Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-Small Cell Carcinoma of Lung, TNM Stage 4
- Sponsor
- University of Colorado, Denver
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- protein expression change
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
protein expression change
Time Frame: baseline 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)
gene expression changes
Time Frame: baseline 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
Secondary Outcomes
- Depth of Response(Study startup through 36 months)