Life sciences · Phase 3 Trial
ClinicalTrials.gov · November 2, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT07908745). This is a study registration, not published results. Lead sponsor: Ruijin Hospital. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 276 participants (ESTIMATED). Conditions: Non-Small-Cell Lung Cancer. Interventions: RADIATION: Reduced-Dose Thoracic Radiotherapy; RADIATION: Standard-Dose Thoracic Radiotherapy. Primary outcome measures: 1-Year Progression-Free Survival (PFS) rate , 1 year after randomization. Brief summary: This is a multicenter, open-label, randomized phase III study in older or frail adults with unresectable stage III non-small cell lung cancer (NSCLC) who are considered unsuitable for concurrent chemoradiotherapy. All participants first receive standard induction chemotherapy plus immunotherapy (4-6 cycles), which is part of routine clinical care and not a study intervention. Patients whose cancer responds (complete response, partial response, or stable disease) may then sign informed consent and be randomly assigned 1:1 to receive either reduced-dose thoracic radiotherapy or standard-dose thoracic radiotherapy. After radiotherapy, both groups receive immune checkpoint inhibitor maintenance therapy for at least 6 months. The main goal is to find out whether reduced-dose radiotherapy is not unacceptably worse than standard-dose radiotherapy in controlling the cancer at 1 year, measured by the 1-year progression-free survival rate. The study will also compare side effects, overall survival, tumor response, and treatment completion. About 276 patients will be enrolled at Ruijin Hospital and six collaborating hospitals in China.