NCT04167657

SinTilimab After Radiation (STAR Study)

A Phase II Single-arm Study of Sintilimab After Thoracic Radiation in Previously Treated Advanced NSCLC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm multi-center phase II clinical study, which aims to investigate the efficacy and safety of sintilimab after radiotherapy in patients with advanced NSCLC who failed first-line or second-line systemic treatment.

Conditions

• Carcinoma, Non-Small Cell Lung

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 24 months. Before enrollment, patient should undergo radiation no less than dose 30Gy( 6 Gy × 5, or other ), or the planned dose could reach 30 Gy. Sintilimab shall be started no later than 3 weeks after radiation. Radiotherapy can be performed on the same day as sintilimab.

Timeline

• Start date: 2019-04-15
• Primary completion: 2023-11-30
• Completion: 2024-04-30
• First posted: 2019-11-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China