NCT05603013

Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer(PRaG 6.0)

Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Inhibitor Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer (PRaG 6.0)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, Phase II investigator-initiated trial of vinorelbine metronomic chemotherapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory non-small cell lung cancer and breast cancer.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Carcinoma Breast

Interventions

Type	Name	Description
DRUG	Vinorelbine	Vinorelbine Tartrate Oral
RADIATION	Radiotherapy	hypofractionated radiotherapy
DRUG	PD-1/PD-L1 inhibitor	PD-1/PD-L1 inhibitor subcutaneous injection or intravenous injection
DRUG	GM-CSF	GM-CSF subcutaneous injection
DRUG	IL-2	IL-2 subcutaneous injection

Timeline

• Start date: 2022-10-30
• Primary completion: 2024-01-01
• Completion: 2024-10-17
• First posted: 2022-11-02
• Last updated: 2022-11-02

Locations

1 site across 1 country: China