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RECRUITING
NCT07131319
PHASE2/PHASE3

SFRT+Tislelizumab+Platinum Chemotherapy for Unresectable Stage III NSCLC

Sponsor: Second Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

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?

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-04-21

Completion Date

2026-04-15

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

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.

Locations (1)

Nanchang City, Jiangxi Province

Nanchang, Jiangxi, China