Trial reportInternational journal of radiation oncology, biology, physics2023
Dose-Limiting Pulmonary Toxicity in a Phase 1/2 Study of Radiation and Chemotherapy with Ipilimumab Followed by Nivolumab for Patients With Stage 3 Unresectable Non-Small Cell Lung Cancer.
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 11 papers.
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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.
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Who cites it
11 citing papers in PubMed, 18 citations in OpenAlex.
- Single-arm trial of neoadjuvant ipilimumab plus nivolumab with chemoradiotherapy in patients with resectable and borderline resectable lung cancer: the INCREASE study.Journal for immunotherapy of cancer · 2024Trial
- Assessment of pneumonitis in patients with lung cancer undergoing radioimmunotherapy and immune checkpoint inhibitor rechallenge.Communications medicine · 2026Article
- Immunotherapy combined with radiotherapy for advanced non-small cell lung cancer: Current status and challenge (Review).Oncology letters · 2025Review
- Chemotherapy-Free Treatment with Radiotherapy and Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer.Cancers · 2025Review
- Unraveling the synergy of radiotherapy and immune checkpoint inhibitors in NSCLC: emerging clinical evidence and novel therapeutic strategies.Frontiers in oncology · 2025Review
- Combined Albumin Polyester Nanocarriers with Docetaxel for Effective Against Lung Cancer in Mice Model.International journal of nanomedicine · 2025Article
- Stereotactic ablative radiation therapy for extracranial metastases from malignant melanoma: An international multi-institutional analysis.Journal of radiosurgery and SBRT · 2025Article
- Radiosensitization effect of quinoline-indole-schiff base derivative 10E on non-small cell lung cancer cells in vitro and in tumor xenografts.Investigational new drugs · 2024Article
- Factors associated with failure to start consolidation durvalumab after definitive chemoradiation for locally advanced NSCLC.Frontiers in oncology · 2023Article
- Review
- New challenges in the combination of radiotherapy and immunotherapy in non-small cell lung cancer.World journal of clinical oncology · 2021Review
Corrections and comments
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Authors and funding
25 authors at 3 institutions in 1 country.
Funding
Abstract
purposeWe hypothesized that concurrent ipilimumab with chemoradiationtherapy (chemoRT) followed by maintenance nivolumab would be safe for patients with unresectable stage III non-small cell lung cancer (NSCLC). We aimed to assess the safety (phase 1) and the 12-month progression-free survival (PFS) (phase 2) in a multi-institution prospective trial. METHODS AND MATERIALS: Eligible patients had unresectable stage III NSCLC. The treatment included platinum doublet chemotherapy with concurrent thoracic radiation therapy to 60 Gy in 30 fractions and ipilimumab (1 mg/kg) delivered during weeks 1 and 4. After chemoRT, maintenance nivolumab (480 mg) was given every 4 weeks for up to 12 cycles. Adverse events (AEs) were assessed according to the Common Terminology Criteria for Adverse Events, version 5.0. Survival analyses were performed with Kaplan Meier (KM) methods and log-rank tests.
resultsThe trial was discontinued early after enrolling 19 patients without proceeding to the phase 2 component because of unacceptable toxicity. Sixteen patients (84%) had grade ≥3 (G3+) possible treatment-related toxicity, most commonly pulmonary AEs (n = 8, 42%). Fourteen patients (74%) discontinued study therapy early because of AEs (n = 12, 63%) or patient choice (n = 2, 11%). Eleven patients (58%) experienced G2+ pulmonary toxicity with median time to onset 4.1 months (95% CI 2.6-not reached [NR]), and 12-month freedom from G2+ pulmonary toxicity 37% (95% CI, 16-59). Five patients had G5 AEs, including 3 with G5 pulmonary AEs (1 respiratory failure with pneumonitis and pulmonary embolism, 1 pneumonia/chronic obstructive pulmonary disease exacerbation, 1 pulmonary fibrosis). Despite toxicities, the median PFS was 19.2 months (95% CI 6.1-NR) and the median overall survival was NR (95% CI 6.1-NR) with median follow-up of 30.1 months by the reverse KM method.
conclusionsConcurrent ipilimumab with chemoRT for unresectable stage III NSCLC is associated with pulmonary toxicity that may limit opportunities for improved outcomes. Future studies aiming to incorporate ipilimumab or other anti-CTLA4 therapies into management of unresectable stage III NSCLC should consider careful measures to minimize toxicity risk.
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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.