Non Small Cell Lung Cancer
Conditions
Keywords
M2ES, NSCLC, Phase I Trial, Advanced NSCLC, Recurrent NSCLC
Brief summary
The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.
Interventions
DRUGM2ES
polyethylene glycol rh recombinant endostatin
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events incidence,including severe adverse events incidence | one year |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response rate and disease controlled rate | one year |
Countries
China
Outcome results
None listed