Recruiting
Phase 2

Esomeprazole

Sponsor:

Rush University Medical Center

Code:

NCT06120803

Conditions

Radiation Esophagitis

Locally Advanced Lung Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Esomeprazole 40 mg

Study Details

Brief summary:

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).

Conditions

Radiation Esophagitis

Locally Advanced Lung Carcinoma

Study ID

NCT06120803

Start date

Mar 1, 2024

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapy

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.

Interventions

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.

Primary outcome measure

  • Grade 2 or higher radiation induced esophagitis [ Time Frame: At 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy ]

Central Contacts and Locations

Central contacts

Soumyajit Roy, MD, MSc.(c)

312-942-5655soumyajit_roy@rush.edu

Gaurav Marwaha, MD

312-942-5751gaurav_marwaha@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Soumyajit Roy, MD

312-942-5655soumyajit_roy@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-08-14.