Actively Recruiting
ctDNA to Predict Response to Chemo-Immunotherapy and Detect Minimal Residual Disease in Non-Small Cell Lung Cancer
Led by University of Miami · Updated on 2025-07-22
30
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ctDNA to Predict Response to Chemo-Immunotherapy and Detect Minimal Residual Disease in Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed Stage IB (tumor 4 cm or larger), II, or IIIB (N2) non-small cell lung cancer considered resectable by a multidisciplinary team
- Planned treatment with neoadjuvant chemotherapy, immunotherapy, and possibly radiation before surgery
- Measurable disease according to RECIST 1.1 criteria
- Availability of tumor tissue for PD-L1 immunohistochemical testing, either fresh or archival within 6 months
- Tissue sample must be from core needle biopsy, excisional or incisional biopsy; fine needle biopsies by endobronchial ultrasound (EBUS) are not adequate except for core needle biopsies obtained by EBUS
You will not qualify if you...
- Presence of locally advanced, unresectable, or metastatic disease
- Known EGFR mutations or ALK translocation
- Previous anti-cancer therapy including chemotherapy, radiotherapy, immunotherapy, or immunosuppressive drugs within 3 weeks before neoadjuvant treatment
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
R
Richa Dawar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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