NCT04659785

A Study of Fluzoparib Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer（FA-ES-SCLC）

A Single-Arm,Single-Center, Phase Ib/II Clinical Study of Fluzoparib (SHR-3162) Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer（SCLC）

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together as second-line treatment of patients with extensive stage small cell lung cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.

Detailed description

The degree of malignancy of small cell lung cancer is extremely high. About 60% to 70% of patients are diagnosed as extensive. The median survival time of the disease is only 9 to 10 months, and the 2-year survival rate is less than 10%. Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor. Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor.This open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib as second-line treatment of patients with extensive stage small cell lung cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored.

Conditions

• Small Cell Lung Cancer Extensive Stage

Interventions

Type	Name	Description
DRUG	Fluzoparib	Take Fluzoparib orally（either at 50,100mg bid）until disease progression or appearance of unbearable toxicity
DRUG	Apatinib	Take apatinib orally (either at 375mg、500mg、750mg qd）until disease progression or appearance of unbearable toxicity

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-07-31
• Completion: 2022-12-31
• First posted: 2020-12-09
• Last updated: 2020-12-09

Locations

1 site across 1 country: China