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

NCT03042221 | Recruiting DMC

• 1 other identifier: 15-2316.cc
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• gene expression changes

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

  baseline and 2 weeks (+/- 1 week) for each patient.

• protein expression change

  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)

  baseline and 2 weeks (+/- 1 week) for each patient.

Secondary Outcomes (1)

• Depth of Response

  Study startup through 36 months

Other Outcomes (3)

• Evaluation of Adverse Events

  Study startup through 36 months

• Success rate of Repeat Biopsy

  Study startup through 36 months

• Progression Free Survival

  Study startup through 36 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have a diagnosis of State IV Lung Adenocarcinoma with EGFR activating mutation

You may qualify if:

• Targetable Oncogene - Biopsy Cohort (includes blood draw)
• Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapies (per current NCCN guidelines)
• Aged 18 years or older
• ECOG 0-2
• Have a histologically confirmed diagnosis of NSCLC harboring an 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 the oncogene driver mutation.
• Patients must have at least one site of measurable disease ≥ 2cm.
• Primary disease site or site of metastatic disease must be amenable to biopsy.
• Patients must have the ability to understand and willingness to sign an informed consent document.
• Targetable Oncogene - Blood Draw Only Cohort
• Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapy (per NCCN guidelines)
• Aged 18 years or older
• ECOG 0-2
• Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)

You may not qualify if:

• Targetable Oncogene - Biopsy Cohort (includes blood draw)
• Concurrent health problem which would preclude tissue biopsy (e.g. hemophilia or other bleeding predisposition).
• Patients whose only biopsy source would involve sampling an anatomic area that carries an unacceptably high procedural risk (e.g. pericardium or kidney) as deemed by the treating physician or by a proceduralist performing the biopsy.
• Patients whose only biopsy source involves a sample that may not be evaluable due to insufficient genomic material (such as cerebrospinal or ascitic fluid) as deemed by the treating physician. .
• Targetable Oncogene Cohort and Immunotherapy Cohort - Blood Draw Only
• Planned follow up on therapy outside of the University of Colorado Health System
• Unwillingness to allow for residual clinical biopsy specimens to be utilized in this study.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado, Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Erin Schenk

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandi Kubala

CONTACT

303-724-1657; brandi.kubala@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 3, 2017
• Study Start: May 10, 2016
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)