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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    200
  • sponsor
    Lucence Health Inc.
Updated on 30 June 2022
systemic therapy
BRAF
KRAS
ROS1
RET
HER2
EGFR
cancer chemotherapy
targeted therapy
NTRK
erbb2
liquid biopsy
adjuvant chemotherapy
lung carcinoma
squamous non-small cell lung cancer
proto-oncogene tyrosine-protein kinase ros
non-squamous non-small cell lung cancer

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.

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. Condition or disease: NSCLC
  3. Intervention/treatment: Observational

Details
Condition Non Small Cell Lung Cancer
Clinical Study IdentifierNCT04703153
SponsorLucence Health Inc.
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Eligible subjects whose physician intends to order tissue for genotyping at
by sending out tissue for analysis. Tissue CGP must be performed by Next
study enrollment, but there is insufficient material for analysis are still
Generation Sequencing (NGS). Other genomic platforms and methodologies for
eligible for enrollment
tissue genomic profiling, such as PCR, FISH or IHC are not eligible for this
study
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 Criteria

Patients who are unwilling to follow-up for evaluation of response to therapy
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