Guardant Health ct-DNA Assay for Lung Cancer

Recruiting at 2 trial locations

Overseen By Mehrdad Arjomandi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Active cancer, Anemia, Malnourishment, Severe COPD, Unstable heart, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

590 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the Guardant Health ct-DNA LUNAR assay can detect lung cancer risks by analyzing DNA fragments in the blood. Researchers aim to evaluate the test's effectiveness in individuals with various lung conditions, such as those with suspicious nodules or those previously treated for lung cancer. The trial includes groups with benign nodules or presumed lung cancer, both before and after treatment. Suitable participants have lung nodules or a history of lung cancer and are willing to provide blood samples and follow up for three years.

As a Phase 2 trial, this research focuses on assessing the test's performance in an initial, smaller group, offering participants a chance to contribute to significant advancements in lung cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that the Guardant Health ct-DNA LUNAR assay is safe?

Research shows that the Guardant Health ct-DNA LUNAR test is generally easy for people to handle. This blood test checks for cancer at a very detailed level and is designed to be less invasive than traditional methods like CT scans.

Studies suggest that this type of liquid biopsy, which uses a blood sample to detect cancer, usually doesn't cause side effects because it involves only a simple blood draw. No major negative effects have been reported in previous uses of similar tests for cancer detection, indicating that people generally do not experience harmful effects from the test itself.

Additionally, this kind of blood test is already approved and used for detecting other types of cancer, providing some confidence in its safety. However, any medical test can have risks, so discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Guardant Health ct-DNA LUNAR assay is unique because it uses a non-invasive liquid biopsy method to detect lung cancer biomarkers in circulating tumor DNA (ct-DNA) from a simple blood draw. Unlike traditional methods like tissue biopsy, which can be invasive and risky, this assay aims to offer a quicker and safer way to assess lung cancer risk and monitor treatment response. Researchers are excited about this approach because it has the potential to identify cancer earlier and track disease progression with less discomfort for patients.

What evidence suggests that the Guardant Health ct-DNA LUNAR assay is effective for lung cancer screening?

Research shows that the Guardant Health ct-DNA LUNAR test, used in this trial, holds promise for early lung cancer detection. This test identifies tiny pieces of tumor DNA in the blood, potentially revealing cancer even when scans do not. Studies have demonstrated that this type of blood test, known as a liquid biopsy, can detect lung cancer in its early stages, facilitating treatment. The test has also been successful with other cancer types, indicating its potential for early detection across various cancers. While further research will confirm its effectiveness, initial results are encouraging for early lung cancer detection. ^{1 2 3 5 6}

Who Is on the Research Team?

Mehrdad Arjomandi, M.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

Age ≥ 40 years

Ability to understand and provide written informed consent

Willingness to comply with study protocols and provide blood samples.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sensitivity and Specificity Thresholding

Technical feasibility of the ctDNA assay is assessed in patients with known cancer status.

3 years

Multiple visits for CT screening follow-up

Clinical Intended Use Performance

Clinical performance of the ctDNA assay is evaluated in patients with high clinical suspicion for lung cancer.

3 years

Multiple visits for CT screening and clinical follow-up

Follow-up

Participants are monitored for safety and effectiveness after the main observational study phases.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Guardant Health ct-DNA LUNAR assay

How Is the Trial Designed?

Group I: Cohort IC: Presumed lung cancer Experimental Treatment 1 Intervention

Patients with lung cancer (histologically proven or presumed by consensus opinion of tumor board); prior to definitive therapy. 1- Age ≥40 years.

Group II: Cohort 2C: Post-treatment lung cancer Experimental Treatment 1 Intervention

Patients with previously treated lung cancer (histologically proven or by consensus opinion); status-post completion of definitive therapy (resection +/- chemotherapy or SBRT with curative intent) within the previous year with no current evidence of disease. 1- Age ≥40 years.

Group III: Cohort 2B: Suspicious incidental nodule Experimental Treatment 1 Intervention

Patients with newly diagnosed incidentally-found lung nodules ≥ 6 mm on routine CT evaluation deemed suspicious for malignancy by physician judgment. 1- Age ≥40 years.

Group IV: Cohort 2A: Suspicious nodule Experimental Treatment 1 Intervention

High-risk patients with newly diagnosed suspicious nodule of Lung RADS ≥3 on CT screening. 1. ≥30 pack-year history of cigarette smoking 2. ≥55 years of age 3. Current smoker or quit within the past 15 years

Group V: Cohort 1B: Incidental benign nodule Experimental Treatment 1 Intervention

Patients with lung nodules ≥ 6 mm on routine (non-lung cancer screening) CT evaluation deemed suspicious for malignancy by initial physician judgment but not malignant by ≥2 years of radiographic stability and consensus clinical opinion. 1- Age ≥40 years.

Group VI: Cohort 1A: Benign nodule on screening CT Experimental Treatment 1 Intervention

High-risk patients eligible for lung cancer screening but with negative radiographic findings on CT screening (Lung RADS ≤2). 1. ≥30 pack-year history of cigarette smoking 2. ≥55 years of age 3. Current smoker or quit within the past 15 years

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Northern California Institute of Research and Education

Collaborator

Trials

30

Recruited

10,400+

Guardant Health, Inc.

Industry Sponsor

Trials

22

Recruited

66,900+

Citations

1. guardanthealth.com guardanthealth.com/clinical-studies/

Our Cancer Screening Clinical Studies Now, the next stage is to demonstrate the same effectiveness in early detection of various other types of cancer, including breast, lung, and colorectal cancer.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03774758

Biomarkers for Risk Stratification in Lung Cancer Biospecimen Description: The goal of this study is to evaluate the ability of cell-free circulating tumor DNA (ctDNA) using Guardant Health's LUNAR technology ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12257014/

Updates on lung cancer screening for early detection - PMC This review examines the current status and recent progress in lung cancer screening programs, focusing on low-dose computed tomography (LDCT) and emerging ...

4. investors.guardanthealth.com investors.guardanthealth.com/press-releases/press-releases/2025/Guardant-Health-and-Collaborators-to-Present-New-Data-Across-the-Cancer-Care-Continuum-at-ESMO-2025/default.aspx

Press Releases Novel applications of Guardant Infinity™ in tumor profiling: data from the SIBYL study highlight the ability of molecular lung subtyping to ...

5. guardanthealth.com guardanthealth.com/products/tests-for-patients-with-early-and-advanced-stage-cancer/

Guardant Complete® for Early and Advanced Stage Cancer A comprehensive portfolio of liquid and tissue precision oncology tests for patients diagnosed with early or advanced-stage cancer.

6. guardanthealth.com guardanthealth.com/clinical-studies/shield/

SHIELD LUNG Study A simple blood test can improve lung cancer screening compliance by overcoming barriers associated with current methods, such as low-dose CT scans.