Actively Recruiting
Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer
Led by University of Colorado, Denver · Updated on 2026-02-20
100
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying lung cancer patients with specific genetic mutations to understand how tumor cells survive early responses to targeted treatments called Tyrosine Kinase Inhibitors (TKIs). This observational study focuses on non-small cell lung cancer (NSCLC) at advanced stages, aiming to identify early survival mechanisms in tumors to help develop better combination therapies and improve patient outcomes. Participants will be grouped based on their treatment type: those receiving targeted therapy for gene mutations like EGFR, ALK, ROS1, or BRAF, and those receiving immunotherapy or chemotherapy plus immunotherapy without these mutations. The study includes collecting tumor biopsies and blood samples at the start and after about two weeks of treatment to analyze changes in gene and protein expression. Some patients may decline biopsy and participate through blood draws only. During the study, participants will undergo tumor biopsies if possible, blood draws, and ongoing monitoring of tumor response up to three years. Researchers will assess gene and protein changes early in treatment and evaluate the depth of tumor response over time. All participants must be able to consent and meet health criteria. The study support includes careful safety monitoring, with no prior systemic therapy allowed for metastatic disease.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Diagnosis of locally advanced or stage IV non-small cell lung cancer responsive to targeted therapies or immunotherapy
- ECOG performance status of 0 to 2
- Histologically confirmed NSCLC with activating mutations responsive to targeted therapy for certain cohorts
- No prior systemic therapy or radiation therapy for metastatic lung cancer (surgery alone permitted)
- Planned treatment with targeted therapy or immunotherapy depending on cohort
- At least one measurable tumor site of 2 cm or larger (for biopsy cohort)
- Primary or metastatic disease site amenable to biopsy (for biopsy cohort)
- Ability and willingness to sign informed consent
You will not qualify if you...
- Health conditions that prevent safe tissue biopsy (e.g., bleeding disorders)
- Biopsy site poses unacceptable procedural risk (e.g., pericardium, kidney) as judged by doctor
- Biopsy samples likely insufficient for evaluation (e.g., cerebrospinal or ascitic fluid)
- Planned follow-up care outside the University of Colorado Health System (blood draw cohorts)
- Unwillingness to allow use of residual clinical biopsy specimens in the study (blood draw cohorts)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessment
Participants undergo baseline biopsies and blood draws to identify biomarkers of tumor cell survival before starting systemic therapy.
1 to 2 visits depending on cohort assignment
Duration - Approximately 2 weeks (+/- 1 week)
Participants are monitored with biopsies and blood draws approximately 2 weeks after starting systemic therapy to evaluate gene and protein expression changes.
1 to 2 visits depending on cohort assignment
Duration - Up to 36 months
Participants are followed for up to 36 months to assess depth of response to therapy.
Visits scheduled per clinical care
Trial Site Locations
Total: 1 location
1
University of Colorado, Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
B
Brandi Kubala
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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