ctDNA Assay for Lung Cancer

(DNA-PREDICT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Richa Dawar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Miami

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if a blood test called circulating tumor DNA (ctDNA) can be used to predict how well patients will respond to treatment and if there is any cancer left after surgery. The investigators will also study if a drug called pembrolizumab can help prevent the cancer from coming back in patients who are ctDNA-positive or who have evidence of cancer after treatment and surgery.

Research Team

Richa Dawar, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals with non-small cell lung cancer. Participants must be suitable for chemotherapy and surgery, and willing to undergo blood tests to measure ctDNA levels. Specific eligibility criteria are not provided but typically include factors like age, overall health, and cancer stage.

Inclusion Criteria

I am fully active or have some restrictions but can still care for myself.

Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

I am 18 years or older and can sign the consent form.

Exclusion Criteria

I am unable to make my own medical decisions.

My cancer has EGFR mutations or ALK translocation.

My cancer has spread and cannot be removed by surgery.

Treatment Details

Interventions

• Pembrolizumab (Checkpoint Inhibitor)
• Platinum Doublet Chemotherapy (Chemotherapy)

Trial Overview The study aims to see if a blood test (ctDNA assay) can predict treatment response in non-small cell lung cancer patients receiving pembrolizumab and platinum doublet chemotherapy. It also examines the use of pembrolizumab in preventing cancer recurrence post-surgery in ctDNA-positive patients.

Participant Groups

Group I: ctDNA Monitoring Group Experimental Treatment 3 Interventions

Participants in this group will receive ctDNA monitoring in combination with standard of care (SOC) Pembrolizumab, SOC platinum doublet chemotherapy, and SOC surgery for resection of tumor. Total participation duration is up to 2.5 years.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal