A Study to Examine Biomarkers From Lung and Blood Samples in Participants With Suspected Lung Cancer

NCT04951154 | Completed

• 2 other identifiers: CR109030NOPRODLUC0002
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 2

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 \[NSCLC\]).

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Tumor Gene Expression Analysis by Ribonucleic Acid (RNA)-sequencing or Polymerase Chain Reaction (PCR) Techniques

  Up to 6 Weeks

• Tumor Mutational Burden Assessed by Next Generation Sequencing

  Up to 6 Weeks

• Tissue Frequencies of Immune Cell Subsets Determined via Semi-quantitative Immunofluorescence and/or Imaging Mass Cytometry

  Up to 6 Weeks

• T-cell Receptor (TCR) Repertoire Sequencing in Tumor

  Up to 6 Weeks

Study Arms (1)

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; Other: Blood Sample

Interventions

Bronchoscopic Biopsy OTHER

Bronchoscopic biopsies will be used to evaluate biomarkers of tumor biology and immunology.

Also known as: No investigational product will be administered in this study.

Participants with Suspected Lung Cancer

Blood Sample OTHER

Blood samples will be obtained to measure circulating biomarkers.

Also known as: No investigational product will be administered in this study.

Participants with Suspected Lung Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 6, 2021
• Study Start: March 28, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)