Official Title
LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Brief Title
LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Protocol ID
NCT04703153
Lead Sponsor
Lucence Health Inc.
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
Study Period
-
Enrollment Count
151 participants
Eligibility Criteria
Inclusion Criteria:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Ability to understand a written informed consent and willingness to sign it.
8. ≥ 21 years of age.
Exclusion Criteria:
1. Patients who are unwilling to follow-up for evaluation of response to therapy
Filters
Non Small Cell Lung Cancer
UNKNOWN
ADULT
OLDER_ADULT