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.
Signed written informed consent obtained prior to the initiation of any trial-related procedures.
Age > 18 years.
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
Negative for driver gene mutations (EGFR, ALK, ROS1, RET, MET exon 14 skipping, HER2, BRAF, KRAS G12C).
Patients with severe emphysema, interstitial lung changes, or COPD;
Resting blood oxygen saturation < 93%;
History of other malignancies requiring chemotherapy within the past 2 years;
History of thoracic radiotherapy;
Parallel
Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab
DrugPaclitaxel Micelles 100 mg/m²; Cisplatin 30 mg/m² ; 5-FU 1200 mg/m²; Serplulimab 200 mg
High-Low Mixed-Dose Radiotherapy Group
RadiationA 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
Objective Response Rate
Tumor Volume Reduction Rate
PET-CT Negative Conversion Rate
The incidence of ≥ Grade 2 radiation pneumonitis
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