Clinical trial · Interventional
Nebulized AER101 in Pre-op NSCLC
Nebulized AER101 to Inhibit Glycolysis for Pre-Operative Non-small Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Stage II | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AER101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nebulized AER 101
- description
- Nebulized AER101, self-administered 3 times per day at 5 mL per treatment for 14 days
- interventionNames
- Drug: AER101
Primary outcomes (1)
- measure
- PET SUVmax
- timeFrame
- 14 days
- description
- decreased glycolysis
Secondary outcomes (1)
- measure
- NSCLC System Assessment Questionnaire
- timeFrame
- Once daily during 14 day intervention
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTBushnell DM, Atkinson TM, McCarrier KP, Liepa AM, DeBusk KP, Coons SJ; Patient-Reported Outcome Consortium's NSCLC Working Group. Non-Small Cell Lung Cancer Symptom Assessment Questionnaire: Psychometric Performance and Regulatory Qualification of a Novel Patient-Reported Symptom Measure. Curr Ther Res Clin Exp. 2021 Aug 26;95:100642. doi: 10.1016/j.curtheres.2021.100642. eCollection 2021. PMID 34567289