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Brief Title: LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title: LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Study ID: NCT04703153
Brief Summary: To explore the non-inferiority of a cfDNA amplicon-based liquid biopsy technology vs. standard of care tissue biopsy-based NGS in detecting guideline- recommended biomarkers in patients with metastatic non-squamous Non-small Cell Lung Cancer (NSCLC), amongst other endpoints. To explore the non-inferiority of cfDNA-based LiquidHALLMARK test vs. cfDNA-based liquid biopsy competitor, both qualitatively and quantitatively for actionable mutation (percentage of allele frequency) profile results in a population of subjects who have at least one actionable mutation detected by tissue biopsy.
Detailed Description: 1. To explore the non-inferiority of a cfDNA amplicon-based liquid biopsy technology vs. standard of care tissue biopsy-based NGS in detecting guideline- recommended biomarkers in patients with metastatic non-squamous Non-small Cell Lung Cancer (NSCLC), amongst other endpoints. 2. To explore the non-inferiority of cfDNA-based LiquidHALLMARK test vs. cfDNA-based liquid biopsy competitor, both qualitatively and quantitatively for actionable mutation (percentage of allele frequency) profile results in a population of subjects who have at least one actionable mutation detected by tissue biopsy. 3. Condition or disease: NSCLC 4. Intervention/treatment: Observational
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
California Research Institute, Los Angeles, California, United States
University of Miami, Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Kaiser Permanente Hawaii Region Center for Integrated Health Care Research, Honolulu, Hawaii, United States
University of Maryland - Marlene and Stewart Greenbaum Cancer Center, Baltimore, Maryland, United States
New Jersey Cancer Care, Belleville, New Jersey, United States