Trial reportInternational journal of radiation oncology, biology, physics2023
Randomized Phase 2 Placebo-Controlled Trial of Nintedanib for the Treatment of Radiation Pneumonitis.
Trial report in International journal of radiation oncology, biology, physics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.
- Pooled it
- Biomarkers associated with pulmonary exacerbations in a randomized trial of nintedanib for radiation pneumonitis.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2024Trial
- Cost-effectiveness of pirfenidone for patients with cancer and grade 2 or grade 3 radiation-induced lung injury: A modeling study.PLoS medicine · 2026Article
- Research progresses on the regulatory roles of microRNAs in radiation-induced pulmonary fibrosis.Journal of molecular histology · 2026Review
- Radiomitigators: Breakthroughs in Post-Radiation Recovery.Antioxidants (Basel, Switzerland) · 2026Review
- Molecular mechanisms and network interactions in radiation-induced lung injury.Frontiers in physiology · 2026Review
- Targeting Oxidative and Nitrosative Stress: Mechanistic Insights and Therapeutic Strategies for Radiation-Induced Lung Injury.Journal of inflammation research · 2026Review
- Hypothesis-driven salvage therapy with corticosteroids, tofacitinib, and nintedanib for progressive radiation pneumonitis with possible immune-mediated contribution: a case report.Frontiers in immunology · 2026Article
- Article
- Radiation-induced lung injury in the era of combination anticancer therapy: a narrative review.Frontiers in immunology · 2026Review
- Effectiveness and safety of pirfenidone for radiation-induced lung injury in non-small cell lung cancer: a retrospective pilot study.BMC cancer · 2025Article
- Pleural mesothelioma.Nature reviews. Disease primers · 2025Review
- Case Report: Grade 4 pneumonitis occurred after thoracic radiotherapy and dacomitinib in a patient with lung adenocarcinoma.Frontiers in oncology · 2025Article
- Article
- [Nintedanib for the treatment of radiation pneumonitis].Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2024Article
- Noninvasive Quantification of Radiation-Induced Lung Injury Using a Targeted Molecular Imaging Probe.International journal of radiation oncology, biology, physics · 2024Article
- Nintedanib Mitigates Radiation-Induced Pulmonary Fibrosis by Suppressing Epithelial Cell Inflammatory Response and Inhibiting Fibroblast-to-Myofibroblast Transition.International journal of biological sciences · 2024Article
- Radiation-Induced Lung Injury With Lung Cancer Treated With the Combination Therapy of Nintedanib and Dexamethasone.Cureus · 2023Article
- Radiation-triggered acute exacerbation of progressive fibrotic interstitial lung diseases: 'Are we advancing the frontier or crossing a dangerous line?'Therapeutic advances in respiratory diseaseReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 4 institutions in 1 country.
Funding
Abstract
purposeRadiation pneumonitis (RP) is the most common dose-limiting toxicity for thoracic radiation therapy. Nintedanib is used for the treatment of idiopathic pulmonary fibrosis, which shares pathophysiological pathways with the subacute phase of RP. Our goal was to investigate the efficacy and safety of nintedanib added to a prednisone taper compared with a prednisone taper alone in reducing pulmonary exacerbations in patients with grade 2 or higher (G2+) RP. METHODS AND MATERIALS: In this phase 2, randomized, double-blinded, placebo-controlled trial, patients with newly diagnosed G2+ RP were randomized 1:1 to nintedanib or placebo in addition to a standard 8-week prednisone taper. The primary endpoint was freedom from pulmonary exacerbations at 1 year. Secondary endpoints included patient-reported outcomes and pulmonary function tests. Kaplan-Meier analysis was used to estimate the probability of freedom from pulmonary exacerbations. The study was closed early due to slow accrual.
resultsThirty-four patients were enrolled between October 2015 and February 2020. Of 30 evaluable patients, 18 were randomized to the experimental Arm A (nintedanib + prednisone taper) and 12 to the control Arm B (placebo + prednisone taper). Freedom from exacerbation at 1 year was 72% (confidence interval, 54%-96%) in Arm A and 40% (confidence interval, 20%-82%) in Arm B (1-sided, P = .037). In Arm A, there were 16 G2+ adverse events possibly or probably related to treatment compared with 5 in the placebo arm. There were 3 deaths during the study period in Arm A due to cardiac failure, progressive respiratory failure, and pulmonary embolism.
conclusionsThere was an improvement in pulmonary exacerbations by the addition of nintedanib to a prednisone taper. Further investigation is warranted for the use of nintedanib for the treatment of RP.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.