Clinical trial NCT04703153: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Keywords: biomarkers
cell-free DNA
cfDNA
CGP
liquid biopsy
lung cancer
NGS
tissue biopsy
Lead sponsor: Lucence Health Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 151
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment-naïve newly diagnosed, histologically confirmed, metastatic NSCLC patients

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

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

Primary outcomes:
measure: Demonstrate the non-inferiority of cfDNA-based LiquidHALLMARK liquid biopsy assay vs. SOC tissue biopsy based NGS assay for mutation profile results
timeFrame: 34 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: California Research Institute
state: California
city: Miami
country: United States
facility: University of Miami, Sylvester Comprehensive Cancer Center
state: Florida
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii Region Center for Integrated Health Care Research
state: Hawaii
city: Baltimore
country: United States
facility: University of Maryland - Marlene and Stewart Greenbaum Cancer Center
state: Maryland
city: Belleville
country: United States
facility: New Jersey Cancer Care
state: New Jersey
Study officials:
References: