Low-dose CT Scan for Lung Cancer

(SHIELD Trial)

Not currently recruiting at 173 trial locations

Overseen By Ha Nguyen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Guardant Health, Inc.

Must not be taking: Anti-neoplastic, DMARDs

Disqualifiers: Lung cancer, High-risk lung lesion, others

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

Compensation: Varies

Number of Visits: 4

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 GuardantLUNAR-2 detects cancer in individuals at high risk. It specifically targets those undergoing routine lung cancer screenings with low-dose CT scans. Suitable candidates include current or recent smokers (those who quit within the last 15 years) with a history of smoking at least 20 pack-years (an average of one pack a day for 20 years). Participants must agree to a blood draw during their CT scan visit and commit to a year-long follow-up. As a Phase 2 trial, this research measures the blood test's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer detection.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking anti-cancer or certain immune-modifying drugs, you may not be eligible to participate.

What prior data suggests that the GuardantLUNAR-2 test and low-dose CT scan are safe for lung cancer screening?

Research shows that the GuardantLUNAR-2 test is generally easy for people to handle because it is just a blood test. Blood tests are common and safe, and no specific problems have been reported with the GuardantLUNAR-2 test.

The low-dose CT scan is a regular part of lung cancer screening. Studies indicate it is safe and effective for detecting lung cancer in high-risk individuals. Although it uses a small amount of radiation, this is considered safe for regular check-ups.

Overall, available research indicates that both the blood test and the low-dose CT scan are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GuardantLUNAR-2 test because it offers a non-invasive way to screen for lung cancer by analyzing blood samples, potentially making early detection easier and more accessible. Unlike traditional low-dose CT scans, which require imaging equipment and radiation exposure, this blood test could provide a simpler, safer, and quicker alternative. By identifying cancer-related signals in the blood, the GuardantLUNAR-2 test aims to catch lung cancer at an earlier stage, which could significantly improve treatment outcomes.

What evidence suggests that the GuardantLUNAR-2 test and low-dose CT scan are effective for detecting high frequency cancer?

Research has shown that the GuardantLUNAR-2 test holds promise for detecting cancer. In earlier studies, this blood test correctly identified 76.3% of 12 specific types of cancer. For early-stage cancers, it detected 53.5% of stage I–II cases, indicating its potential to find cancer early, which is crucial for successful treatment. In this trial, participants in the Lung Cancer Screening Cohort will undergo standard low-dose CT scanning according to guidelines, and an investigational blood draw will evaluate the GuardantLUNAR-2 test's effectiveness in early lung cancer detection. Although more research is needed, these results suggest it could be a valuable tool for early cancer detection, including lung cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Hannah Oakley

Principal Investigator

Guardant Health, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects aged 50-80 years at time of consent

Increased risk of lung cancer defined by: at least 20 pack-year smoking history and currently smoke or have quit within the past 15 years

Willing to consent to the investigational blood draw during index LDCT screening visit and before any invasive procedures or treatment for lung cancer diagnosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 90 days

1 visit (in-person)

Initial Assessment

Participants undergo standard of care screening and investigational blood draw

1 day

1 visit (in-person)

Follow-up

Participants are monitored with follow-up visits at 1 year and 2 years for updated medical data and repeat investigational blood draw

24 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• GuardantLUNAR-2 test
• Low-dose CT scan

How Is the Trial Designed?

Group I: Lung Cancer Screening Cohort Experimental Treatment 1 Intervention

Individuals at high-risk of lung cancer undergoing standard of care screening as per USPSTF guidelines. All subjects will undergo low-dose CT scanning as per guidelines and an investigational blood-draw will be taken from all enrolled subjects.

Who Is Running the Clinical Trial?

Guardant Health, Inc.

Lead Sponsor

Trials

22

Recruited

66,900+

Citations

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

Updates on lung cancer screening for early detection - PMC For 12 pre-specified cancers, the test achieved an overall sensitivity of 76.3% across all stages, including 53.5% for stages I–II and 67.6% for ...

2. 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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05117840

Screening for High Frequency Malignant Disease (SHIELD) The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT367146

Screening for high frequency malignant disease (SHIELD). The study's primary objective is to evaluate the performance of a blood-based multi-cancer screening test (GuardantLUNAR-2, Guardant Health, USA) to detect ...

5. researchgate.net researchgate.net/publication/371294991_Screening_for_high_frequency_malignant_disease_SHIELD

Screening for high frequency malignant disease (SHIELD). The study's primary objective is to evaluate the performance of a blood-based multi-cancer screening test (GuardantLUNAR-2, Guardant Health, US) ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230009B.pdf

summary of safety and effectiveness data (ssed) This test is performed at Guardant Health, Inc. III. PRECAUTION. Based on data from clinical studies, Shield has limited detection (55%-65%) of Stage I.

7. starlingphysicians.com starlingphysicians.com/lunar-2/

GUARDANT LUNAR-2 TEST A blood test that seeks to increase screening rates and overcome the challenges of current methods, all from a simple blood draw.

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

Guardant Complete® for Early and Advanced Stage Cancer Guardant Reveal is a simple blood test that utilizes circulating tumor DNA (ctDNA) to detect cancer at the molecular level, offering a more precise, ctDNA- ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11498919/

Current Evidence for a Lung Cancer Screening Program - PMC ... Guardant LUNAR-2 test to detect high-frequency cancer in screen-relevant populations. LUNAR-2 is a multimodal ctDNA blood test. The SHIELD study will ...