Kinase (ALK) or ROS porto-oncogene 1 (ROS1) translocation, Mesenchymal-epithelial transition factor (MET) amplification, RET rearrangement. * Inclusion at the time of diagnosis * Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report * Age ≥ 18 years * Covered by a health insurance * Signed consent COHORT 3 Inclusion criteria * Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) whatever the mutational or PD-L1 status. * Inclusion at the time of immunotherapy treatment initiation (1st or 2nd line) * Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report * Age ≥ 18 years * Covered by a health insurance * Signed consent Exclusion criteria \- Initiation of immunotherpy before their liquid biopsy
Where this trial is running
Annecy and 7 other locations
- Centre Hospitalier Annecy Genevois — Annecy, France (Active_not_recruiting)
- CH Fleyriat — Bourg-en-Bresse, France (Active_not_recruiting)
- Hôpital Louis Pradel — Bron, France (Active_not_recruiting)
- CHU Grenoble Alpes — Grenoble, France (Active_not_recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- CHRU de Saint-Etienne — Saint-Priest-en-Jarez, France (Active_not_recruiting)
- Institut de Cancérologie Lucien Neuwirth — Saint-Priest-en-Jarez, France (Active_not_recruiting)
- Hôpital Nord Ouest — Villefranche-sur-Saône, France (Active_not_recruiting)
Study contacts
- Study coordinator: Pierre Saintigny, MD, PhD
- Email: pierre.saintigny@lyon.unicancer.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.