Phase
Condition
N/ATreatment
Platinum Doublet Chemotherapy
Pembrolizumab
Circulating Tumor Deoxyribonucleic acid (ctDNA) Assay
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Eligible participants must be males or females ≥18 years of age on day of signingthe informed consent form.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
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
Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
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:
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
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:
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).
Participants with known epidermal growth factor receptor (EGFR) mutations oranaplastic lymphoma kinase (ALK) translocation
Previous exposure to anti-cancer therapy, including chemotherapy, radiotherapy orimmunotherapy, and previous exposure to immunosuppressive drugs within 3 weeksbefore neoadjuvant treatment
Participants with impaired decision-making capacity .
Study Design
Connect with a study center
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
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