The purpose of this study is to assess spontaneous residual viable tumor cells (RVT) in the surgically resected tumor (Non-small cell lung cancer \[NSCLC\]).
This is a multicenter study including participants with a radiographically identified lung lesion that is highly suspicious for lung cancer that has been deemed likely to be resectable. After confirmation of a NSCLC diagnosis and eligibility for surgical resection with curative intent, participants will undergo surgical resection of their tumor. Participants will complete a follow up visit approximately 2-4 weeks after their surgery. During this initial period of the study, blood and tissue samples will be collected for biomarker analyses. Participants will then receive a follow up telephone call every 6 months for up to an additional 2 years, or until participants with confirmed lung cancer recurrence, whichever occurs earlier, to document any instances of disease recurrence. Therefore, a key objective of this study is to achieve a more detailed understanding of how representative these pretreatment bronchoscopic biopsies are of the resected tumor sample, hence, no investigational new treatments will be given to the participants enrolled in this study. Safety will be evaluated by monitoring of procedure-related adverse events (AEs) and serious adverse events (SAEs). The total duration of the study will be approximately 2 years and 3 months (actual duration of participation will be dependent upon timing of scheduling of bronchoscopy and surgical resection and timing of cancer recurrence, if applicable).
Study Type
OBSERVATIONAL
Enrollment
33
Bronchoscopic biopsies will be used to evaluate biomarkers of tumor biology and immunology.
Blood samples will be obtained to measure circulating biomarkers.
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Percent of Residual Viable Tumor Cells (% RVT) at the Time of Non-small Cell Lung Cancer (NSCLC) Resection
Percent of RVT cells at the time of NSCLC resection will be reported.
Time frame: Up to Week 6
Tumor Gene Expression Analysis by Ribonucleic Acid (RNA)-sequencing or Polymerase Chain Reaction (PCR) Techniques
RNA sequencing or PCR techniques will be used to assess tumor gene expression.
Time frame: Up to 6 Weeks
Tumor Mutational Burden Assessed by Next Generation Sequencing
Sequencing nucleic acids by next generation sequencing will be used to calculate tumor mutational burden.
Time frame: Up to 6 Weeks
Tissue Frequencies of Immune Cell Subsets Determined via Semi-quantitative Immunofluorescence and/or Imaging Mass Cytometry
Percentage of immune cell subsets measured using immunofluorescence and/or imaging mass cytometry will be reported.
Time frame: Up to 6 Weeks
T-cell Receptor (TCR) Repertoire Sequencing in Tumor
T cell receptor (TCR) sequencing in tumor samples will be reported.
Time frame: Up to 6 Weeks
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