Non Small Cell Lung CancerLIQUIKNCT04703153
LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
An observational study of Non Small Cell Lung Cancer, run by Lucence Health Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 151 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Apr 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Treatment-naïve newly diagnosed, histologically confirmed, metastatic NSCLC patients
Who may be able to join
- 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.
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- 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.
Who cannot join
- Patients who are unwilling to follow-up for evaluation of response to therapy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Maryland - Marlene and Stewart Greenbaum Cancer Center
Baltimore, Maryland, 21201
New Jersey Cancer Care
Belleville, New Jersey, 07109
Kaiser Permanente Hawaii Region Center for Integrated Health Care Research
Honolulu, Hawaii, 96817
California Research Institute
Los Angeles, California, 90027
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
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.
Read the detailed description
- 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: NSCLC
- Intervention/treatment: Observational
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- biomarkers, cell-free DNA, cfDNA, CGP, liquid biopsy, lung cancer, NGS, tissue biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the non-inferiority of cfDNA-based LiquidHALLMARK liquid biopsy assay vs. SOC tissue biopsy based NGS assay for mutation profile results
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.
Measured: 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start5 Apr 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucence Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703153
- Sponsor's protocol ID
- LIQUIK-01
- Acronym
- LIQUIK
- Status last verified
- Mar 2023
- First submitted
- 7 Jan 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Samol J, Ng D, Poh J, Tan MH, Dawar R, Carney J, Orsini J Jr, Scilla K, Tan YO, Chin TM, Toh CK, Goh BC, Lopes G. Prospective Multicenter Study Evaluating a Combined Circulating Tumor DNA and Circulating Tumor RNA Liquid Biopsy in Metastatic Non-Small Cell Lung Cancer (LIQUIK). JCO Precis Oncol. 2025 Jun;9:e2500181. doi: 10.1200/PO-25-00181. Epub 2025 Jun 26.
PubMed 40570258
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT04703153
- Acronym / sponsor ID
- LIQUIK / LIQUIK-01
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- biomarkers, cell-free DNA, cfDNA, CGP, liquid biopsy, lung cancer, NGS, tissue biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Lucence Health Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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: NSCLC
- Intervention/treatment: Observational
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment-naïve newly diagnosed, histologically confirmed, metastatic NSCLC patients
Key inclusion criteria (11 listed)
- Patients with newly diagnosed, histologically confirmed, metastatic non-squamous NSCLC whom:
- 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.
Key exclusion criteria (1 listed)
- Patients who are unwilling to follow-up for evaluation of response to therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Derived from this study: PubMed 40570258Samol J, Ng D, Poh J, Tan MH, Dawar R, Carney J, Orsini J Jr, Scilla K, Tan YO, Chin TM, Toh CK, Goh BC, Lopes G. Prospective Multicenter Study Evaluating a Combined Circulating Tumor DNA and Circulating Tumor RNA Liquid Biopsy in Metastatic Non-Small Cell Lung Cancer (LIQUIK). JCO Precis Oncol. 2025 Jun;9:e2500181. doi: 10.1200/PO-25-00181. Epub 2025 Jun 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Lucence Health Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04703153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.