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

Last updated: June 5, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Platinum Doublet Chemotherapy

Pembrolizumab

Circulating Tumor Deoxyribonucleic acid (ctDNA) Assay

Clinical Study ID

NCT06902272
20240140
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Eligible participants must be males or females ≥18 years of age on day of signingthe informed consent form.

  2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

  3. Participants with histologically confirmed Stage IB (≥4 cm), II, or IIIB (N2) NSCLC (as per the 8th American Joint Committee on Cancer (AJCC)) who are consideredresectable by a multidisciplinary team and who are going to be treated withneoadjuvant treatment including chemotherapy, immunotherapy, and in some casesradiation before surgery

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

  5. Participants must have tumor tissue available for programmed cell death ligand 1 (PD-L1) immunohistochemical (IHC) testing performed by a third-party analyzing labduring the screening period:

  6. Either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstainedtumor tissue sections, with an associated pathology report, must be submittedfor biomarker evaluation prior to randomization. The tumor tissue sample may befresh or archival if obtained within 6 months prior to enrollment

  7. Tissue must be a core needle biopsy, excisional or incisional biopsy. Fineneedle biopsies obtained by endobronchial ultrasound (EBUS) are not consideredadequate for biomarker review and randomization. Core needle biopsies obtainedby EBUS are acceptable for randomization.

Exclusion

Exclusion Criteria:

  1. Presence of locally advanced, unresectable, or metastatic disease. Mediastinal lymphnode samples at levels 4 (bilaterally) and 7 are required for clinical staging toassess nodal involvement in participants with mediastinal adenopathy on positronemission tomography-computed tomography scan (PET/CT).

  2. Participants with known epidermal growth factor receptor (EGFR) mutations oranaplastic lymphoma kinase (ALK) translocation

  3. Previous exposure to anti-cancer therapy, including chemotherapy, radiotherapy orimmunotherapy, and previous exposure to immunosuppressive drugs within 3 weeksbefore neoadjuvant treatment

  4. Participants with impaired decision-making capacity .

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Platinum Doublet Chemotherapy
Phase: 2
Study Start date:
August 01, 2025
Estimated Completion Date:
August 01, 2029

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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