Nebulized AER101 in Pre-op NSCLC

NCT07631299 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 19970P
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

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

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

Keywords

Non-small Cell Lung Cancer; Nebulization

Outcome Measures

Primary Outcomes (1)

• PET SUVmax

  decreased glycolysis

  14 days

Secondary Outcomes (1)

• NSCLC System Assessment Questionnaire

  Once daily during 14 day intervention

Study Arms (1)

Nebulized AER 101

EXPERIMENTAL

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

Drug: AER101

Interventions

AER101 DRUG

Nebulization of AER101

Nebulized AER 101

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Baseline PET/CT imaging performed at Stephenson Cancer Center available and performed within previous 30 days

You may not qualify if:

• Recurrent tumor(s)
• Nodal or metastatic tumor (multiple lung tumors are acceptable)
• Pregnant patients
• Patients unable to provide informed consent
• Prisoners

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (2)

OU Medical Center Hospital

Oklahoma City, Oklahoma, 73106, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73106, United States

Location

Related Publications (1)

• Bushnell 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 RESULT

Related Links

• FDA instructions for when an IND is required

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Matthew Reinersman, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa J Lander

CONTACT

405-271-8001; theresa-lander@ou.edu

Matthew R Reinersman, MD

CONTACT

405-271-4505; matthew-reinersman@ou.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Patients are blinded to the specific formulation of AER101.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof-of-concept, single treatment group, participants blinded to formulation.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)