Nebulized AER101 in Pre-op NSCLC

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.

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