Understanding resistance to osimertinib in lung cancer patients
Relationship Between Resistance to the Tyrosine Kinase Inhibitor Osimertinib and Pharmacokinetics in Non-small Cell Lung Cancer: Toward an Individualization of the Treatment (RESISTYR)
This study looks at patients with non-small cell lung cancer to see if they have any markers that show why they might not respond to the drug osimertinib, using blood samples instead of tissue biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Drugs / interventions | Osimertinib, erlotinib, gefitinib, dasatinib |
| Locations | 4 sites (Lorient and 3 other locations) |
| Trial ID | NCT05020275 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with non-small cell lung cancer (NSCLC) who have an activating mutation of the epidermal growth factor receptor (EGF-R) and are not currently receiving osimertinib. The study aims to investigate the pharmacokinetics of osimertinib and identify biomarkers that predict resistance to this treatment. By analyzing blood samples for circulating tumor DNA (ctDNA), researchers hope to monitor disease progression and understand the factors contributing to treatment resistance. This approach allows for a less invasive method of tracking the disease compared to traditional tissue biopsies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with locally advanced or metastatic NSCLC harboring specific EGF-R mutations.
Not a fit: Patients currently receiving osimertinib or those who have previously been treated with EGF-R tyrosine kinase inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for lung cancer patients by identifying factors that contribute to resistance against osimertinib.
How similar studies have performed: While studies on osimertinib have shown varying responses, this specific approach focusing on ctDNA as a biomarker for resistance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age\> 18 years old * Man or woman * Diagnosis of locally advanced non-small cell bronchial adenocarcinoma (not eligible for locoregional treatment) or metastatic * Tumor with an activating mutation of EGF-R (deletion of exon 19 or L858R, L861x, or G719x mutation) * No one opposed to his participation in the research * Dated and signed consent form * Patient in good general condition according to WHO (PS: 0 or 1) Exclusion Criteria: * Previous treatment of NSCLC with an EGF-R tyrosine kinase inhibitor * Adult persons subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty. * Treatment with Osimertinib on going * Co-treatments with a potent enzyme inducing or inhibitor compound within 2 weeks before starting treatment with Osimertinib * Participation in intervention research on a drug
Where this trial is running
Lorient and 3 other locations
- CH Bretagne Sud (Site du Scorff) — Lorient, France (Recruiting)
- Chu de Rennes (Service Pneumologie) — Rennes, France (Recruiting)
- CH Saint Malo (Service de Pneumologie) — Saint Malo, France (Not_yet_recruiting)
- CH Bretagne Atlantique — Vannes, France (Recruiting)
Study contacts
- Principal investigator: Camille TRON, MD — Rennes University Hospital
- Study coordinator: Camille TRON
- Email: camille.tron@chu-rennes.fr
- Phone: 2 99 28 68 28
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.