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

  • End date
    Sep 30, 2027
  • participants needed
  • sponsor
    University of Colorado, Denver
Updated on 23 February 2022
measurable disease
kinase inhibitor
lung adenocarcinoma
proto-oncogene tyrosine-protein kinase ros


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 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
Clinical Study IdentifierNCT03042221
SponsorUniversity of Colorado, Denver
Last Modified on23 February 2022


Yes No Not Sure

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
rociletinib (CO-1686)
afatinib, or
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
pleural effusion or any lesion that is deemed unsafe to biopsy by the treating physician or
interventional radiology
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