Plasma Predictive Features in Treating EGFR-Mutated Non-Small Cell Lung Cancer.
Christi M J Steendam, G D Marijn Veerman, Melinda A Pruis...
https://pubmed.ncbi.nlm.nih.gov/33138052Actively Recruiting
Age: 18Years +
All Genders
ID05221372
ProSpecTive sampling in dRiver mutation Pulmonary Oncology Patients on Tyrosine Kinase Inhibitors
Led by Erasmus Medical Center · Updated on 2022-02-18
1300
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying adults with non-small cell lung cancer who are being treated with tyrosine kinase inhibitors (TKI). The goal is to collect repeated blood samples to test for mutations and analyze how the drug is processed in the body. This observational study aims to better understand the presence of cancer mutations and drug levels during treatment and disease progression. Blood samples will be taken ideally before starting TKI therapy, then at weeks 4, 8, 12, and every 4 to 8 weeks following local care guidelines. If patients switch TKIs, blood collection continues under a new study number. Sampling is done during steady-state periods before the next dose, with the morning dose postponed until after blood withdrawal. When disease progresses, if a biopsy is performed as standard care, extra blood and biopsy samples will be collected for detailed molecular analysis. Participants will have blood drawn during routine care visits, with additional samples stored for advanced testing. Biopsy samples will be split for standard and fresh frozen storage to allow RNA and other molecular studies. Researchers will track mutation levels in plasma, drug concentrations, time to progression or death, overall survival, and correlations with biopsy results, body mass index, and smoking status. The study lasts up to 10 years, with assessments aligned to clinical care and no interference with treatment decisions.
CONDITIONS
Brief Title
ProSpecTive sAmpling in dRiver muTation Pulmonary Oncology Patients on Tyrosine Kinase Inhibitors (START-TKI)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 63; 18 years
- Able to understand the written informed and able to give informed consent
- Locally advanced or metastatic NSCLC with oncogenic driver mutation
- Treatment with TKI according to standard of care
You will not qualify if you...
- Unable to draw blood for study purposes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 10 years
Participants treated with tyrosine kinase inhibitors are observed with extra blood samples collected during routine blood withdrawals at multiple timepoints following standard-of-care guidelines.
Blood collection at baseline, week 4, 8, 12, then every 4 to 8 weeks during treatment
Diagnostic Evaluation
Duration - As needed during follow-up
When disease progression occurs, participants may undergo a rebiopsy as standard of care; on biopsy days, an extra blood sample and fresh frozen biopsy specimens are collected for further molecular analysis.
1 visit per rebiopsy event (in-person)
Long-term Monitoring
Duration - Up to 10 years
Participants continue to be monitored for mutation presence, plasma drug concentrations, and clinical outcomes until progression or death.
Continued blood sampling and clinical observation per standard care schedules
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
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Research Team
A
Anne-Marie Dingemans, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Sophie M Ernst, Ronald van Marion, Peggy N Atmodimedjo...
https://pubmed.ncbi.nlm.nih.gov/38615940Efficacy and Tolerability of Osimertinib and Sotorasib Combination Treatment for Osimertinib Resistance Caused by KRAS G12C Mutation: A Report of Two Cases.
Sophie M Ernst, Sevim Uzun, Marthe S Paats...
https://pubmed.ncbi.nlm.nih.gov/38096473