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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT03042221
Collaborator
(none)
20
Enrollment
1
Location
137.3
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Targeted Therapy in Patients With EGFR, ALK, ROS1 or BRAF Mutations.
    Actual Study Start Date :
    Apr 20, 2016
    Anticipated Primary Completion Date :
    Nov 1, 2026
    Anticipated Study Completion Date :
    Sep 30, 2027

    Outcome Measures

    Primary Outcome Measures

    1. gene expression changes [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

    2. protein expression change [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)

    Secondary Outcome Measures

    1. Depth of Response [Study startup through 36 months]

      Correlation between the depths of tumor response (by RECIST v1.1) (percentage decrease in tumor size) with the presence of an EMT signature.

    Other Outcome Measures

    1. Evaluation of Adverse Events [Study startup through 36 months]

      Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    2. Success rate of Repeat Biopsy [Study startup through 36 months]

      Success rate of early rebiopsy in obtaining tumor samples that have evaluable material for RNA Seq and other analyses

    3. Progression Free Survival [Study startup through 36 months]

      Length of PFS as per RECIST 1.1

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Carry a diagnosis of stage IV lung adenocarcinoma with an activating mutation determined to respond to an estimated glomerular filtration rate (EGFR) TKI, alkaline phosphatase (ALK) or ROS Proto-Oncogene 1 (ROS1) fusion or BRAF V600E.

    • Aged 18 - 85 years or older

    • ECOG 0-2

    • Have a histologically confirmed diagnosis of lung adenocarcinoma harboring an EGFR sensitizing mutation (including, but not limited to: G719X, del exon 19, or L858R).

    • No prior therapy for metastatic disease.

    • Planned treatment with a single agent EGFR TKI including but not limited to:

    1. erlotinib,

    2. gefitinib,

    3. rociletinib (CO-1686),

    4. afatinib, or

    5. osimertinib (AZD-9291).

    • Patients must have at least one site of measurable disease ≥ least 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.

    • Patients must be willing to undergo an initial pre-treatment biopsy of tumor tissue (or have previously collected frozen tissue) and a follow-up biopsy 2 weeks (+/- 1 week) after treatment start

    Exclusion Criteria:

    • Concurrent health problem which would preclude tissue biopsy (eg hemophilia or other bleeding predisposition).

    • Patients whose only source of biopsiable disease is:

    1. intracranial,

    2. pleural effusion or any lesion that is deemed unsafe to biopsy by the treating physician or,

    3. interventional radiology.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado, Cancer Center Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Erin Schenk, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT03042221
    Other Study ID Numbers:
    • 15-2316.cc
    First Posted:
    Feb 3, 2017
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Lung Neoplasms

    Study Results

    No Results Posted as of Nov 5, 2021