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Can a simple inhaler shield lung cancer patients from radiation side effects?

NCT ID NCT03803787

Disease control Sponsor: Instituto Nacional de Cancerologia de Mexico Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether taking inhaled budesonide (a steroid) twice daily during radiation therapy can reduce the severity of radiation pneumonitis—a common and serious lung inflammation—in people with non-small cell lung cancer. About 72 patients will be randomly assigned to receive the inhaler or not. The goal is to see if the steroid lowers the grade of pneumonitis and whether it affects the cancer treatment's success.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inhaled budesonide (a steroid)
What this could lead to
If it works, this could offer a simple way to prevent or lessen lung inflammation caused by radiation therapy in lung cancer patients.
What could go wrong
This is a small, early-phase trial with only 72 participants, so results may not apply broadly. The steroid may not reduce pneumonitis or could affect the cancer treatment's effectiveness.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with non-small cell lung cancer (NSCLC) with unresectable locally advanced or metastatic disease (IIIA, IIIB or IV) of the classification tumor node, metastasis (TNM) of malignant lung tumors, 7th edition. * NSCLC patients candidates for concomitant treatment (chemotherapy plus radiotherapy or target therapy plus radiotherapy). * Evidence of measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, Karnofsky 70-100. * Life expectancy of \> 4 months at the time of screening * Patients with the ability to comply with the study and follow-up procedures. * Patients with previous surgery less than four weeks. * Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures. Exclusion Criteria: * Unstable systemic disease: active infection, heart, liver, kidney or metabolic disease; including uncontrolled chronic lung disease. * Patients treated with systemic or inhaled corticosteroids. * Patients of reproductive age without a family planning method, pregnant or lactating. * Previous diagnosis of Pneumonitis with toxicity grade ≥ 2 by CTCAE v4.0 or RTOG scale. * Patients with disease progression. * Inspiratory flow \< 90 liters / min. * Discontinue of Treatment

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Conditions

The condition(s) this trial relates to.

lung disorder Lung Injury non-small cell lung carcinoma Radiation Fibrosis Syndrome respiratory tract neoplasm Thoracic Neoplasms radiation pneumonitis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Radiation pneumonitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Instituto Nacional de Cancerologia

    RECRUITING

    Mexico City, 14080, Mexico

    Contact Email: •••••@•••••

  • Instituto Nacional de Enfermedades Respiratorias

    ACTIVE_NOT_RECRUITING

    Mexico City, 14080, Mexico

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