NCT07418866

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

Type	Name	Description
DRUG	Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab	Paclitaxel Micelles 100 mg/m²; Cisplatin 30 mg/m² ; 5-FU 1200 mg/m²; Serplulimab 200 mg
RADIATION	High-Low Mixed-Dose Radiotherapy Group	A high-low mixed-dose irradiation approach: for large lesions (short diameter \> 2 cm), central ablative radiotherapy is applied, delivering a single ablative dose of 15-20 Gy to approximately one-quart

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-02-01
• Completion: 2028-12-01
• First posted: 2026-02-18
• Last updated: 2026-02-18