NCT03706703

Rh-Endostatin (Endostar®) Continuous Intravenous Infusion

The Safety and Efficacy of Rh-Endostatin (Endostar®) Continuous Intravenous Infusion in Combination With Docetaxel/Carboplatin or Pemetrexed/Carboplatin (DC/PC) Regimens for Untreated Stage IIIB/IV Non-small-cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Endostar	continuous intravenous infusion Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.
DRUG	Docetaxel	docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle
DRUG	Carboplatin	carboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed
DRUG	Pemetrexed	pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-04-01
• Completion: 2020-09-01
• First posted: 2018-10-16
• Last updated: 2018-10-17

Locations

1 site across 1 country: China