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
Study ID
NCT07418866
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab — DRUG
    Paclitaxel Micelles 100 mg/m²; Cisplatin 30 mg/m² ; 5-FU 1200 mg/m²; Serplulimab 200 mg
  • High-Low Mixed-Dose Radiotherapy Group — RADIATION
    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

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Feb 29, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemo-immunotherapy + High-Low Mixed-Dose Radiotherapy Group
    Two cycles of chemo-immunotherapy (Paclitaxel Micelles 100 mg/m²; Cisplatin 30 mg/m²; 5-FU 1200 mg/m²; Serplulimab 200 mg); central ablative radiotherapy: for large masses (short diameter \> 2 cm), the central 1/4 region receives 15-20 Gy/1 fraction, with the 5 Gy isodose line not exceeding the GTV, and maximum doses to the esophagus, trachea, and spinal cord kept below 3 Gy; low-dose radiotherapy: for small masses (short diameter \< 2 cm), 2 Gy/1 fraction. Efficacy evaluation is performed before the third chemotherapy cycle, along with radiotherapy simulation. The fourth chemotherapy cycle is administered concurrently during radiotherapy. Immunotherapy is initiated 1-42 days after radiotherapy completion and maintained for 2 years.
  • Active Comparator: Chemo-immunotherapy Group
    2 cycles of chemoradiotherapy (Paclitaxel (micellar) 100 mg/m²; Cisplatin 30 mg/m²; 5-Fluorouracil 1200 mg/m²; Serplulimab 200 mg). Efficacy evaluation will be conducted prior to the 3rd chemotherapy cycle, along with radiotherapy simulation. The 4th chemotherapy cycle will be administered concurrently with radiotherapy. Immunotherapy maintenance will begin within 42 days after completion of radiotherapy and continue for 2 years.

Primary Outcome Measure

Objective Response Rate [ Time Frame: At the end of Cycle 2 chemo- immune therapy (each cycle is 21 days) ]

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