Non-small Cell Lung CancerNCT05935384
SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
An observational study of Non-small Cell Lung Cancer and Colorectal Cancer, run by Guardant Health, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Colorectal Cancer, Breast Cancer
- What is being tested?
- Guardant360
- How many people
- 470 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Each participant must satisfy all the following criteria to be enrolled in the study:
- 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
- Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent
Show all 14Show fewer
- Are willing to provide blood samples at enrollment and at subsequent clinical visits
- Have a histologically confirmed Index cancer that qualifies for inclusion, defined as:
- Cohort 1: Unresectable Stage III/IV NSCLC (~125)
- Cohort 2: Stage IV Colorectal (~125)
- Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- (~55)
- Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ (~55)
- Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ (~55)
- Cohort 6: Unresectable Stage III/IV Breast - Triple Negative (~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage.
Who cannot join
- Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study:
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077-1384
Ira Oliff
About this study
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.
- Conditions
- Non-small Cell Lung Cancer, Colorectal Cancer, Breast Cancer
- Being tested
- Guardant360
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardant360Diagnostic test
Guardant360 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Unresectable Stage III/IV NSCLC | Blood samples collected will be banked Receives: Diagnostic Test: Guardant360 | |
| Cohort 2: Stage IV Colorectal | Blood samples collected will be banked Receives: Diagnostic Test: Guardant360 | |
| Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- | Blood samples collected will be banked Receives: Diagnostic Test: Guardant360 | |
| Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ | Blood samples collected will be banked Receives: Diagnostic Test: Guardant360 | |
| Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ | Blood samples collected will be banked Receives: Diagnostic Test: Guardant360 | |
| Cohort 6: Unresectable Stage III/IV Breast - Triple Negative | Blood samples collected will be banked Receives: Diagnostic Test: Guardant360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 years
Secondary outcomes (3)
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
Measured: 6 years
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
Measured: 6 years
Lead Time
Lead time: defined as the interval between ctDNA detection or increase and clinical detection of disease progression
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start25 Oct 2023
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guardant Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935384
- Sponsor's protocol ID
- 06-MX-001
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
- ClinicalTrials.gov ID
- NCT05935384
- Acronym / sponsor ID
- 06-MX-001
- Conditions
- Non-small Cell Lung Cancer, Colorectal Cancer, Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Guardant Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 7 Jul 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Unresectable Stage III/IV NSCLC | – | Diagnostic Test: Guardant360Blood samples collected will be banked |
| Cohort 2: Stage IV Colorectal | – | Diagnostic Test: Guardant360Blood samples collected will be banked |
| Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- | – | Diagnostic Test: Guardant360Blood samples collected will be banked |
| Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ | – | Diagnostic Test: Guardant360Blood samples collected will be banked |
| Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ | – | Diagnostic Test: Guardant360Blood samples collected will be banked |
| Cohort 6: Unresectable Stage III/IV Breast - Triple Negative | – | Diagnostic Test: Guardant360Blood samples collected will be banked |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (14 listed)
- 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
- Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent
Key exclusion criteria (5 listed)
- Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guardant360Guardant360 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. | Diagnostic test | Cohort 1: Unresectable Stage III/IV NSCLC, Cohort 2: Stage IV Colorectal, Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2-, Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+, Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+, Cohort 6: Unresectable Stage III/IV Breast - Triple Negative |
Primary outcome
Sensitivity of ctDNA to Detect Disease Progression
Time frame: 6 years
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)
3 secondary outcomes
RECIST Response
Time frame: 6 years
Progression-Free Survival (PFS)
Time frame: 6 years
Lead Time
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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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.
1 site 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 and Colorectal Cancer, run by Guardant Health, Inc. at 1 site 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 14 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Operations (8556988887, sibyl@guardanthealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of ctDNA to Detect Disease Progression (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.