What this study is
The primary objective of this pilot study is to determine if AER101 can decrease glycolysis in non-small cell lung cancer (NSCLC). Glycolysis is the process cells use to break down sugar (glucose) into a smaller substance in the fluid part inside the cell. Many lung cancers begin in bronchi, bronchioles and alveoli cells surrounding the airways, which enables nebulization to deposit AER101 on lung tumors.
Participants in the study will self-administer AER101 via a hand-held personal nebulizer three times per day (dosing at least 4 hours apart) for 14 days prior to undergoing surgery for lung cancer.
What's being tested
- AER101
Intervention · DRUG
Nebulization of AER101
Study details
- Official title
- Nebulized AER101 to Inhibit Glycolysis for Pre-Operative Non-small Cell Lung Cancer (NSCLC)
- Sponsor
- University of Oklahoma
- Conditions
- Non-small Cell Lung Cancer Stage I · Non-small Cell Lung Cancer Stage II
- Enrolling
- 5 people
- Starts
- 2026-06
- Est. completion
- 2027-06
- Design
- Open-label, single group, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 18 years or older
- Agree to sign consent and follow study requirements
- Recently diagnosed with lung adenocarcinoma or squamous cell carcinoma
- Primary patients prior to resection
- Candidate for surgery (patients are qualified for inclusion if surgery or radiation treatment are agreed to)
- Baseline PET/CT imaging performed at Stephenson Cancer Center available and performed within previous 30 days
You can't join if
- Recurrent tumor(s)
- Nodal or metastatic tumor (multiple lung tumors are acceptable)
- Pregnant patients
- Patients unable to provide informed consent
- Prisoners
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openOU Medical Center Hospital
Oklahoma City, Oklahoma, United States
- Theresa J Lander · Contact4054015633theresa-lander@ou.edu
- James M Reinersman, MD · Principal investigator
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
- Theresa Lander · Contact4054015633theresa-lander@ou.edu
Study team
Sponsor
University of Oklahoma
Study ID 19970P
Principal investigator
Matthew Reinersman, MD
University of Oklahoma
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.