Could a common heartburn drug shield lung cancer patients from radiation side effects?
NCT ID NCT06120803
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This phase II trial tests whether esomeprazole, a common acid-reducing drug, can lower the chance of severe esophagitis (inflammation of the food pipe) in people with stage III non-small cell lung cancer receiving radiation therapy. Participants take 40 mg of esomeprazole daily during radiation and for two weeks after. The study measures how many patients develop grade 2 or higher esophagitis, using both doctor and patient reports.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- esomeprazole 40 mg once daily during and after thoracic radiation therapy
- What this could lead to
- If effective, esomeprazole could become a simple, low-cost way to prevent painful swallowing and chest discomfort during radiation for lung cancer, improving quality of life.
- What could go wrong
- This is a small, single-arm phase II trial, so results may not be definitive. Esomeprazole may not reduce esophagitis, and it carries rare risks like headache, diarrhea, or long-term effects with extended use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient is ≥ 18 years of age. * Patient or patient's legal representative is willing and able to provide written informed consent and HIPAA authorization prior to performance of any study related activity. * Patient is willing and able to comply with scheduled visits and treatment schedules. * Patient has histopathologically confirmed diagnosis of NSCLC clinical stage III (as per the 8th edition of American Joint Committee on Cancer Staging). * Patients will receive thoracic radiation with estimated maximum dose to esophagus of at least 30 Gy (EQD2) in combination with concomitant chemotherapy. * Patient has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. * Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine HCG) within 2 weeks of enrollment). * Double inclusion in any ongoing trial (if the other trial permits) will be allowed. Exclusion Criteria: * Patient has history of gastroesophageal junction or stomach cancer. * Patient has history of pre-existing severe or very severe dysphagia. * Patient has history of severe liver disease, acute or subacute systemic lupus erythematosus. * Patient has interstitial nephritis. * Patient has history of peptic ulcer disease. * Patient has prior history of upper gastrointestinal bleeding. * Patient has a history of thoracic radiotherapy within 2 years of enrollment. * Patient has known or suspected allergic response and prior adverse drug reaction with proton pump inhibitors. * Patient is currently on clopidogrel, nelfinavir, rilpivirine, methotrexate, rifampin, digoxin, tacrolimus, or phenytoin as these may have major drug interaction with esomeprazole. * Patients without concomitant chemoradiotherapy and with estimated maximum dose to esophagus of less than 30 Gy (EQD2).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rush University Medical Center
RECRUITINGChicago, Illinois, 60612, United States
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