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

NCT04106180 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2019-09-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhengfei Zhu, MD · Fudan University

  • Xinghao Ai · Shanghai Chest Hospital

  • Zhengbo Han · Shengjing Hospital

  • Qian Chu · Tongji Hospital

  • Xiaorong Dong · Union Hospital

  • Lin Wu · Hunan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2022-08-31
Completion
2023-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106180 on ClinicalTrials.gov