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Reduced-Dose vs Standard-Dose Thoracic Radiotherapy After Induction Chemoimmunotherapy in Older or Frail Stage III NSCLC
Sponsor: Ruijin Hospital
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.
Official title: Reduced-Dose Versus Standard-Dose Thoracic Radiotherapy After Induction Chemo-Immunotherapy in Older/Frail Patients With Locally Advanced Non-Small Cell Lung Cancer: An Open-Label, Multicenter, Non-Inferiority, Phase III Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
276
Start Date
2026-10-30
Completion Date
2031-12-03
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Reduced-Dose Thoracic Radiotherapy
After 4-6 cycles of standard induction chemotherapy plus immunotherapy and confirmation of CR/PR/SD by RECIST 1.1, participants receive thoracic radiotherapy to the involved tumor and metastatic lymph nodes using IMRT/VMAT. The prescribed dose is 50-54 Gy in 25-27 fractions (2.0 Gy/fraction, 5 fractions/week, about 5 weeks). No concurrent immune checkpoint inhibitor (ICI) is given during radiotherapy. After radiotherapy, participants receive ICI maintenance therapy for at least 6 months (8 cycles) or until disease progression, unacceptable toxicity, or death. This arm is distinguished from the comparator by the lower radiation dose and fewer fractions.
Standard-Dose Thoracic Radiotherapy
After 4-6 cycles of standard induction chemotherapy plus immunotherapy and confirmation of CR/PR/SD by RECIST 1.1, participants receive thoracic radiotherapy to the involved tumor and metastatic lymph nodes using IMRT/VMAT. The prescribed dose is 60-66 Gy in 30-33 fractions (2.0 Gy/fraction, 5 fractions/week, about 6 weeks). No concurrent immune checkpoint inhibitor (ICI) is given during radiotherapy. After radiotherapy, participants receive ICI maintenance therapy for at least 6 months (8 cycles) or until disease progression, unacceptable toxicity, or death. This arm is distinguished from the experimental arm by the higher standard radiation dose and more fractions.