Radiation PneumonitisPhase 2NCT03803787

Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients

A Phase 2 study testing Inhaled budesonide in people with Radiation Pneumonitis, run by Instituto Nacional de Cancerologia de Mexico at 2 sites in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This randomized clinical study aims to assess whether prophylactic treatment with inhaled steroids in patients with locally advanced or concomitantly treated non-small cell lung carcinoma who are candidates for combination treatment with QT/RT or IMT + QT/RT. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Radiation Pneumonitis
What is being tested?: Inhaled budesonide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 2 sitesMexico
Study dates: 1 Sep 2018to 1 Dec 2027
Phase: Phase 2
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Oscar Arrieta, MD MSc contact

015556280400 ext. 71100

ogarrieta@gmail.com

Diana Flores contact

015556280400 ext. 71101

clinicacancerpulmonincan@gmail.com

Mexico2 sites, 1 recruiting

Instituto Nacional de Cancerologia
Mexico City, 14080
Oscar Arrieta, MD MSc, 015556280400 ext. 71100, ogarrieta@gmail.com
Diana Flores, 015556280400 ext. 71101, clinicacancerpulmonincan@gmail.com
Recruiting
Instituto Nacional de Enfermedades Respiratorias
Mexico City, 14080
Active, not recruiting

Other trials in Mexico

About this study

Official title: Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Non-small Cell Lung Cancer Patients

The main questions it aims to answer are:

Whether prophylactic treatment decreases the severity of NPR on CTCAE v4.0 and RTOG scales.

Whether inhaled steroid use modifies the response to radiation therapy treatment compared to patients who do not receive prophylactic inhaled steroids.

Read the detailed description

Clinical evaluation

The following BASELINE data shall be taken prior to radiation therapy:

Demographic, clinical, laboratory, and imaging data will be obtained from medical history and electronic records.

The patient will be instructed to perform the PFRs and tests of lung function.

Two EORTC, QLQ-C30, and QLQ LC13 quality of life questionnaires and three respiratory symptom questionnaires (St. George, dyspnea scale, and modified BORG) will be performed on the same day of lung function tests.

Additionally; blood samples will be taken for the evaluation of inflammatory mediators at the following times: BASAL (before RT), and every six weeks up to 48 weeks post-RT.

INTERVENTION GROUP

Prior to the onset of RT, the patient will be sorted to receive the control rather than experimental intervention (QT/RT or IMT + QT/RT) and a logbook to record adherence to treatment.
An IDM device shall be granted per month, containing the number of doses corresponding to 30 days. The record in the database of the day of the first session of RT will be taken to quantify the number of days of use of the drug and grant the next device per 30 days until the end of the study.
The patient will be instructed on the use of the device inhaled with the spacer chamber in the clinic Pulmonology consultation, alarm data and indications of the use of the drug will be given in writing, and knowledge will be reinforced at each visit.
The patient will be granted the drug use log where the patient will place the date and time of use of the drug to assess adherence to treatment

Conditions: Radiation Pneumonitis
Being tested: Inhaled budesonide
Keywords: Non-Small Cell Lung Cancer, Radiation Pneumonia, Lung cancer treatment, Respiratory Tract Neoplasms, Radiation fibrosis, Thoracic Neoplasms, Lung Diseases, Radiation Injury with Fibrosis, Radiation Fibrosis of Lung, Lung Injury
Medical subject headings: Radiation Pneumonitis, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Radiation Fibrosis Syndrome, Thoracic Neoplasms, Lung Diseases, Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inhaled budesonideDrug
Also called Numark
Patients will use inhaled budesonide (Numark) with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.

Study groups in NCT03803787
Study group	Role	What they receive
QT/RT + Budesonide	Experimental	Patients are receiving chemotherapy (QT) and radiotherapy (RT) plus inhaled Budesonide with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed. Receives: Drug: Inhaled budesonide
QT/RT + No medication	No intervention	Patients are receiving chemotherapy (QT) and radiotherapy (RT) without intervention therapy and followed during 12 months.
Target drug/RT + Budesonide	Experimental	Patients are receiving target therapy and radiotherapy (RT) plus inhaled Budesonide with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed. Receives: Drug: Inhaled budesonide
Target drug/RT + No medication	No intervention	Patients are receiving target treatment and radiotherapy (RT) without intervention therapy and followed during 12 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pneumonitis graded by the Common terminology criteria for adverse event v4.0. (CTCAE v4.0).
Current score for radiation pneumonitis according to symptoms and radiographic changes. Grade 0: No changes, Grade 1: Asymptomatic or mild respiratory symptoms, Grade 2: Moderate respiratory symptoms of pneumonitis (a severe cough) and radiographic changes (radiographic patches), Grade 3: Severe respiratory symptoms of pneumonitis, dense radiographic changes. Grade 4: Symptoms of acute respiratory failure requiring assisted ventilation or continuous oxygen. Grade 5: Death directly related to late effects of radiotherapy.
Measured: from the beginning of radiotherapy up to 1 year after the 1st session.
Pneumonitis graded by the Radiation Therapy Oncology Group score (RTOG)
Current score for radiation pneumonitis according to symptoms and radiographic changes. Grade 0: No changes, Grade 1: Asymptomatic, only radiological or tomographic findings, Grade 2: Symptomatic, does not interfere with daily activities, Grade 3: Symptomatic, interferes with daily activities, requires supplemental oxygen. Grade 4: Threatens life, needing ventilator support. Grade 5: Severe pneumonitis with fatal outcome.
Measured: from the beginning of radiotherapy up to 1 year after the 1st session.

Secondary outcomes (13)

Lung cancer-associated symptoms assessment
Symptoms are evaluated with the supplementary lung cancer-specific questionnaire of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (validated Mexican-Spanish version).
It comprises 13 questions related to the assessment of dyspnoea, pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that scores range from 0 to 100. A higher scale score represents a higher level of symptoms.
Measured: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Treatment-related side effects in lung cancer
Symptoms are evaluated with the supplementary lung cancer-specific questionnaire of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (validated Mexican-Spanish version).
It comprises 13 questions related to the assessment of dyspnoea, pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that scores range from 0 to 100. A higher scale score represents a higher level of side-effects.
Measured: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Cognitive functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
The cognitive functioning is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires.
It comprises two questions related to the assessment of short and long-term memory. The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that scores range from 0 to 100. A higher scale score represents a healthy level of functioning.
Measured: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Emotional Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
The Emotional Functioning is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires.
It comprises four questions related to the assessment of depression, anxiety, irritability, and stress. The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that the scores range from 0 to 100. A higher scale score represents a represents a healthy level of functioning.
Measured: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment
Physical functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
The Physical functioning is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires.
It comprises five questions related to self-sufficiency activities (eating, walking, laying in bed or completing simple chores). The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that the scores range from 0 to 100. A higher scale score represents a represents a healthy level of functioning.
Measured: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Role Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
The Role functioning is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires.
It comprises two questions related to daily activities (work and hobbies limitation). The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that the scores range from 0 to 100. A higher scale score represents a represents a healthy level of functioning.
Measured: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Social Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
The Social Functioning is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires.
It comprises two questions related to family life and social activities. The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that the scores range from 0 to 100. A higher scale score represents a represents a healthy level of functioning.
Measured: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Respiratory symptoms evaluation using St. George respiratory questionnaire
Respiratory symptoms are evaluated using the St. George respiratory questionnaire validated to Mexican-Spanish version. It is a disease-specific instrument designed to measure the impact on overall health, daily life, and perceived well-being in patients with airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Dyspnea assessment by the Borg Scale Dyspnea Index (BSDI)
A system used to document the severity of the patient's shortness of breath using numbers anchored with verbal descriptions. This scale asks the patient to rate the dyspnea. It starts at number 0 where the breathing is causing no difficulty at all and progresses through to number 10 where the breathing difficulty is maximal.
Measured: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Pulmonary function evaluation using spirometry test
Spirometry measures the inhaled and exhaled air volume as a function of time using a forced expiratory maneuver.
Measured: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment
Pulmonary function evaluation using diffusion lung capacity of carbon monoxide measurement (DLCO).
Diffusion lung capacity of carbon monoxide (DLCO) test measures the conductance of gas transfer from inspired gas to the red blood cells.
Measured: before the start of Radiotherapy and at 6, 12, 24 and 48-weeks post-treatment.
Airway inflammatory response evaluation using the fraction of exhaled nitric oxide measurement (FeNO)
Nitric oxide concentration detected in the exhaled gas by chemiluminescence reported as particles per million.
Measured: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Pulmonary function evaluation using Impulse oscillometry test (IOS)
Impulse oscillometry provides a rapid, noninvasive measure of airway impedance during normal tidal breathing.
Measured: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20181 Dec 2027

First posted15 Jan 2019
Study start1 Sep 2018
Primary completion1 Dec 2026 (estimated)
Study completion1 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Radiation PneumonitisStudies of the same condition, open and under way.
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: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03803787
Sponsor's protocol ID: CI/910/17
Status last verified: Apr 2026
First submitted: 3 Jan 2019
Last updated: 8 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data of the participants will be reported in the publication results.

Publications

Arrieta O, Guzman-de Alba E, Alba-Lopez LF, Acosta-Espinoza A, Alatorre-Alexander J, Alexander-Meza JF, Allende-Perez SR, Alvarado-Aguilar S, Araujo-Navarrete ME, Argote-Greene LM, Aquino-Mendoza CA, Astorga-Ramos AM, Austudillo-de la Vega H, Aviles-Salas A, Barajas-Figueroa LJ, Barroso-Quiroga N, Blake-Cerda M, Cabrera-Galeana PA, Calderillo-Ruiz G, Campos-Parra AD, Cano-Valdez AM, Capdeville-Garcia D, Castillo-Ortega G, Casillas-Suarez C, Castillo-Gonzalez P, Corona-Cruz JF, Correa-Acevedo ME, Cortez-Ramirez SS, de la Cruz-Vargas JA, de la Garza-Salazar JG, de la Mata-Moya MD, Dominguez-Flores ME, Dominguez-Malagon HR, Dominguez-Parra LM, Dominguez-Peregrina A, Duran-Alcocer J, Enriquez-Aceves MI, Elizondo-Rios A, Escobedo-Sanchez MD, de Villafranca PE, Flores-Cantisani A, Flores-Gutierrez JP, Franco-Marina F, Franco-Gonzalez EE, Franco-Topete RA, Fuentes-de la Pena H, Galicia-Amor S, Gallardo-Rincon D, Gamboa-Dominguez A, Garcia-Andreu J, Garcia-Cuellar CM, Garcia-Sancho-Figueroa MC, Garcia-Torrentera R, Gerson-Cwilich R, Gomez-Gonzalez A, Green-Schneeweiss L, Guillen-Nunez Mdel R, Gutierrez-Velazquez H, Ibarra-Perez C, Jimenez-Fuentes E, Juarez-Sanchez P, Juarez-Ramiro A, Kelly-Garcia J, Kuri-Exsome R, Lazaro-Leon JM, Leon-Rodriguez E, Llanos-Osuna S, Llanos-Osuna S, Loyola-Garcia U, Lopez-Gonzalez JS, Lopez y de Antunano FJ, Loustaunau-Andrade MA, Macedo-Perez EO, Machado-Villarroel L, Magallanes-Maciel M, Martinez-Barrera L, Martinez-Cedillo J, Martinez-Martinez G, Medina-Esparza A, Meneses-Garcia A, Mohar-Betancourt A, Morales Blanhir J, Morales-Gomez J, Motola-Kuba D, Najera-Cruz MP, Nunez-Valencia Cdel C, Ocampo-Ocampo MA, Ochoa-Vazquez MD, Olivares-Torres CA, Palomar-Lever A, Patino-Zarco M, Perez-Padilla R, Pena-Alonso YR, Perez-Romo AR, Aquilino Perez M, Pinaya-Ruiz PM, Pointevin-Chacon MA, Poot-Braga JJ, Posadas-Valay R, Ramirez-Marquez M, Reyes-Martinez I, Robledo-Pascual J, Rodriguez-Cid J, Rojas-Marin CE, Romero-Bielma E, Rubio-Gutierrez JE, Saenz-Frias JA, Salazar-Lezama MA, Sanchez-Lara K, Sansores Martinez R, Santillan-Doherty P, Alejandro-Silva J, Tellez-Becerra JL, Toledo-Buenrostro V, Torre-Bouscoulet L, Torecillas-Torres L, Torres M, Tovar-Guzman V, Turcott-Chaparro JG, Vazquez-Cortes JJ, Vazquez-Manriquez ME, Vilches-Cisneros N, Villegas-Elizondo JF, Zamboni MM, Zamora-Moreno J, Zinser-Sierra JW. [National consensus of diagnosis and treatment of non-small cell lung cancer]. Rev Invest Clin. 2013 Mar;65 Suppl 1:S5-84. Spanish.
PubMed 24459776
Timmerman R, McGarry R, Yiannoutsos C, Papiez L, Tudor K, DeLuca J, Ewing M, Abdulrahman R, DesRosiers C, Williams M, Fletcher J. Excessive toxicity when treating central tumors in a phase II study of stereotactic body radiation therapy for medically inoperable early-stage lung cancer. J Clin Oncol. 2006 Oct 20;24(30):4833-9. doi: 10.1200/JCO.2006.07.5937.
PubMed 17050868
Henkenberens C, Janssen S, Lavae-Mokhtari M, Leni K, Meyer A, Christiansen H, Bremer M, Dickgreber N. Inhalative steroids as an individual treatment in symptomatic lung cancer patients with radiation pneumonitis grade II after radiotherapy - a single-centre experience. Radiat Oncol. 2016 Feb 2;11:12. doi: 10.1186/s13014-016-0580-3.
PubMed 26830686
Kim S, Oh IJ, Park SY, Song JH, Seon HJ, Kim YH, Yoon SH, Yu JY, Lee BR, Kim KS, Kim YC. Corticosteroid therapy against treatment-related pulmonary toxicities in patients with lung cancer. J Thorac Dis. 2014 Sep;6(9):1209-17. doi: 10.3978/j.issn.2072-1439.2014.07.16.
PubMed 25276362
Ding NH, Li JJ, Sun LQ. Molecular mechanisms and treatment of radiation-induced lung fibrosis. Curr Drug Targets. 2013 Oct;14(11):1347-56. doi: 10.2174/13894501113149990198.
PubMed 23909719
Williams JP, Johnston CJ, Finkelstein JN. Treatment for radiation-induced pulmonary late effects: spoiled for choice or looking in the wrong direction? Curr Drug Targets. 2010 Nov;11(11):1386-94. doi: 10.2174/1389450111009011386.
PubMed 20583979
Daley-Yates PT. Inhaled corticosteroids: potency, dose equivalence and therapeutic index. Br J Clin Pharmacol. 2015 Sep;80(3):372-80. doi: 10.1111/bcp.12637. Epub 2015 May 28.
PubMed 25808113
Leach C, Colice GL, Luskin A. Particle size of inhaled corticosteroids: does it matter? J Allergy Clin Immunol. 2009 Dec;124(6 Suppl):S88-93. doi: 10.1016/j.jaci.2009.09.050.
PubMed 19962042
Bledsoe TJ, Nath SK, Decker RH. Radiation Pneumonitis. Clin Chest Med. 2017 Jun;38(2):201-208. doi: 10.1016/j.ccm.2016.12.004. Epub 2017 Mar 1.
PubMed 28477633
Simone CB 2nd. Thoracic Radiation Normal Tissue Injury. Semin Radiat Oncol. 2017 Oct;27(4):370-377. doi: 10.1016/j.semradonc.2017.04.009.
PubMed 28865520
Vallard A, Rancoule C, Le Floch H, Guy JB, Espenel S, Le Pechoux C, Deutsch E, Magne N, Chargari C. [Medical prevention and treatment of radiation-induced pulmonary complications]. Cancer Radiother. 2017 Aug;21(5):411-423. doi: 10.1016/j.canrad.2017.03.004. Epub 2017 Jun 5. French.
PubMed 28596060

Interested in taking part?

Oscar Arrieta, MD MSc

015556280400 ext. 71100

ogarrieta@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Non-Small Cell Lung Cancer, Radiation Induced Lung Injury (RILI)

All Radiation Pneumonitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Non-small Cell Lung Cancer Patients
ClinicalTrials.gov ID: NCT03803787
Acronym / sponsor ID: CI/910/17
Conditions: Radiation Pneumonitis
Keywords: Non-Small Cell Lung Cancer, Radiation Pneumonia, Lung cancer treatment, Respiratory Tract Neoplasms, Radiation fibrosis, Thoracic Neoplasms, Lung Diseases, Radiation Injury with Fibrosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 72 participants (estimated)
Lead sponsor: Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
Collaborators: Instituto Nacional de Enfermedades Respiratorias
Study start: 1 Sep 2018 (actual)
Primary completion: 1 Dec 2026 (estimated)
Study completion: 1 Dec 2027 (estimated)
First posted: 15 Jan 2019 (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 main questions it aims to answer are:

Whether prophylactic treatment decreases the severity of NPR on CTCAE v4.0 and RTOG scales.

Whether inhaled steroid use modifies the response to radiation therapy treatment compared to patients who do not receive prophylactic inhaled steroids.

Detailed description

Clinical evaluation

The following BASELINE data shall be taken prior to radiation therapy:

Demographic, clinical, laboratory, and imaging data will be obtained from medical history and electronic records.

The patient will be instructed to perform the PFRs and tests of lung function.

Additionally; blood samples will be taken for the evaluation of inflammatory mediators at the following times: BASAL (before RT), and every six weeks up to 48 weeks post-RT.

INTERVENTION GROUP

Prior to the onset of RT, the patient will be sorted to receive the control rather than experimental intervention (QT/RT or IMT + QT/RT) and a logbook to record adherence to treatment.
An IDM device shall be granted per month, containing the number of doses corresponding to 30 days. The record in the database of the day of the first session of RT will be taken to quantify the number of days of use of the drug and grant the next device per 30 days until the end of the study.
The patient will be instructed on the use of the device inhaled with the spacer chamber in the clinic Pulmonology consultation, alarm data and indications of the use of the drug will be given in writing, and knowledge will be reinforced at each visit.
The patient will be granted the drug use log where the patient will place the date and time of use of the drug to assess adherence to treatment

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
QT/RT + Budesonide	Experimental	Drug: Inhaled budesonidePatients are receiving chemotherapy (QT) and radiotherapy (RT) plus inhaled Budesonide with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.
QT/RT + No medication	No intervention	–Patients are receiving chemotherapy (QT) and radiotherapy (RT) without intervention therapy and followed during 12 months.
Target drug/RT + Budesonide	Experimental	Drug: Inhaled budesonidePatients are receiving target therapy and radiotherapy (RT) plus inhaled Budesonide with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.
Target drug/RT + No medication	No intervention	–Patients are receiving target treatment and radiotherapy (RT) without intervention therapy and followed during 12 months.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (7 listed)

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.

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
Inhaled budesonideAlso: NumarkPatients will use inhaled budesonide (Numark) with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.	Drug	QT/RT + Budesonide, Target drug/RT + Budesonide

Primary outcome

Pneumonitis graded by the Common terminology criteria for adverse event v4.0. (CTCAE v4.0).
Time frame: from the beginning of radiotherapy up to 1 year after the 1st session.
Current score for radiation pneumonitis according to symptoms and radiographic changes. Grade 0: No changes, Grade 1: Asymptomatic or mild respiratory symptoms, Grade 2: Moderate respiratory symptoms of pneumonitis (a severe cough) and radiographic changes (radiographic patches), Grade 3: Severe respiratory symptoms of pneumonitis, dense radiographic changes. Grade 4: Symptoms of acute respiratory failure requiring assisted ventilation or continuous oxygen. Grade 5: Death directly related to late effects of radiotherapy.
Pneumonitis graded by the Radiation Therapy Oncology Group score (RTOG)
Time frame: from the beginning of radiotherapy up to 1 year after the 1st session.
Current score for radiation pneumonitis according to symptoms and radiographic changes. Grade 0: No changes, Grade 1: Asymptomatic, only radiological or tomographic findings, Grade 2: Symptomatic, does not interfere with daily activities, Grade 3: Symptomatic, interferes with daily activities, requires supplemental oxygen. Grade 4: Threatens life, needing ventilator support. Grade 5: Severe pneumonitis with fatal outcome.

13 secondary outcomes

Lung cancer-associated symptoms assessment
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Treatment-related side effects in lung cancer
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Cognitive functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Emotional Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment
Physical functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Role Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Social Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Respiratory symptoms evaluation using St. George respiratory questionnaire
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Dyspnea assessment by the Borg Scale Dyspnea Index (BSDI)
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Pulmonary function evaluation using spirometry test
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment
Pulmonary function evaluation using diffusion lung capacity of carbon monoxide measurement (DLCO).
Time frame: before the start of Radiotherapy and at 6, 12, 24 and 48-weeks post-treatment.
Airway inflammatory response evaluation using the fraction of exhaled nitric oxide measurement (FeNO)
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Pulmonary function evaluation using Impulse oscillometry test (IOS)
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.

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 Apr 2026.
Results publication: PubMed 24459776Arrieta O, Guzman-de Alba E, Alba-Lopez LF, Acosta-Espinoza A, Alatorre-Alexander J, Alexander-Meza JF, Allende-Perez SR, Alvarado-Aguilar S, Araujo-Navarrete ME, Argote-Greene LM, Aquino-Mendoza CA, Astorga-Ramos AM, Austudillo-de la Vega H, Aviles-Salas A, Barajas-Figueroa LJ, Barroso-Quiroga N, Blake-Cerda M, Cabrera-Galeana PA, Calderillo-Ruiz G, Campos-Parra AD, Cano-Valdez AM, Capdeville-Garcia D, Castillo-Ortega G, Casillas-Suarez C, Castillo-Gonzalez P, Corona-Cruz JF, Correa-Acevedo ME, Cortez-Ramirez SS, de la Cruz-Vargas JA, de la Garza-Salazar JG, de la Mata-Moya MD, Dominguez-Flores ME, Dominguez-Malagon HR, Dominguez-Parra LM, Dominguez-Peregrina A, Duran-Alcocer J, Enriquez-Aceves MI, Elizondo-Rios A, Escobedo-Sanchez MD, de Villafranca PE, Flores-Cantisani A, Flores-Gutierrez JP, Franco-Marina F, Franco-Gonzalez EE, Franco-Topete RA, Fuentes-de la Pena H, Galicia-Amor S, Gallardo-Rincon D, Gamboa-Dominguez A, Garcia-Andreu J, Garcia-Cuellar CM, Garcia-Sancho-Figueroa MC, Garcia-Torrentera R, Gerson-Cwilich R, Gomez-Gonzalez A, Green-Schneeweiss L, Guillen-Nunez Mdel R, Gutierrez-Velazquez H, Ibarra-Perez C, Jimenez-Fuentes E, Juarez-Sanchez P, Juarez-Ramiro A, Kelly-Garcia J, Kuri-Exsome R, Lazaro-Leon JM, Leon-Rodriguez E, Llanos-Osuna S, Llanos-Osuna S, Loyola-Garcia U, Lopez-Gonzalez JS, Lopez y de Antunano FJ, Loustaunau-Andrade MA, Macedo-Perez EO, Machado-Villarroel L, Magallanes-Maciel M, Martinez-Barrera L, Martinez-Cedillo J, Martinez-Martinez G, Medina-Esparza A, Meneses-Garcia A, Mohar-Betancourt A, Morales Blanhir J, Morales-Gomez J, Motola-Kuba D, Najera-Cruz MP, Nunez-Valencia Cdel C, Ocampo-Ocampo MA, Ochoa-Vazquez MD, Olivares-Torres CA, Palomar-Lever A, Patino-Zarco M, Perez-Padilla R, Pena-Alonso YR, Perez-Romo AR, Aquilino Perez M, Pinaya-Ruiz PM, Pointevin-Chacon MA, Poot-Braga JJ, Posadas-Valay R, Ramirez-Marquez M, Reyes-Martinez I, Robledo-Pascual J, Rodriguez-Cid J, Rojas-Marin CE, Romero-Bielma E, Rubio-Gutierrez JE, Saenz-Frias JA, Salazar-Lezama MA, Sanchez-Lara K, Sansores Martinez R, Santillan-Doherty P, Alejandro-Silva J, Tellez-Becerra JL, Toledo-Buenrostro V, Torre-Bouscoulet L, Torecillas-Torres L, Torres M, Tovar-Guzman V, Turcott-Chaparro JG, Vazquez-Cortes JJ, Vazquez-Manriquez ME, Vilches-Cisneros N, Villegas-Elizondo JF, Zamboni MM, Zamora-Moreno J, Zinser-Sierra JW. [National consensus of diagnosis and treatment of non-small cell lung cancer]. Rev Invest Clin. 2013 Mar;65 Suppl 1:S5-84. Spanish.
Results publication: PubMed 17050868Timmerman R, McGarry R, Yiannoutsos C, Papiez L, Tudor K, DeLuca J, Ewing M, Abdulrahman R, DesRosiers C, Williams M, Fletcher J. Excessive toxicity when treating central tumors in a phase II study of stereotactic body radiation therapy for medically inoperable early-stage lung cancer. J Clin Oncol. 2006 Oct 20;24(30):4833-9. doi: 10.1200/JCO.2006.07.5937.
Results publication: PubMed 26830686Henkenberens C, Janssen S, Lavae-Mokhtari M, Leni K, Meyer A, Christiansen H, Bremer M, Dickgreber N. Inhalative steroids as an individual treatment in symptomatic lung cancer patients with radiation pneumonitis grade II after radiotherapy - a single-centre experience. Radiat Oncol. 2016 Feb 2;11:12. doi: 10.1186/s13014-016-0580-3.
Results publication: PubMed 25276362Kim S, Oh IJ, Park SY, Song JH, Seon HJ, Kim YH, Yoon SH, Yu JY, Lee BR, Kim KS, Kim YC. Corticosteroid therapy against treatment-related pulmonary toxicities in patients with lung cancer. J Thorac Dis. 2014 Sep;6(9):1209-17. doi: 10.3978/j.issn.2072-1439.2014.07.16.
Results publication: PubMed 23909719Ding NH, Li JJ, Sun LQ. Molecular mechanisms and treatment of radiation-induced lung fibrosis. Curr Drug Targets. 2013 Oct;14(11):1347-56. doi: 10.2174/13894501113149990198.
Results publication: PubMed 20583979Williams JP, Johnston CJ, Finkelstein JN. Treatment for radiation-induced pulmonary late effects: spoiled for choice or looking in the wrong direction? Curr Drug Targets. 2010 Nov;11(11):1386-94. doi: 10.2174/1389450111009011386.
Results publication: PubMed 25808113Daley-Yates PT. Inhaled corticosteroids: potency, dose equivalence and therapeutic index. Br J Clin Pharmacol. 2015 Sep;80(3):372-80. doi: 10.1111/bcp.12637. Epub 2015 May 28.
Results publication: PubMed 19962042Leach C, Colice GL, Luskin A. Particle size of inhaled corticosteroids: does it matter? J Allergy Clin Immunol. 2009 Dec;124(6 Suppl):S88-93. doi: 10.1016/j.jaci.2009.09.050.
Results publication: PubMed 28477633Bledsoe TJ, Nath SK, Decker RH. Radiation Pneumonitis. Clin Chest Med. 2017 Jun;38(2):201-208. doi: 10.1016/j.ccm.2016.12.004. Epub 2017 Mar 1.
Results publication: PubMed 28865520Simone CB 2nd. Thoracic Radiation Normal Tissue Injury. Semin Radiat Oncol. 2017 Oct;27(4):370-377. doi: 10.1016/j.semradonc.2017.04.009.
Results publication: PubMed 28596060Vallard A, Rancoule C, Le Floch H, Guy JB, Espenel S, Le Pechoux C, Deutsch E, Magne N, Chargari C. [Medical prevention and treatment of radiation-induced pulmonary complications]. Cancer Radiother. 2017 Aug;21(5):411-423. doi: 10.1016/j.canrad.2017.03.004. Epub 2017 Jun 5. French.
Individual participant dataSharing planned: Yes. The data of the participants will be reported in the publication results.

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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.

Oscar Arrieta, MD MSc contact

015556280400 ext. 71100

ogarrieta@gmail.com

Diana Flores contact

015556280400 ext. 71101

clinicacancerpulmonincan@gmail.com

Oscar Arrieta, MD MSc principal investigator

Instituto Nacional de Cancerologia, Mexico

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inhaled budesonide in people with Radiation Pneumonitis, run by Instituto Nacional de Cancerologia de Mexico at 2 sites in Mexico.

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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Apr 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 Mexico. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Oscar Arrieta, MD MSc (015556280400 ext. 71100, ogarrieta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pneumonitis graded by the Common terminology criteria for adverse event v4.0. (CTCAE v4.0). (time frame: from the beginning of radiotherapy up to 1 year after the 1st session.). The study lists 2 primary outcomes in all. 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 NCT03803787, which also lists 11 linked publications.

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 Apr 2026.