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

Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - 85
Start Date:April 20, 2016
End Date:April 30, 2019
Contact:Mary K Jackson

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Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Targeted Therapy in Patients With EGFR, ALK, ROS1 or BRAF Mutations.

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.

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.
We found this trial at
Aurora, Colorado 80045
Principal Investigator: Robert Doebele, MD, PhD
Phone: 303-724-1650
Aurora, CO
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