NCT07131319

SFRT+Tislelizumab+Platinum Chemotherapy for Unresectable Stage III NSCLC

Spatially Fractionated Radiotherapy (SFRT) Synchronized With Tislelizumab Plus Platinum-based Dual-agent Chemotherapy for Induction Treatment of Initially Unresectable Stage Ⅲ Non-small Cell Lung Cancer: A Clinical Study

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to understand whether spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment is effective in treating initially unresectable stage Ⅲ non-small cell lung cancer (NSCLC). It will also explore the safety of this treatment modality. The main questions it aims to answer are: Will spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment increase the surgical resection rate of patients with initially unresectable stage Ⅲ non-small cell lung cancer? What adverse reactions will patients experience when receiving spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment?

Detailed description

Research Title: A Clinical Study on Induction Treatment with Spatial Fractionated Radiotherapy (SFRT) Concurrent with Tislelizumab Plus Platinum-based Doublet Chemotherapy for Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) Research Objective: To explore the efficacy and safety of induction treatment with spatial fractionated radiotherapy (SFRT) concurrent with tislelizumab plus platinum-based doublet chemotherapy for initially unresectable stage III non-small cell lung cancer (NSCLC). Design Type: Interventional Study Research Subjects: Patients with non-small cell lung cancer diagnosed by pathological histology or cytology, staged as stage III (T3 - 4N1 - 2M0) according to the 8th edition of AJCC, defined as initially unresectable by the multidisciplinary team (MDT), without known EGFR and ALK mutations, aged ≥ 18 years old, with an ECOG PS score of 0 - 1. Sample Size: 30 cases

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Spatially Fractionated Radiotherapy (SFRT)	Several spherical volumes (with a diameter of 1 cm) are selected within the hypoxic area of the primary tumor. The distance between each spherical volume is 1.5 - 2 cm, and a high-dose radiotherapy of 12 Gy × 1F is delivered.
DRUG	Tislelizumab, Carboplatin, Pemetrexed	For adenocarcinoma, pemetrexed (500 mg/m², day 1) + carboplatin (AUC 5, day 1) is used.
DRUG	Tislelizumab, paclitaxel, Carboplatin	For NSCLC with pathological types other than adenocarcinoma, nab-paclitaxel (100 mg/m² on day 1 and day 8) + carboplatin (AUC 5, day 1) is used.

Timeline

• Start date: 2025-04-21
• Primary completion: 2026-04-15
• Completion: 2026-04-15
• First posted: 2025-08-20
• Last updated: 2026-02-02

Locations

1 site across 1 country: China