ctDNA to Predict Response to Chemo-Immunotherapy in Non-Small Cell Lung Cancer
This study is looking at whether a blood test called circulating tumor DNA (ctDNA) can predict how well people with non-small cell lung cancer (NSCLC) will respond to treatment. It also aims to see if ctDNA can detect any cancer remaining after surgery. Participants will receive standard treatments: Pembrolizumab (an immunotherapy drug) and platinum doublet chemotherapy before surgery. Researchers will also study if Pembrolizumab can help prevent cancer from returning in patients who still have ctDNA or cancer after initial treatment and surgery. You may be eligible if you are 18 or older, have Stage IB, II, or IIIB NSCLC that can be surgically removed, and meet other health criteria. The study aims to enroll 30 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 30 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will have blood samples taken for ctDNA testing at screening, during treatment, and after surgery. You will receive Pembrolizumab and platinum doublet chemotherapy for up to four cycles before surgery, and possibly Pembrolizumab after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures changes in ctDNA clearance and pathologic complete response up to 3 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ctDNA to Predict Response to Chemo-Immunotherapy and Detect Minimal Residual Disease in Non-Small Cell Lung Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Richa Dawar, MD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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What this trial measures
- Change in ctDNA Clearance: Neoadjuvant Phase Measured by Percentage of ParticipantsBaseline, 3 months
ctDNA clearance is defined as change from detectable ctDNA at start of neoadjuvant treatment to no detectable ctDNA at the end of neoadjuvant treatment or prior to surgery. The percentage of participants experiencing ctDNA clearance will be reported.
- Pathologic Complete Response (pCR) As Measured By Percentage of ParticipantsUp to 3 months
Pathologic Complete Response (pCR) is defined as percentage of participants who underwent surgery after neoadjuvant therapy with 0% viable tumor in resected lung and lymph nodes.