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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab
  • High-Low Mixed-Dose Radiotherapy Group

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators