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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04951154
• Other study ID #: CR109030
• Secondary ID: NOPRODLUC0002
• Status: Completed
• Start date: March 28, 2022
• Est. completion date: May 12, 2023

Study information

• Verified date: June 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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]).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Other:
• Bronchoscopic Biopsy
Bronchoscopic biopsies will be used to evaluate biomarkers of tumor biology and immunology.
• Blood Sample
Blood samples will be obtained to measure circulating biomarkers.

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Tumor Mutational Burden Assessed by Next Generation Sequencing	Sequencing nucleic acids by next generation sequencing will be used to calculate tumor mutational burden.	Up to 6 Weeks
Secondary	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
Secondary	T-cell Receptor (TCR) Repertoire Sequencing in Tumor	T cell receptor (TCR) sequencing in tumor samples will be reported.	Up to 6 Weeks