Nebulized AER101 in Pre-op NSCLC

University of Oklahoma (OU)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Non-small Cell Lung Cancer Stage II; Non-small Cell Lung Cancer Stage I

Treatments: Drug: AER101

Study type: Interventional

Funder types: Other

Identifiers

NCT07631299

19970P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Nebulized AER 101

Experimental group

Description:

Nebulized AER101, self-administered 3 times per day at 5 mL per treatment for 14 days

Treatment:

Drug: AER101