Trial · NCT07388680

Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia

NCT07388680, Phase 2, Phase 3, Recruiting, Beijing Continent Pharmaceutical Co, Ltd.

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia. Trials, record NCT07388680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07388680

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia
NCT number: NCT07388680
Status: Recruiting
Phases: Phase 2, Phase 3
Enrollment: 298 participants, estimated
Lead sponsor: Beijing Continent Pharmaceutical Co, Ltd.
Conditions: Radiation-induced Lung Injury, Immune-related Pneumonia
Interventions: Pirfenidone Capsules （400 mg）, Pirfenidone Capsules（600mg）, Pirfenidone Capsules（0mg）
First posted: 2026-02-05
Last updated: 2026-04-22

Source ClinicalTrials.gov

Registered outcomes31

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Phase II and Phase III: The absolute value of the change in the predicted percentage of lung carbon monoxide diffusion capacity (DLCO% predicted) from the baseline at week 24.	At the 24th week of the experiment	DLCO% is a core indicator for evaluating pulmonary gas exchange function, reflecting the efficiency of oxygen transfer from the alveoli into the bloodstream. It is crucial for the diagnosis and prognosis of interstitial lung disease, pulmonary vascular disease, and similar conditions. DLCO% = measured diffusing capacity of the lung for carbon monoxide ÷ predicted value × 100%. Absolute value change refers to the direct difference between two consecutive measurements (for example, a decrease from 65% to 55% represents an absolute value change of -10%).
Secondary	Phase II and Phase III: The absolute values of the changes in DLCO% at weeks 2, 4, 8, and 16 compared to the baseline.	At weeks 2, 4, 8 and 16 of the trial
Secondary	Phase II and III: Compared with the baseline, the changes in the measured values of pulmonary carbon monoxide diffusion capacity (DLCO) (in units of liters [L]) at weeks 2, 4, 8, 16, and 24.	At weeks 2, 4, 8,16 and 24 of the trial
Secondary	Phase II and Phase III: Changes in forced vital capacity (FVC) (in liters) from baseline at weeks 2, 4, 8, 16, and 24.	At weeks 2, 4, 8,16 and 24 of the trial
Secondary	Phase II and Phase III: The absolute value changes of forced vital capacity as a percentage of the predicted value (FVC%) from baseline at weeks 2, 4, 8, 16, and 24.	At weeks 2, 4, 8,16 and 24 of the trial
Secondary	Phase II and Phase III: Changes in forced expiratory volume in one second (FEV1) (in liters) from baseline at weeks 2, 4, 8, 16, and 24.	At weeks 2, 4, 8,16 and 24 of the trial
Secondary	Phase II and Phase III: The absolute value of the change in forced expiratory volume in one second as a percentage of the predicted value (FEV1%) from baseline at weeks 2, 4, 8, 16, and 24.	At weeks 2, 4, 8,16 and 24 of the trial
Secondary	Phase II and Phase III: Changes in FEV1/FVC from baseline at weeks 2, 4, 8, 16, and 24.	At weeks 2, 4, 8,16 and 24 of the trial
Secondary	Phase II and Phase III: Changes in the St. George's Respiratory Questionnaire (SGRQ) scores from baseline at weeks 4, 8, 16, and 24.	At weeks 4, 8,16 and 24 of the trial	The St. George's Respiratory Questionnaire (SGRQ) score is the standard instrument for assessing health-related quality of life in patients with chronic airway diseases. It comprises 76 items grouped into three domains-symptoms, activity, and disease impact. Each domain score and the overall total score are scaled from 0 to 100: 0 denotes "complete absence of symptoms or limitation," whereas 100 indicates "maximal severity." Higher scores signify a greater adverse effect of the disease on daily life.
Secondary	Phase II and Phase III: Changes in cough score from baseline at weeks 2, 4, 8, 16, and 24.	At weeks 2, 4, 8,16 and 24 of the trial	The cough score is a subjective instrument that quantifies the frequency, intensity, and disruptive impact of cough on daily activities and sleep into a 0-10-point or 0-100-mm scale; zero denotes complete absence of cough, and higher values indicate increasing symptom severity.

1 to 10 of 31Source ClinicalTrials.gov

See all 31 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07388680

GET https://conductscience.org/api/trials/v1/NCT07388680/registered?page=2

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