RecruitingPhase 2NCT06902272

ctDNA to Predict Response to Chemo-Immunotherapy and Detect Minimal Residual Disease in Non-Small Cell Lung Cancer

A Phase 2 Study of Circulating Tumor DNA to Predict Response to Neoadjuvant Treatment and De-escalation Adjuvant Immunotherapy in Early-Stage NSCLC (DNA-PREDICT)


Sponsor

University of Miami

Enrollment

30 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a blood test (ctDNA — circulating tumor DNA) to predict which non-small cell lung cancer patients will respond to a combination of chemotherapy and immunotherapy before surgery, and to detect any remaining cancer after treatment. **You may be eligible if...** - You are 18 or older with confirmed non-small cell lung cancer (NSCLC) at Stage IB (≥4 cm), II, or IIIB (N2) - Your cancer is considered resectable (surgically removable) by your medical team - You are planned to receive neoadjuvant (pre-surgery) chemotherapy and immunotherapy - Your cancer can be measured on imaging - You are in good to excellent physical health (ECOG 0-1) **You may NOT be eligible if...** - Your lung cancer has spread to the brain or other distant organs - You have an active autoimmune condition - You are pregnant or breastfeeding - You have severe organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTCirculating Tumor Deoxyribonucleic acid (ctDNA) Assay

ctDNA will be measured in participants in person via blood samples during Screening/Baseline and at the following intervals during treatment and follow-up: * During Neoadjuvant Therapy: Approximately once after four cycles of standard of care Pembrolizumab and platinum doublet therapy. * Approximately once two weeks before surgery. * Approximately once three weeks after surgery. * During Adjuvant Therapy: Approximately once every 12 weeks during standard of care, adjuvant Pembrolizumab therapy. * Follow-up Period: Approximately once every three months for up to one year.

DRUGPembrolizumab

Participants will receive standard of care, neoadjuvant Pembrolizumab therapy intravenously (IV) on Day 1 of each three-week cycle, for up to four cycles prior to standard of care surgery. After surgery, low-risk participants may continue standard of care, adjuvant Pembrolizumab therapy for up to six months; high-risk participants may receive standard of care, adjuvant Pembrolizumab therapy for up to 12 months.

DRUGPlatinum Doublet Chemotherapy

Participants will receive neoadjuvant platinum doublet chemotherapy intravenously (IV) per standard of care on Day 1 of each three-week cycle for up to four cycles, prior to standard of care surgery. Possible platinum doublet chemotherapy regimens are Cisplatin/Carboplatin in combination with Pemetrexed or Docetaxel or Gemcitabine. Participants receiving Gemcitabine therapy will be administered Gemcitabine, per standard of care, on Day 8 of each three-week cycle.


Locations(1)

University of Miami

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06902272


Related Trials