CompletedNot applicableNCT04951154

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

The purpose of this study is to assess spontaneous residual viable tumor cells (RVT) in the surgically resected tumor (Non-small cell lung cancer \[NSCLC\]).

Checked against the public recordLast updated Aug 19, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations2
SponsorJanssen Research & Development, LLC
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Janssen Research & Development, LLC
Interventions being studied
Other: Bronchoscopic Biopsy; Other: Blood Sample
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Medstar Washington Hospital CenterWashington D.C., District of Columbia
  • Roswell Park Comprehensive Cancer CenterBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 19, 2025. Always confirm current availability with the study team.

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