Clinical trial · Observational
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
NCT04951154CI-TRIAL-00093810completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample | Other | — | UNRESOLVED |
| Bronchoscopic Biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with Suspected Lung Cancer
- description
- 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.
- interventionNames
- Other: Bronchoscopic Biopsy
- Other: Blood Sample
Primary outcomes (1)
- measure
- Percent of Residual Viable Tumor Cells (% RVT) at the Time of Non-small Cell Lung Cancer (NSCLC) Resection
- timeFrame
- Up to Week 6
- description
- Percent of RVT cells at the time of NSCLC resection will be reported.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.