lung cancer Non-Small cell lung carcinoma
Conditions
Interventions
Treatment may be delivered via either an endoluminal (bronchoscopic) or
percutaneous approach at the discretion of the clinical investigator utilizing
two available device configurations:
- Endolum
Sponsors
Galvanize Therapeutics Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Presence of solitary NSCLC nodule 8th ed. stage IA2, IA3 or IB • Nodule measuring > 1 cm and
Exclusion criteria
Exclusion criteria: • Additional pulmonary nodules requiring intervention • Patient is receiving concurrent cancer treatment (e.g. external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy) or has received treatment for the index tumor in the last two years • Patient has implanted lung devices or electronic devices • Patient has N1 disease • Patient is immune compromised or receiving immune modulating medication • Recurrent NSCLC within 2 years of initial definitive treatment • Previous checkpoint inhibitor treatment for another cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety analysis will be the rate of device and/or procedure related serious adverse events (SAEs) from the initial PEF treatment through surgical resection (approximately 30 days later). Clinical Utility will be assessed through the following measures. • Technical success defined as the frequency with which clinician can access the index tumor and deliver PEF energy • An assessment of the treatment zone from the resected specimen • Changes in post-treatment blood samples compared to pretreatment samples including: o Changes in phenotypes of lymphocytes analyzed by flow cytometry (e.g. CD3+, CD4+, CD8+, etc.) o Changes of serum levels of cytokines and mediators by ELISA assay or other method (e.g. IL-2, IL-6, IL-10, IL-12, etc.) • Characterization of the immunologic response in post-treatment tumor tissue samples compared to pre-treatment biopsy samples including: o Changes in histopathological assessment of immune response (PD-1/PD-L1 marker, tumor infiltrating lymphocytes, dendritic cell population, Treg population) o Pre and post treatment comparison of molecular NGS analysis of tumor samples o Histologic assessment of resected lymph nodes | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will also be assessed through gross and histologic assessment of the resected specimen including effects upon any adjacent bronchi and vasculature and through the collection of adverse events and serious adverse events. AEs and SAEs will be summarized using a standard medical coding dictionary (MedDRA). AEs and SAEs will be also be summarized based on Common Terminology for Adverse Events (CTCAE) version 5.0, relatedness to the device and/or procedure, and within discrete time periods in relation to the index procedure. Further, changes to planned surgical approach as consequence of the index procedure, 30-day surgical mortality, and percentage of surgical complications due to PEF treatment will also be collected and assessed. Additional exploratory endpoints include: • Post-PEF change in index tumor size (measured radiographically in 3 axial planes) compared to pre-PEF treatment CT • Pathologic response (PR) of the index tumor at surgical resection (measured as % of viable tumor remaining) • Assessment of pre-treatment and post PEF procedure (obtained just prior to resection) changes in bronchoalveolar lavage (BAL) samples • Outcomes as assessed through progression free survival (PFS) and overall survival (OS) at 12-months | — |
Countries
Netherlands
Outcome results
None listed