Non-small Cell Lung Cancer Stage IEarly Phase 1AER101NCT07631299
Nebulized AER101 in Pre-op NSCLC
A Early Phase 1 study testing AER101 in people with Non-small Cell Lung Cancer Stage I and Non-small Cell Lung Cancer Stage II, run by University of Oklahoma at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II
- What is being tested?
- AER101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2026to Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Recurrent tumor(s)
- Nodal or metastatic tumor (multiple lung tumors are acceptable)
- Pregnant patients
- Patients unable to provide informed consent
- Prisoners
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
OU Medical Center Hospital
Oklahoma City, Oklahoma, 73106
Theresa J Lander, 4054015633, theresa-lander@ou.edu
James M Reinersman, MD
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73106
Theresa Lander, 4054015633, theresa-lander@ou.edu
About this study
Official title: Nebulized AER101 to Inhibit Glycolysis for Pre-Operative Non-small Cell Lung Cancer (NSCLC)
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.
Read the detailed description
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.
- Being tested
- AER101
- Keywords
- Non-small Cell Lung Cancer, Nebulization
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AER101Drug
Nebulization of AER101
| Study group | Role | What they receive |
|---|---|---|
| Nebulized AER 101 | Experimental | Nebulized AER101, self-administered 3 times per day at 5 mL per treatment for 14 days Receives: Drug: AER101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET SUVmax
decreased glycolysis
Measured: 14 days
Secondary 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).
Measured: Once daily during 14 day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer Stage IStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof-of-concept, single treatment group, participants blinded to formulation.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Reinersman, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631299
- Sponsor's protocol ID
- 19970P
- Acronym
- AER101
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34567289
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized AER101 to Inhibit Glycolysis for Pre-Operative Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT07631299
- Acronym / sponsor ID
- AER101 / 19970P
- Keywords
- Non-small Cell Lung Cancer, Nebulization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof-of-concept, single treatment group, participants blinded to formulation.
| Arm | Type | Receives |
|---|---|---|
| Nebulized AER 101 | Experimental | Drug: AER101Nebulized AER101, self-administered 3 times per day at 5 mL per treatment for 14 days |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- Recurrent tumor(s)
- Nodal or metastatic tumor (multiple lung tumors are acceptable)
- Pregnant patients
- Patients unable to provide informed consent
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AER101Nebulization of AER101 | Drug | Nebulized AER 101 |
Primary outcome
PET SUVmax
Time frame: 14 days
decreased glycolysis
1 secondary outcome
NSCLC System Assessment Questionnaire
Time frame: Once daily during 14 day intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Results publication: PubMed 34567289Bushnell 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.
- FDA instructions for when an IND is requiredLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer Stage I
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
RecruitingPhase 1
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Ovarian Neoplasms, Endometrial Neoplasms
Not yet recruitingObservational study
Treatment Pattern and Patient Outcomes Among Stage I-II Unresected NSCLC Patients
Non-small Cell Lung Cancer, NSCLC
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Reinersman, MD principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AER101 in people with Non-small Cell Lung Cancer Stage I and Non-small Cell Lung Cancer Stage II, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theresa J Lander (405-271-8001 ext. 39509, theresa-lander@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET SUVmax (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07631299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.