A Phase 2 interventional study of Esomeprazole 40 mg in Radiation Esophagitis and Locally Advanced Lung Carcinoma, sponsored by Rush University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Rush University Medical Center · Phase 2, Interventional, and Treatment
Thoracic radiation therapy combined with chemotherapy (with or without immunotherapy) is the cornerstone of management in patients with locally advanced non-small cell lung cancer (NSCLC).
Thoracic radiation therapy combined with chemotherapy (with or without immunotherapy) is the cornerstone of management in patients with locally advanced non-small cell lung cancer (NSCLC). Despite advancement in radiation delivery techniques, about 1/3 of patients who undergo thoracic radiation therapy (TRT) for advanced NSCLC suffer from symptoms of radiation-induced inflammation of the esophagus, also known as radiation-induced esophagitis (RE). Radiation induced esophagitis can have detrimental effect on quality-of-life and can result in unplanned treatment interruptions. If not treated appropriately, acute severe radiation induced esophagitis might also progress to long-term consequences such as esophageal stricture. Existing management of radiation induced esophagitis entails addressing the symptoms and nutritional needs. Anecdotal reports have shown improvement in radiation induced esophagitis symptoms with proton pump inhibitors (PPI); however, no robust prospective evidence exists to support use of PPI to manage radiation induced esophagitis to mitigate detrimental impact on QoL. Recent studies have shown that the PPI esomeprazole has antioxidant, anti-inflammatory and antifibrotic properties; and it potentiates the effect of ionizing radiation on cancer cells.
The investigators hypothesize that the use of esomeprazole will reduce the frequency of symptomatic (grade ≥2) radiation induced esophagitis compared to reported rates in literature. To address this hypothesis, the investigators propose a phase II study with locally advanced non-small cell lung cancer (NSCLC) patients with the following objectives: The primary objective is to evaluate the frequency of acute symptomatic RE and associated patient-reported symptoms with use of 40 mg of esomeprazole (two pills of 20 mg strength of esomeprazole) once daily for the duration of TRT and for two weeks after completion of TRT. Finally, as exploratory objectives, the investigators plan to identify orthogonal biomarkers that predict radiation induced esophagitis (RE) in the context of using esomeprazole.
The frequency of symptomatic radiation induced esophagitis at 2 weeks after RT completion and at 3 months from the start of TRT will be documented in a cohort of patients with locally advanced NSCLC receiving TRT (EQD2 of 45 Gy or higher with concomitant chemotherapy and estimated esophageal maximum dose of 30 Gy or higher). Both clinician-reported metrics (Common Terminology Criteria for Adverse Events version 5.0) and patient-reported metrics (Patient-Reported Outcomes version of the CTCAE [PRO-CTCAE]) will be used.
As part of exploratory objectives, investigators will investigate correlative biomarkers that could predict radiation-induced esophagitis in the context of using esomeprazole.
This work is significant as it will provide important evidence to support the use of esomeprazole, a readily available over-the-counter medication with thoracic radiation therapy to reduce the frequency of symptomatic radiation induced esophagitis given the lack of clinical evidence in the existing literature supporting this premise.
123 studies on the registry are indexed under Esophagitis; 15 are open to participants now.
This study's planned enrollment of 48 is below the median of 96 across 99 interventional studies indexed under Esophagitis.
Browse Esophagitis studies →Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Enrolled patients will receive 40 mg of esomeprazole (two pills of 20 mg strength of esomeprazole) once daily before breakfast for the entire duration of TRT (including the weekends and any interim gap period) and for two weeks after completion of thoracic radiation therapy (TRT). TRT will be delivered as per the discretion of the treating physicians.
Drug: Esomeprazole 40 mg
Enrolled patients will receive 40 mg of esomeprazole (two pills of 20 mg strength of esomeprazole) once daily before breakfast for the entire duration of TRT (including the weekends and any interim gap period) and for two weeks after completion of thoracic radiation therapy.
Grade 2 or higher radiation induced esophagitis
The primary objective of this study is to determine the effect of esomeprazole on the frequency of acute symptomatic RE after thoracic radiotherapy (TRT) in a cohort of patients with locally advanced NSCLC treated with definitive TRT. Both clinician-reported metrics (CTCAE) and patient-reported metrics (Patient-Reported Outcomes version of the CTCAE) will be used.
Time frame: At 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy
Plan to share: Undecided — Information on IPD sharing will be determined at the study completion
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Dec 2027, 45 months after the start.
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Studies of the drug tested here: Esomeprazole
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