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LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic Biomarkers in Patients with Advanced Non-small Cell Lung Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic Biomarkers in Patients with Advanced Non-small Cell Lung Cancer
 
Region Sponsors
Hawaii
Lucence Health, Inc.
 
Acronym KP IRB No.
LIQUIK 1709816-1
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
 
Purpose
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 CellLung Cancer (NSCLC), amongst other endpoints.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Patients with newly diagnosed, histologically confirmed, metastatic non-squamous NSCLC whom: Have already received standard-of-care tissue genotyping using Next Generation Sequencing (NGS)for lung cancer at clinician's discretion, including at least EGFR, ALK, RET, ROS1, NTRK fusions,MET, BRAF, HER2 and KRAS, in the last 90 (ninety) calendar days of enrollment or Are scheduled to receive standard-of-care tissue genotyping using Next Generation Sequencing(NGS) for lung cancer at clinician's discretion, including at least EGFR, ALK, RET, ROS1, NTRKfusions, MET, BRAF, HER2 and KRAS
  • Tissue genotyping is to be performed by Comprehensive Genomic Profiling (CGP) either in-house (atstudy site laboratory) or at an outside CAP-accredited laboratory by sending out tissue for analysis.Tissue CGP must be performed by Next Generation Sequencing (NGS). Other genomic platforms andmethodologies for tissue genomic profiling, such as PCR, FISH or IHC are not eligible for this study. Eligible subjects whose physician intends to order tissue for genotyping at study enrollment, but there isinsufficient material for analysis are still eligible for enrollment
  • Patients with no previous surgical treatment, such as cancer resection, except patients with previouslyresected early stage NSCLC (stage I-IIIA), now with recurrent and metastatic disease, if tissue from asite of metastatic disease has been obtained within a 90 (ninety) calendar-day window of enrollment
 
Exclusion Criteria
  • Patients who are unwilling to follow-up for evaluation of response to therapy

 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
 
KP Clinical Facility
  • Moanalua Medical Center and Clinic
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Carney, MD
Contact Information:
- Shelley Clark, RN
-Moanalua Medical Center and Clinic


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