SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuardant Health, Inc.
About this trial
The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old
Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study
Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy
Able to understand, and capable of providing written consent to participate in the study
Disqualifiers
History of prior solid malignancy or hematological malignancy within five years of enrollment
Life expectancy ≤12 weeks
Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen
Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression
Trial population
The primary study population will include participants with Non-small cell lung cancer (stage III-IV), Colorectal adenocarcinoma (stage III-IV), and Breast Cancer (stage III-IV), as per inclusion/exclusion criteria. Approximately 470 total patients will be enrolled into the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Guardant360
Diagnostic testGuardant360 is a qualitative next generation sequencing (NGS)-based in vitro diagnostic device for detection of single nucleotide variants (SNVs), insertions and deletions (indels), copy number amplifications (CNAs), and fusions in genes frequently mutated in cancer, using circulating cell-free DNA (cfDNA) obtained from the plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes.
Treatment groups
470 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort 1: Unresectable Stage III/IV NSCLC1 intervention
Group B: Cohort 2: Stage IV Colorectal1 intervention
Group C: Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2-1 intervention
Group D: Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+1 intervention
Group E: Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+1 intervention
Group F: Cohort 6: Unresectable Stage III/IV Breast - Triple Negative1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of ctDNA to Detect Disease Progression
The Primary Endpoint, sensitivity of ctDNA to detect disease progression, will be evaluated from all eligible subjects within the primary study cohorts (breast cancer, NSCLC, or CRC)
Time frame
6 yearsSecondary outcomes
1
RECIST Response
RECIST v1.1 response: defined as the tumor response to treatment as measured by restaging scans in subjects who have increasing or decreasing ctDNA quantities before the time of scan and correlating this change with the clinical response
Time frame
6 years2
Progression-Free Survival (PFS)
PFS: defined as the quantitative changes in ctDNA that correlate or associate with participant's progression free survival on each line of SOC therapy
Time frame
6 years3
Lead Time
Lead time: defined as the interval between ctDNA detection or increase and clinical detection of disease progression
Time frame
6 yearsSponsors and contacts
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Source ClinicalTrials.gov