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NOT YET RECRUITING
NCT07418866
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-02

Completion Date

2028-12

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

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