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Completed

NCT Number: NCT01099124

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

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

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University Cancer Institude and Hospital

Tianjin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

M2ES

Drug

polyethylene glycol rh recombinant endostatin

Primary outcomes

  1. Adverse events incidence,including severe adverse events incidence

    Time frame: one year

Secondary outcomes

  1. Tumor response rate and disease controlled rate

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

Single-center, Open Trail of Phase 1 of M2ES With TC Regimen in Advanced NSCLC

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2010
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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