Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TK⌠(NCT03042221) | Clinical Trial Compass
RecruitingNot Applicable
Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy
United States100 participantsStarted 2016-05-10
Plain-language 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.
Who can participate
Age range18 Years â 85 Years
SexALL
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Inclusion criteria
â. Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapies (per current NCCN guidelines)
â. Aged 18 years or older
â. ECOG 0-2
â. Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)
â. No prior systemic therapy for locally advanced or metastatic disease.
â. Planned treatment with targeted therapy specific to the oncogene driver mutation.
â. Patients must have at least one site of measurable disease ⼠2cm.
â. Primary disease site or site of metastatic disease must be amenable to biopsy.
Exclusion criteria
â. Concurrent health problem which would preclude tissue biopsy (e.g. hemophilia or other bleeding predisposition).
â. 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.
â. 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. .
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What they're measuring
1
gene expression changes
Timeframe: baseline and 2 weeks (+/- 1 week) for each patient.
2
protein expression change
Timeframe: baseline and 2 weeks (+/- 1 week) for each patient.