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The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung Cancer - A Prospective, Open-Label, Randomized Controlled, Phase II Study (FANLUNG-2)
Moving immunotherapy ahead of chemoradiotherapy in a "sandwich" model-where tumor reduction is achieved through induction chemo-immunotherapy, immunotherapy is paused during chemoradiotherapy, and then resumed as maintenance post-radiotherapy-has shown promising potential. However, this approach still faces two main challenges: insufficient depth of tumor response and an increased risk of radiation pneumonitis.To address these issues, we investigators have designed a novel high-low mixed-dose irradiation strategy. This approach, combined with two cycles of induction chemo-immunotherapy, aims to achieve rapid tumor regression, improve disease control rates, and reduce overall lung radiation exposure.
Details
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 70 |
| Start date | 2026-02 |
| Completion | 2028-12 |
Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer)
Interventions
- Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab
- High-Low Mixed-Dose Radiotherapy Group
Primary outcomes
- Objective Response Rate — At the end of Cycle 2 chemo- immune therapy (each cycle is 21 days)