LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (LIQUIK)

• ClinicalTrials.gov Identifier: NCT04703153
• Recruitment Status: Active, not recruiting
• First Posted: January 11, 2021
• Last Update Posted: March 9, 2023
• Sponsor: Lucence Health Inc.
• Information provided by (Responsible Party): Lucence Health Inc.

Study Description

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.

Condition or disease
Non Small Cell Lung Cancer

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 Design

• Study Type: Observational
• Actual Enrollment: 151 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
• Actual Study Start Date: April 5, 2021
• Actual Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2024

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Demonstrate the non-inferiority of cfDNA-based LiquidHALLMARK liquid biopsy assay vs. SOC tissue biopsy based NGS assay for mutation profile results [ Time Frame: 34 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Treatment-naïve newly diagnosed, histologically confirmed, metastatic NSCLC patients

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

Contacts and Locations

Locations

United States, California

California Research Institute

Los Angeles, California, United States, 90027

United States, Florida

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

United States, Hawaii

Kaiser Permanente Hawaii Region Center for Integrated Health Care Research

Honolulu, Hawaii, United States, 96817

United States, Maryland

University of Maryland - Marlene and Stewart Greenbaum Cancer Center

Baltimore, Maryland, United States, 21201

United States, New Jersey

New Jersey Cancer Care

Belleville, New Jersey, United States, 07109

Sponsors and Collaborators

Lucence Health Inc.

More Information

• Responsible Party: Lucence Health Inc.
• ClinicalTrials.gov Identifier: NCT04703153
• Other Study ID Numbers: LIQUIK-01
• First Posted: January 11, 2021
• Last Update Posted: March 9, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lucence Health Inc.:

biomarkers; cell-free DNA; cfDNA; CGP; liquid biopsy; lung cancer; NGS; tissue biopsy

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms