NCT04951154

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[NSCLC\]).

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).

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
OTHER	Bronchoscopic Biopsy	Bronchoscopic biopsies will be used to evaluate biomarkers of tumor biology and immunology.
OTHER	Blood Sample	Blood samples will be obtained to measure circulating biomarkers.

Timeline

• Start date: 2022-03-28
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2021-07-06
• Last updated: 2025-08-19

Locations

2 sites across 1 country: United States