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

Tianjin Medical University

Status: Completed

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: M2ES

Study type: Interventional

Funder types: Other

Identifiers

NCT01099124

TMU-CIH-CTI-001

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

M2ES combined with chemotherapy

Experimental group

Treatment:

Drug: M2ES