Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II
Conditions
Keywords
Non-small Cell Lung Cancer, Nebulization
Brief summary
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.
Detailed description
This is a pilot study that will enroll 5 patients with Stage I or Stage II NSCLC. Each patient will receive a nebulizer and will self-administer the study drug 3 times a day for 14 days. The research team will perform a PET CT scan at the beginning of the study (no more than 30 days prior to study) and again at the last treatment. The final treatment will be done at the clinic so that the PET/CT can be performed within about one hour. Patient surgery will already be scheduled to occur shortly after the treatment has been completed. Patients will also complete a daily assessment survey at each treatment time. There is only one treatment arm and no control group. The study is of minimal risk and the investigator expects enrollment to be completed in approximately 6 months.
Interventions
DRUGAER101
Nebulization of AER101
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients are blinded to the specific formulation of AER101.
Intervention model description
Proof-of-concept, single treatment group, participants blinded to formulation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Recurrent tumor(s) * Nodal or metastatic tumor (multiple lung tumors are acceptable) * Pregnant patients * Patients unable to provide informed consent * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET SUVmax | 14 days | decreased glycolysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NSCLC System Assessment Questionnaire | Once daily during 14 day intervention | Patients are asked to rate coughing episodes, chest pain, shortness of breath, fatigue, and appetite. The PRO Consortium's 9 NSCLC Working Group developed the NSCLC-SAQ with consideration of the recommendations and scientific best practices set forth in the FDA guidance. The NSCLC patient symptoms are each rated from 1 (Never/no pain/No Coughing) to 5 (Always/Very Severe). |
Countries
United States
Contacts
CONTACTTheresa J Lander
CONTACTMatthew R Reinersman, MD
PRINCIPAL_INVESTIGATORMatthew Reinersman, MD
University of Oklahoma
Outcome results
None listed