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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 25, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT05269485). This is a study registration, not published results. Lead sponsor: Anhui Provincial Hospital. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 36 participants (ACTUAL). Conditions: Non-small Cell Lung Cancer, Radiotherapy Side Effect. Interventions: RADIATION: High-dose hypofractionated radiotherapy; RADIATION: Low-dose hypofractionated radiotherapy. Primary outcome measures: Rate of radiation-induced pneumonitis (CTCAE V4.0) , 1 to 2 years; Rate of radiation-induced esophagitis (CTCAE V4.0) , 1 to 2 years; Rate of central hilar structure injury (CTCAE V4.0) , 1 to 2 years; Rate of hematologic toxicity , 1 to 2 years. Brief summary: Definitive concurrent chemoradiotherapy followed by durvalumab (Pacific protocol) has been the standard modality for stage III locally advanced non-small cell lung cancer. In spite of the median overall survival of 47.5 months, there still existed 38.5% and 6.9% patients who finally developed intra-thorax and extra-thorax recurrence respectively in long-term follow-up. The relatively low local control rate has been the bottleneck for further improvement of overall survival. Hypofraction radiotherapy has been validated to be able to increase the local control rate in two prospective trials. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy followed by immune checkpoint inhibitors for stage III locally advanced non-small cell lung cancer.