NCT02513355

Endostar Treatment of Advanced Non-small Cell Lung Cancer Multi-center Clinical Research

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Nanjing NingQi Medicine Science and Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Research purpose: Degree of continuous intravenous pumping Endostar (human recombinant endostatin) combination chemotherapy regimens including cisplatin two medicine first-line treatment of advanced non-small cell lung cancer (with the exception of EGFR/ALK mutations) efficacy and safety.

Detailed description

1.Research purpose: Degree of continuous intravenous pumping Endostar (human recombinant endostatin) combination chemotherapy regimens including cisplatin two medicine first-line treatment of advanced non-small cell lung cancer (with the exception of EGFR/ALK mutations) efficacy and safety. 2.1 main objectives: PFS 2.2 the secondary goal: 2.2. 1 ORR, DCR and OS 2.2. 2 the quality of life 3. The study design 3.1 research nature This is a single arm, multicenter clinical study, is expected to total 100 patients into the group. Hierarchical factors include: the tumor staging (Ⅲ B vs Ⅳ), ECOG score (0 v 1), gender (male vs female). 3.2 research center and research Proposed by taizhou people's hospital and medical association of jiangsu province tumor chemotherapy and biological branch of the lung cancer group led by several large and medium-sized hospitals in the province of the malignant tumor treatment related department to participate, in accordance with the unified test plan of this research.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Endostar	Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles
DRUG	Changchun marina	25mg/m2,d1 and d8,q21d×4
DRUG	cisplatin	80mg/m2,d1, q21d×4
DRUG	Taxol	135-175mg/m2,d1,q21d×4
DRUG	parapl	AUC=5-6,d1,q21d×4

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-11-01
• First posted: 2015-07-31
• Last updated: 2015-08-04

Locations

1 site across 1 country: China