Osimertinib Resistance in Patients With Non-small-cell Lung Carcinoma That Have Progressed.
OSIRIS
Osimertinib Resistance Analysis in Patients With EGFR Mutation Positive Non-small-cell Lung Carcinoma That Have Progressed on Osimertinib Treatment'
1 other identifier
interventional
200
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 22, 2019
CompletedFirst Submitted
Initial submission to the registry
October 24, 2019
CompletedFirst Posted
Study publicly available on registry
February 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2024
CompletedOctober 10, 2023
October 1, 2023
5 years
October 24, 2019
October 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
EGFR TKI resistance analysis on tumor biopsies and ctDNA
Complete osimertinib resistance analysis in tissue and plasma for all patients in the Netherlands that progress on osimertinib treatment
Trough study completion, an average of 2 years
Recommendation for subsequent treatment
Evaluation of these results in an MTB meeting and recommendations for subsequent treatment.
Trough study completion, an average of 2 years
Secondary Outcomes (3)
Evaluate recommended and actually treatment
Trough study completion, an average of 2 years
Evaluate plasma and tumor tissue
Trough study completion, an average of 2 years
Evaluate success rate
Trough study completion, an average of 2 years
Study Arms (1)
Biopsy and blood
OTHERA histological core biopsy of a tumor lesion and a blood sample for ctDNA analysis will be collected
Interventions
The formalin fixed material will be processed for molecular analysis in a clinically validated diagnostic pipeline according to ISO 15189 or other acceptable standard
ctDNA analysis will be performed using the AVENIO ctDNA targeted kit according to the guidelines from the manufacturer with respect to isolation, library preparation and bioinformatics analysis.
Eligibility Criteria
You may qualify if:
- Histologically confirmed metastatic NSCLC, characterized by a sensitizing EGFR mutation.
- \. Progressive disease, as assessed by the treating physician during osimertinib monotherapy.
- \. Eligible for subsequent treatment. 4. Willing to undergo a histological biopsy and withdrawal of a blood sample for ctDNA analysis.
- \. Technically possible to take a histological biopsy.
You may not qualify if:
- \- 1. Osimertinib discontinuation before blood draw and / or histological tumor biopsy.
- \. Initiation of a new line of anticancer therapy before blood draw and / or histological tumor biopsy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Netherlands Cancer Institutelead
- AstraZenecacollaborator
Study Sites (6)
The Netherlands Cancer Institute-Antoni van Leeuwenhoek
Amsterdam, North Holland, 1066 CX, Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Erasmus MC, Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands
Related Publications (1)
van 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: 41039677DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J de Langen, MD, PhD
The Netherlands Cancer Institute-Antoni van Leeuwenhoek
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2019
First Posted
February 3, 2021
Study Start
August 22, 2019
Primary Completion
August 22, 2024
Study Completion
August 22, 2024
Last Updated
October 10, 2023
Record last verified: 2023-10