Analyzing resistance to osimertinib in lung cancer patients
Osimertinib Resistance Analysis in Patients With EGFR Mutation Positive Non-small-cell Lung Carcinoma That Have Progressed on Osimertinib Treatment'
This study is testing how and why some lung cancer patients stop responding to the drug osimertinib after their initial treatment, to help find better ways to treat them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | osimertinib |
| Locations | 6 sites (Amsterdam, Noord-Holland and 5 other locations) |
| Trial ID | NCT04737382 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with non-small-cell lung carcinoma (NSCLC) who have progressed after initial treatment with osimertinib, a targeted therapy for EGFR mutation-positive tumors. It aims to identify the various resistance mechanisms that develop, such as mutations in the EGFR gene or alterations in downstream signaling pathways. By utilizing next-generation sequencing and circulating tumor DNA analysis, the study seeks to optimize treatment decisions and potentially uncover new therapeutic targets. The ultimate goal is to improve patient outcomes through a better understanding of resistance to osimertinib.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically confirmed metastatic NSCLC who have a sensitizing EGFR mutation and have experienced disease progression during osimertinib treatment.
Not a fit: Patients who have discontinued osimertinib prior to the study or have started a new line of anticancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with osimertinib-resistant NSCLC.
How similar studies have performed: Other studies have shown success in targeting resistance mechanisms in lung cancer, making this approach promising yet still evolving.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed metastatic NSCLC, characterized by a sensitizing EGFR mutation. 2. Progressive disease, as assessed by the treating physician during osimertinib monotherapy. 3. Eligible for subsequent treatment. 4. Willing to undergo a histological biopsy and withdrawal of a blood sample for ctDNA analysis. 5. Technically possible to take a histological biopsy. Exclusion Criteria: - 1. Osimertinib discontinuation before blood draw and / or histological tumor biopsy. 2. Initiation of a new line of anticancer therapy before blood draw and / or histological tumor biopsy.
Where this trial is running
Amsterdam, Noord-Holland and 5 other locations
- The Netherlands Cancer Institute-Antoni van Leeuwenhoek — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Vrije Universiteit Medisch Centrum — Amsterdam, Netherlands (Not_yet_recruiting)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (Not_yet_recruiting)
- Academisch Ziekenhuis Maastricht — Maastricht, Netherlands (Not_yet_recruiting)
- Radboud Universitair Medisch Centrum — Nijmegen, Netherlands (Not_yet_recruiting)
- Erasmus MC, Universitair Medisch Centrum Rotterdam — Rotterdam, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: J de Langen, MD, PhD — The Netherlands Cancer Institute-Antoni van Leeuwenhoek
- Study coordinator: J de Langen, MD, PhD
- Email: j.d.langen@nki.nl
- Phone: 0031205129111
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.