NCT04106180

SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC

An Open-label, Multicenter, Phase II Single Arm Trial of SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multicenter, phase II single arm trial to evaluate the efficacy and safety of SBRT in combination with sintilimab and GM-CSF for the treatment of patients with advanced NSCLC.

Conditions

• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	GM-CSF	Patients will receive GM-CSF 125μg/m2 daily for 14 consecutive days after completing SBRT treatment.
DRUG	Sintilimab	Patients will receive Sintilimab 200 mg every 3 weeks up to 2 years after completing SBRT treatment.
RADIATION	SBRT	Patients will receive SBRT for one previously unirradiated primary or metastatic lesion (size: 1-5cm). 24 Gy in 3 fractions (8Gy/Fx) administered once-daily for 3 consecutive days.

Timeline

• Start date: 2019-09-30
• Primary completion: 2022-08-31
• Completion: 2023-08-31
• First posted: 2019-09-26
• Last updated: 2019-09-26

Locations

1 site across 1 country: China