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


N/A
18 Years
70 Years
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events incidence,including severe adverse events incidence

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

Kai LI

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tianjin Medical University Cancer Institude and Hospital

Authority:

China: Food and Drug Administration

Study ID:

TMU-CIH-CTI-001

NCT ID:

NCT01099124

Start Date:

December 2009

Completion Date:

September 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • M2ES
  • NSCLC
  • Phase I Trial
  • Advanced NSCLC
  • Recurrent NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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