Liquid Biopsy for Lung Cancer

Overseen By Nathan Pennell, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Prior therapy, Prior molecular testing

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if liquid biopsies can expedite treatment initiation for individuals with non-small cell lung cancer (NSCLC). A liquid biopsy, a blood test that detects cancer cells, may enable quicker treatment decisions. The trial seeks participants recently diagnosed with advanced NSCLC who have not yet received treatment or genetic test results. Participants should plan to receive treatment at the Cleveland Clinic or have some follow-up there. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future cancer care.

Do I need to stop my current medications for the trial?

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

What prior data suggests that this liquid biopsy is safe for use in patients with non-small cell lung cancer?

Research shows that patients generally find liquid biopsy easy to handle. This method uses a simple blood test to detect cancer cells, making it much less invasive than traditional biopsies. Studies have shown that it is safe and poses minimal risk to patients.

No major side effects have been reported when using liquid biopsies for non-small cell lung cancer (NSCLC). The procedure avoids surgery or major interventions, reducing the chance of complications. Overall, liquid biopsies are considered a safe option for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about liquid biopsy for lung cancer because it offers a non-invasive way to detect cancer cells through a simple blood test. Unlike traditional biopsies that require surgical procedures to obtain tissue samples, liquid biopsies are less risky and can be performed more frequently. This approach allows for real-time monitoring of cancer progression and response to treatment, potentially leading to more personalized and timely interventions.

What evidence suggests that a liquid biopsy is effective for reducing time to begin treatment in NSCLC?

Research has shown that liquid biopsies can identify important genetic changes in non-small cell lung cancer (NSCLC). This method uses blood samples instead of tissue samples, leading to faster test results and quicker treatment decisions. Studies indicate that liquid biopsies more successfully obtain usable samples compared to traditional methods. Early evidence also suggests they can detect cancer changes that other tests might miss. This makes liquid biopsies a promising tool for faster and more accurate cancer detection. ^{6 7 8 9 10}

Who Is on the Research Team?

Nathan A. Pennell

Principal Investigator

Cleveland Clinic, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for new patients with advanced nonsquamous non-small cell lung cancer (NSCLC) who plan to receive systemic therapy and are referred to the Cleveland Clinic Taussig Cancer Center without prior genetic testing results. It's not open to those who've had previous treatment or adequate molecular testing for their current NSCLC diagnosis.

Inclusion Criteria

I plan to get my treatment at Cleveland Clinic or another site but will follow up or share my records with Cleveland Clinic.

I have advanced non-squamous NSCLC and was referred to the Cleveland Clinic without prior genetic testing results.

Exclusion Criteria

You have already had the necessary genetic testing for your lung cancer diagnosis.

I have received treatment for non-small cell lung cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Liquid Biopsy Testing

Participants undergo liquid biopsy testing to detect cancer cells and actionable genetic markers

1 week

1 visit (in-person)

Treatment

Participants receive guideline-directed therapy based on liquid biopsy results

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liquid biopsy

Trial Overview The study is examining whether liquid biopsies can speed up the start of treatment in advanced NSCLC patients. A liquid biopsy involves taking a blood sample to search for cancer cells, which may help in quicker decision-making regarding therapy.

How Is the Trial Designed?

Group I: Liquid biopsy Experimental Treatment 1 Intervention

A liquid biopsy is a test will be done on a sample of blood to look for cancer cells

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11505603/

Implementation of Liquid Biopsy in Non-Small-Cell Lung ... Prognosis for NSCLC is poor with a 5-year survival rate below 20%, owing to its aggressive nature and large proportion of patients presenting ...

2. nature.com nature.com/articles/s43856-025-01068-2

Liquid biopsy diagnostics for non-small cell lung cancer via ... NSCLC presents a high risk for early metastasis, contributing to a grim five-year survival rate of merely 28% within the U.S. population. These ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e20536

Accelerating treatment decisions with liquid biopsy NGS in ... Liquid biopsy demonstrated other significant advantages over tissue NGS, including faster TAT, shorter TtT, and higher sample success rates.

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13786-w

Efficacy of liquid biopsy for genetic mutations determination in ... A growing body of evidence suggests that liquid biopsy can accurately detect a wide range of genetic alterations in lung cancer, including key ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2950195423000012

Liquid biopsy in detecting early non-small cell lung cancer Lung cancer screening programs, particularly in the UK, have shown a decrease in lung cancer-related deaths among individuals who underwent low-dose ...

6. nature.com nature.com/articles/s41392-024-02021-w

Liquid biopsy in cancer: current status, challenges and ... The exosome, which is currently popular in liquid biopsies, has likewise been found to serve as a liquid biopsy biomarker for lung cancer.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9917347/

Liquid Biopsy for Lung Cancer: Up-to-Date and ... Liquid biopsy is a minimally invasive approach to determine biomarkers from body fluids, such as blood, urine, sputum, and saliva.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9161665/

Real-World Data on Liquid Biopsy Use in Non-Small Cell ... Integration of liquid biopsy into the routine management of patients with non-small cell lung cancer demonstrated AA detection in 44 additional patients, which ...

9. jto.org jto.org/article/S1556-0864(21)02284-X/fulltext

Liquid Biopsy for Advanced NSCLC: A Consensus ... Liquid biopsy for advanced NSCLC: A consensus statement from the International Association for the Study of Lung Cancer.

10. mdpi.com mdpi.com/2072-6694/17/21/3474

Liquid Biopsy in Lung Cancer: Tracking Resistance to ... Pivotal ARROS-1 Efficacy and Safety Data: Zidesamtinib in TKI Pretreated Patients with Advanced/Metastatic ROS1+ NSCLC. In Proceedings of the International ...