A Study to Examine Biomarkers From Lung and Blood Samples in Participants With Suspected Lung Cancer
Study Details
Study Description
Brief Summary
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]).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants with Suspected Lung Cancer Eligible participants with suspected lung cancer will be enrolled and undergo diagnostic and research bronchoscopic biopsies and research blood sample collection for biomarker analysis. Those participants who proceed to surgical resection will have additional research samples taken from the resected tumor and additional research blood samples drawn for biomarker analyses at the resection visit and at the post-operative follow up visit. Participants will then be followed clinically for two years for evidence of recurrence or until participants with confirmed lung cancer recurrence, whichever occurs earlier. |
Other: Bronchoscopic Biopsy
Bronchoscopic biopsies will be used to evaluate biomarkers of tumor biology and immunology.
Other Names:
Other: Blood Sample
Blood samples will be obtained to measure circulating biomarkers.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Percent of Residual Viable Tumor Cells (% RVT) at the Time of Non-small Cell Lung Cancer (NSCLC) Resection [Up to Week 6]
Percent of RVT cells at the time of NSCLC resection will be reported.
Secondary Outcome Measures
- Tumor Gene Expression Analysis by Ribonucleic Acid (RNA)-sequencing or Polymerase Chain Reaction (PCR) Techniques [Up to 6 Weeks]
RNA sequencing or PCR techniques will be used to assess tumor gene expression.
- Tumor Mutational Burden Assessed by Next Generation Sequencing [Up to 6 Weeks]
Sequencing nucleic acids by next generation sequencing will be used to calculate tumor mutational burden.
- Tissue Frequencies of Immune Cell Subsets Determined via Semi-quantitative Immunofluorescence and/or Imaging Mass Cytometry [Up to 6 Weeks]
Percentage of immune cell subsets measured using immunofluorescence and/or imaging mass cytometry will be reported.
- T-cell Receptor (TCR) Repertoire Sequencing in Tumor [Up to 6 Weeks]
T cell receptor (TCR) sequencing in tumor samples will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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
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Able to tolerate general anesthesia and a diagnostic bronchoscopy, as assessed by the investigator
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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:
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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
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Participants who have previously received radiation therapy to the lung (example, radiation therapy to chest wall, such as for breast cancer is allowed)
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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
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UConn Health Center | Farmington | Connecticut | United States | 06030 |
| 2 | Medstar Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 3 | Minnesota Lung Center | Minneapolis | Minnesota | United States | 55407 |
| 4 | Roswell Park Comprehensive Cancer Center | Buffalo | New York | United States | 14263 |
| 5 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109030
- NOPRODLUC0002