NCT03123445

Endostar First-line Treatment of Advanced NSCLC

The Efficacy and Safety of Continuous Administration of Endostar Combined With Chemotherapy for Patients With Advanced no Small Cell Lung Cancer: An Open-label, no Randomized Controlled Multicenter Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP（gemcitabine+cisplatin） scheme for first-line advanced non small cell lung cancer and maintenance treatment.

Detailed description

Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP（gemcitabine+cisplatin） scheme for first-line advanced non small cell lung cancer and maintenance treatment. main objectives: PFS (progression-free survival) the secondary goal: ORR (overall response rate), DCR (disease control rate) and OS（overall survival）

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Endostar	Endostar,30mg continuous intravenous injection pump, d1-d7,21 days as one cycle, 4 cycles in total
DRUG	Gemcitabine	Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total
DRUG	Cisplatin	Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-04-01
• Completion: 2019-09-01
• First posted: 2017-04-21
• Last updated: 2017-04-21

Regulatory

• FDA-regulated drug study