Guardant360 for Advanced Lung Cancer

Overseen ByClinical Trial Operations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Guardant Health, Inc.

Disqualifiers: Prior malignancy, Life expectancy, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively the blood test Guardant360 tracks responses in patients with advanced solid tumors. The focus is on determining if changes in blood test results align with treatment effectiveness, particularly when compared to standard methods like CT scans. Participants are needed from various groups, including those with advanced breast, lung, and colorectal cancer who are starting or changing treatments. Individuals with advanced stages of these cancers, currently undergoing or about to begin systemic therapy, might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant findings.

Will I have to stop taking my current medications?

The trial requires participants to be on a systemic therapy or oral standard of care (SOC) regimen during the study, so you will not need to stop taking your current medications if they are part of your treatment plan.

What prior data suggests that the Guardant360 is safe for measuring response to systemic therapy in patients with unresectable advanced solid tumors?

Research has shown that the FDA has approved Guardant360. This approval allows its use with certain cancer treatments to aid in treatment decisions, indicating the test's general safety.

Studies have found that patients tolerate Guardant360 well, with no major safety issues reported. Most side effects, if any, are mild. Common ones include nausea and muscle or bone pain, similar to those seen with other treatments for advanced cancer.

Overall, the safety profile of Guardant360 aligns with other tests and treatments in its category. The test involves a blood draw, a routine and safe procedure.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Researchers are excited about the SIBYL trial because it looks at how well liquid biopsies can gauge treatment responses for tough-to-treat cancers like advanced breast cancer and colorectal cancer. Unlike traditional biopsies that require tissue samples, liquid biopsies are non-invasive and involve just a simple blood draw. This method could provide quicker, easier, and more frequent insights into how a cancer is responding to treatment, potentially leading to more personalized and effective care plans for patients.

What evidence suggests that Guardant360 is effective for monitoring response to systemic therapy in patients with advanced solid tumors?

Research shows that Guardant360, a blood test, effectively tracks treatment progress in patients with advanced solid tumors by analyzing tiny pieces of tumor DNA in the blood. Studies have found that changes in these DNA levels indicate how well a patient responds to therapy. For example, in breast cancer, these DNA changes link to treatment outcomes, allowing for more personalized care. Guardant360 also identifies genetic changes in tumors, aiding doctors in making informed treatment decisions. This makes it a promising tool for real-time treatment effectiveness monitoring. Participants in this trial will have blood samples collected and banked for analysis using Guardant360 across various cohorts, including those with unresectable Stage III/IV breast cancer and other advanced solid tumors.⁶ ⁷ ⁸ ⁹ ¹⁰

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

I am receiving standard treatment throughout the study.

I have not started or have completed my first round of standard cancer treatment.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive systemic therapy for unresectable advanced solid tumors, with blood samples collected for ctDNA analysis

6 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, with ctDNA dynamics correlated with therapeutic response

6 years

What Are the Treatments Tested in This Trial?

Interventions

Guardant360

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Group I: Cohort 6: Unresectable Stage III/IV Breast - Triple NegativeExperimental Treatment1 Intervention