Actively Recruiting
Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy
Led by University of Colorado, Denver · Updated on 2026-02-20
100
Participants Needed
1
Research Sites
594 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A comparison of baseline tumor characteristics in oncogene-driven cancers to tumor characteristics after early response to Tyrosine Kinase Inhibitor (TKI) targeted treatment will allow identification of early adaptive mechanisms of cell survival. This will facilitate targeting and termination of these survival/ resistance pathways before they develop with rational combinations of therapeutic agents to improve outcomes.
CONDITIONS
Official Title
Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of locally advanced or stage IV non-small cell lung cancer (NSCLC) responsive to targeted therapies per NCCN guidelines
- Age 18 years or older
- ECOG performance status 0-2
- Histologically confirmed NSCLC with activating mutation responsive to targeted therapy per NCCN guidelines
- No prior systemic therapy for locally advanced or metastatic disease
- Planned treatment with targeted therapy specific to oncogene driver mutation
- At least one measurable disease site 2 cm or larger
- Disease site amenable to biopsy (for biopsy cohort)
- Ability to understand and willingness to sign informed consent
- For blood draw only cohort: patients who decline biopsy or do not have biopsy-amenable tumor site
- For immunotherapy cohort: histologically confirmed NSCLC without treatable activating mutation, planned first line immunotherapy or chemo-immunotherapy
- No prior systemic therapy or radiation therapy for lung cancer (surgery alone permitted)
You will not qualify if you...
- Concurrent health problems that prevent tissue biopsy (e.g., bleeding disorders)
- Biopsy source involving high procedural risk areas (e.g., pericardium, kidney)
- Biopsy source likely insufficient for genomic evaluation (e.g., cerebrospinal or ascitic fluid)
- Planned follow-up care outside the University of Colorado Health System (for blood draw cohorts)
- Unwillingness to allow use of residual clinical biopsy specimens in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado, Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
B
Brandi Kubala
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here