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

STATUS

Recruiting
End date

Sep 30, 2027
participants needed

20
sponsor

University of Colorado, Denver

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Updated on 23 February 2022

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tyrosine

measurable disease

kinase inhibitor

BRAF

metastasis

lung adenocarcinoma

erlotinib

ROS1

EGFR

afatinib

gefitinib

osimertinib

proto-oncogene tyrosine-protein kinase ros

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.

Details

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 Identifier	NCT03042221
Sponsor	University of Colorado, Denver
Last Modified on	23 February 2022

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Eligibility		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
	erlotinib
	gefitinib
	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
	intracranial
	pleural effusion or any lesion that is deemed unsafe to biopsy by the treating physician or
	interventional radiology

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