Understanding resistance to lung cancer treatment
Understanding and Overcoming the Early Adaptive Resistance to EGFR Tyrosine-kinase Inhibitors in Lung Cancer Patients
This study is trying to understand why some people with non-small cell lung cancer don't respond to a specific treatment and will involve 40 patients providing blood samples to help find better ways to overcome this resistance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Drugs / interventions | Osimertinib, chemotherapy |
| Locations | 1 site (Toulouse, Occitanie) |
| Trial ID | NCT04222335 on ClinicalTrials.gov |
What this trial studies
This study investigates the mechanisms behind early adaptive resistance to EGFR tyrosine-kinase inhibitors in patients with non-small cell lung cancer (NSCLC) who have EGFR mutations. By utilizing advanced technologies such as patient-derived xenografts and circulating tumor cells, the research aims to characterize drug-tolerant cells and identify potential biomarkers associated with resistance. The study will involve 40 patients who will provide blood samples to monitor these changes and explore new therapeutic strategies to combat resistance. Treatment with osimertinib will be administered according to existing guidelines, while the focus remains on understanding the underlying biology of resistance.
Who should consider this trial
Good fit: Ideal candidates are patients with non-operable or metastatic NSCLC who have an EGFR activating mutation and are eligible for treatment with osimertinib.
Not a fit: Patients with exon 20 EGFR mutations or those with existing resistance mutations will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to new treatments that effectively overcome resistance in lung cancer patients, improving their outcomes.
How similar studies have performed: While studies on EGFR-TKI resistance exist, this specific approach focusing on drug-tolerant cells is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with non operable and / or metastatic non-small cell lung cancer documented histologically. * Pathological diagnosis of NSCLC carrying an EGFR activating mutation associated with sensitivity to the tyrosine kinase inhibitors (TKI) (exons 18, 19 and 21). * Sufficient tissue sample quantity and quality for translational research * Naïve TKI-treated EGFR patient who can receive first-line treatment with Osimertinib or second-line after chemotherapy Exclusion Criteria: * Any patient with an exon 20 EGFR mutation. * Any disease or pathology that recommend not to perform blood samples collection * Any psychological, family, geographical or social condition that could potentially, according to the investigator's judgment, prevent the collection of informed consent or interfere with compliance with the study protocol * Patient with a resistance mutation of EGFR * Patient under State Medical Assistance * Patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curatorship or safeguard of justice
Where this trial is running
Toulouse, Occitanie
- Toulouse University Hospital — Toulouse, Occitanie, France (Recruiting)
Study contacts
- Principal investigator: Julien MAZIERES, MD; PHD — Toulouse University Hospitals
- Study coordinator: Julien MAZIERES, MD; PHD
- Email: mazieres.j@chu-toulouse.fr
- Phone: +33 5 67 77 18 37
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.