Observational Study of Early Rebiopsy in NSCLC with Targeted Therapies

This observational study aims to understand how lung cancer cells change early in response to targeted treatments like Tyrosine Kinase Inhibitors (TKIs). Researchers will compare tumor characteristics at the beginning of treatment to those after about two weeks. This helps identify how cancer cells survive and adapt, which could lead to better ways to combine treatments and improve outcomes. You may be eligible if you have locally advanced or stage IV non-small cell lung cancer (NSCLC) with specific gene mutations (EGFR, ALK, ROS1, or BRAF) that respond to targeted therapies, are aged 18 to 85, and have an ECOG score of 0-2 (meaning you are fully active or can care for yourself with some limitations). The study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will have tumor characteristics measured at the start of the study and again approximately two weeks later. This involves a biopsy and blood draw.
Compensation
Not stated in the trial record.
Follow-up
Gene and protein expression changes are measured at baseline and at 2 weeks (+/- 1 week) for each patient.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03042221

Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy

Recruiting
Not specifiedAges 18–85Observational
University of Colorado, Denver
~100 participants
Updated 2026-02-20 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
gene expression changes
Measured over baseline and 2 weeks (+/- 1 week) for each patient.
+1 more outcome measured
Non-Small Cell Carcinoma of Lung, TNM Stage 4
Non-Small Cell Lung Cancer
EGFR Gene Mutation
ALK Gene Mutation
ROSE Cluster 1
BRAF V600E
1 sites across 1 states
Colorado1
  • Erin Schenk · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

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  • gene expression changesbaseline and 2 weeks (+/- 1 week) for each patient.

    change from baseline of tumor gene expression profile at 2 weeks. Global gene expression data will be collected using RNAseq

  • protein expression changebaseline and 2 weeks (+/- 1 week) for each patient.

    change from baseline of protein gene expression profile at 2 weeks as measured by multiplex protein assay (proteins to be assayed include: e-cadherin, vimentin, fibronectin, CD4, CD8, CD14, CD16, CD206, PDL1, and CSF1R)