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| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODLUC0002 | Other Identifier | Janssen Research & Development, LLC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoscopic Biopsy | Other | Bronchoscopic biopsies will be used to evaluate biomarkers of tumor biology and immunology. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Tumor Mutational Burden Assessed by Next Generation Sequencing |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include participants with a radiographically identified lung lesion that is highly suspicious for lung cancer that has been deemed likely to be resectable.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Roswell Park Comprehensive Cancer Center |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood Sample | Other | Blood samples will be obtained to measure circulating biomarkers. |
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Sequencing nucleic acids by next generation sequencing will be used to calculate tumor mutational burden. |
| 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. | Up to 6 Weeks |
| T-cell Receptor (TCR) Repertoire Sequencing in Tumor | T cell receptor (TCR) sequencing in tumor samples will be reported. | Up to 6 Weeks |
| Buffalo |
| New York |
| 14263 |
| United States |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |