Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Collection of Peripheral Blood and Lung Lesion Samples From Participants With Suspected Lung Cancer to Examine the Potential of Bronchoscopic Biopsies to Assess Non-small Cell Lung Cancer (NSCLC) Tumor Immune Subtypes and Related Biomarkers
Verified date | June 2023 |
Source | Janssen Research & Development, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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]).
Status | Completed |
Enrollment | 33 |
Est. completion date | May 12, 2023 |
Est. primary completion date | May 12, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Presence of one or more radiographically identified 1-5 centimeter (cm) solid or sub-solid lung lesions with at least a 1 cm solid component highly suspicious for lung cancer and requiring bronchoscopic diagnosis, with a computed tomography (CT) scan or other cross-sectional imaging (example, CT-positron emission tomography [PET]) within 28 days of the intended bronchoscopy - Deemed by the investigator(s), including thoracic surgeon, to be a suitable candidate for surgical resection with curative intent, following review of participant information which may include past medical history, medications, pulmonary function testing, and CT scan - Able to tolerate general anesthesia and a diagnostic bronchoscopy, as assessed by the investigator - Each participant (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and the procedures required for the study and are willing to participate in the study Exclusion Criteria: - Participants who are currently receiving, have received within the last 6 months, or plan to receive any systemic treatment for their presumed lung cancer between Screening visit and the last blood sample collection at Week 6 visit - Participants who have previously received radiation therapy to the lung (example, radiation therapy to chest wall, such as for breast cancer is allowed) - Participants who are currently receiving systemic steroids or other immunosuppressive medications (example, methotrexate, azathioprine, anti- tumor necrosis factor [TNF] agents), have received these medications within 6 weeks prior to bronchoscopic biopsy, or who plan to receive these medications between Screening visit and last blood sample collection at Week 6 visit. Periprocedural low dose systemic steroids may be given during bronchoscopy and surgical resection procedures per institutional standard of care (SOC) but cannot be administered before blood samples have been collected. Use of inhaled or other topical corticosteroids (example, otic, ocular, skin) is permitted - Participants with uncorrectable coagulopathy (example, hemophilia, disseminated intravascular coagulation [DIC], massive pulmonary embolism [PE]) or with therapeutic anticoagulant that cannot be held for an appropriate interval prior to the procedure - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or physical limitations that could prevent, limit, or confound the protocol-specified assessments |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Comprehensive Cancer Center | Buffalo | New York |
United States | Medstar Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to Week 6 | |
Secondary | 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. | Up to 6 Weeks | |
Secondary | Tumor Mutational Burden Assessed by Next Generation Sequencing | Sequencing nucleic acids by next generation sequencing will be used to calculate tumor mutational burden. | Up to 6 Weeks | |
Secondary | 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. | Up to 6 Weeks | |
Secondary | T-cell Receptor (TCR) Repertoire Sequencing in Tumor | T cell receptor (TCR) sequencing in tumor samples will be reported. | Up to 6 Weeks |
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