Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)

Not Applicable

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: M2ES

• Registration Number: NCT01099124
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-02-24
• Status Verified: 2010-04
• Study First Submitted QC: 2010-04-05
• Study First Posted: 2010-04-06
• Primary Completion: 2011-07
• Study Completion: 2011-09
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Aged 18-70 years old;
2. Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
3. No contraindication for chemotherapy;
4. ECOG performance scale 0-2;
5. No history of anti-angiogenesis therapy;
6. Patients are voluntary to participate and sigh the informed contents.

Exclusion Criteria

1. Concurrent use of other anti-cancer agents;
2. Allergic history to M2ES and biological agents;
3. Pregnant or breast-feeding women;
4. With other malignancy;
5. With severe cardiopulmonary disease;
6. Uncontrolled brain metastasis patients;
7. Other conditions that are regarded for exclusion by the trialists.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
M2ES combined with chemotherapy	M2ES	-

Primary Outcome Measures

Name	Time	Method
Adverse events incidence,including severe adverse events incidence	one year

Secondary Outcome Measures

Name	Time	Method
Tumor response rate and disease controlled rate	one year

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institude and Hospital; 🇨🇳 Tianjin, China