Not yet recruitingEarly Phase 1

Nebulized AER101 in Pre-op NSCLC

Nebulized AER101 to Inhibit Glycolysis for Pre-Operative Non-small Cell Lung Cancer (NSCLC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 14 days
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Each patient will receive a nebulizer and will self-administer the study drug 3 times a day for 14 days."
  • "Patients will also complete a daily assessment survey at each treatment time."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (2)

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