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.
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
Study Type
OBSERVATIONAL
Enrollment
151
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
Demonstrate the non-inferiority of cfDNA-based LiquidHALLMARK liquid biopsy assay vs. SOC tissue biopsy based NGS assay for mutation profile results
Explore the non-inferiority of cfDNA-based LiquidHALLMARK liquid biopsy assay vs. SOC tissue biopsy based NGS assay for mutation profile results in a population of subjects who have at least one of nine actionable genes (G9) - EGFR, ALK, RET, ROS1, NTRK fusions, MET, BRAF, ERBB2 and KRAS- detected by tissue biopsy.
Time frame: 34 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.