Clinical trial · Interventional
Osimertinib Resistance in Patients With Non-small-cell Lung Carcinoma That Have Progressed.
Osimertinib Resistance Analysis in Patients With EGFR Mutation Positive Non-small-cell Lung Carcinoma That Have Progressed on Osimertinib Treatment'
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Initially, patients with EGFR mutation positive NSCLC respond well to osimertinib, a third generation EGFR tyrosine kinase inhibitor (TKI), but eventually progress. Upon progression multiple resistance mechanisms have been described and new therapeutic strategies are being developed to target these resistance mechanisms. Thorough and complete osimertinib resistance analysis enables optimal treatment decision making and might identify new targets for molecular treatment, thereby potentially improving patient outcome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small-cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Diagnostic Test | — | UNRESOLVED |
| ctDAN analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Biopsy and blood
- description
- A histological core biopsy of a tumor lesion and a blood sample for ctDNA analysis will be collected
- interventionNames
- Diagnostic Test: biopsy
- Diagnostic Test: ctDAN analysis
Primary outcomes (2)
- measure
- EGFR TKI resistance analysis on tumor biopsies and ctDNA
- timeFrame
- Trough study completion, an average of 2 years
- description
- Complete osimertinib resistance analysis in tissue and plasma for all patients in the Netherlands that progress on osimertinib treatment
- measure
- Recommendation for subsequent treatment
- timeFrame
- Trough study completion, an average of 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDvan der Wel JWT, Ernst SM, Jebbink M, van den Broek D, Badrising SK, Steinbusch LC, Ruiter G, Theelen WSME, van Veggel BAMH, Smit J, Dingemans AM, Paats MS, Dubbink HJ, Hashemi SMS, Radonic T, Cohen D, van der Wekken AJ, Ter Elst A, Timens W, Hendriks LE, Speel EJM, Disselhorst MMJ, Welling A, van der Meer F, Bosch LJW, Monkhorst K, Boelens MC, Smit EF, de Langen AJ. Determining the optimal approach to identify osimertinib resistance; the first line osimertinib cohort of the OSIRIS study. Lung Cancer. 2025 Nov;209:108783. doi: 10.1016/j.lungcan.2025.108783. Epub 2025 Sep 28. PMID 41039677