Nebulized AER101 in Pre-op NSCLC
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Recurrent tumor(s)
Nodal or metastatic tumor (multiple lung tumors are acceptable)
Pregnant patients
Patients unable to provide informed consent
Trial design
Design model
Single group
Treatments tested in this trial
AER101
DrugNebulization of AER101
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Nebulized AER 101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PET SUVmax
decreased glycolysis
Time frame
14 daysSecondary outcomes
1
NSCLC System Assessment Questionnaire
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).
Time frame
Once daily during 14 day interventionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: