Lung Cancer Clinical Trial
Official title:
Spanish Lung Liquid vs. Invasive Biopsy Program
Tumor Derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The primary objective of this study is to demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping.
Primary objective:
To demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping as it
pertains to the detection of clinically-actionable biomarkers in first line, treatment naïve,
metastatic non-squamous NSCLC.
The following secondary objectives will be studied:
- Turn around Time (TAT) of cfDNA vs. tissue results.
- Time to treatment (TtT) initiation.
- Quantity not sufficient rate (QNS) of tissue for clinically-actionable biomarker
testing.
- Tumor Not Detected (TND) rate of cfDNA in blood.
- Rescue rate of QNS samples using cfDNA-derived genotyping.
- Rate response for patients that are actionable biomarker positive (either in cDNA or
tissue) treated with target-drugs according investigator criteria. Up to three RECIST
assessments per patient will be retrospectively done by external personnel (no
investigational team).
- Rate of discovery of genomically mediated, acquired resistance to targeted therapies in
the biomarker-positive subsets.
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