drugset / Trial / NCT07418866

FANLUNG-2:The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung Cancer

NCT07418866

Phase 2 Not yet recruiting 70 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-02
Primary completion
2028-02
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 30 mg/m2
Subject Paclitaxel Small molecule 100 mg/m2
Subject Serplulimab Monoclonal antibody 200 mg
Subject fluorouracil Small molecule 1200 mg/m2