Status:
UNKNOWN
LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Lucence Health Inc.
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
21+ years
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 metastati...
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 metast...
Eligibility Criteria
Inclusion
- 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, NTRK fusions, MET, BRAF, HER2 and KRAS.
- Tissue genotyping is to be performed by Comprehensive Genomic Profiling (CGP) either in-house (at study 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 and methodologies 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 is insufficient material for analysis are still eligible for enrollment.
- Patients with no previous surgical treatment, such as cancer resection, except patients with previously resected early stage NSCLC (stage I-IIIA), now with recurrent and metastatic disease, if tissue from a site of metastatic disease has been obtained within a 90 (ninety) calendar-day window of enrollment.
- Treatment naïve patients for metastatic disease, i.e., no previous systemic therapy such as chemotherapy, targeted therapy or immunotherapy for metastatic disease. Adjuvant therapy is allowable for eligible patients who have received prior adjuvant molecularly targeted therapy and they have completed this therapy at least 6 weeks prior to study enrollment.
- Patients with previously treated localized NSCLC (stage I-IIIA) are eligible if primary surgical resection and/or radiation treatment was completed at least 6 months prior to the development of metastatic disease and adjuvant chemotherapy, or targeted therapy completed at least 6 weeks prior to study enrollment.
- No past history of any histologically confirmed malignant invasive neoplasm (excluding the current diagnosis of lung cancer and any non-melanoma skin cancer that was treated surgically with curative intent) in the last 3 years.
- Ability to understand a written informed consent and willingness to sign it.
- ≥ 21 years of age.
Exclusion
- Patients who are unwilling to follow-up for evaluation of response to therapy
Key Trial Info
Start Date :
April 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04703153
Start Date
April 5 2021
End Date
December 31 2024
Last Update
March 9 2023
Active Locations (5)
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1
California Research Institute
Los Angeles, California, United States, 90027
2
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
3
Kaiser Permanente Hawaii Region Center for Integrated Health Care Research
Honolulu, Hawaii, United States, 96817
4
University of Maryland - Marlene and Stewart Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201