non-small cell lung cancer
Conditions
Interventions
Docetaxel (60 mg / m 2, day 1) + Ramucirumab (10 mg/kg, day 1) and PEG-G-CSF(3.6 mg, day 2) every 3 weeks until progression or both docetaxel and rRamucirumab termination.
Sponsors
Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years old or older. 2) Histologically or pathologically proven non-squamous NSCLC with EGFR mutation. 3) Cases with a history of treatment with EGFR-TKI and platinum combination therapy. 4) Presence of measurable lesions on RECIST ver.1.1. 5) Eastern Cooperative Oncology Group (ECOG) performance status: 0-2. 6) Stage 3B, 4, or recurrence, two weeks or more have passed since the completion of radiotherapy. 7) Life expectancy of more than 3 months. 8) Written informed. 9) major organs are held by the examination value within 30 days and clinical examination at the start of treatment meets the following criteria Neut >= 1,500/mm3 Hb >= 9.0 g/dL CRE <= 1.5 mg/dL T-bil <= 1.5 mg/dL AST/ALT <= 100 IU/L (<= 200 IU/L by liver metastases) Protein uria <= 1+
Exclusion criteria
Exclusion criteria: 1) Diagnosed as squamous cell carcinoma 2) History of hemoptysis(=>2.5mL) 3) Bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation 4) With thromboembolism 5) Peptic ulcer, gastrointestinal perforation, intestinal diverticulitis, inflammatory bowel disease combined 6) Tumor invasion in the blood vessel. 7) Symptomatic brain metastasis. 8) Exposure of the tumor to the central airway 9) With third-space fluid need to be drained. 10) Active double cancers within 5 years(cured intraepithelial carcinoma and intramucosal carcinoma are not included). 11) With severe complications Intestinal palsy, intestinal obstruction Interstitial pneumonia or pulmonary fibrosis Superior vena cava syndrome Difficult-to-control diabetes, hypertension, liver disorder, angina pectoris, congestive heart failure and myocardial infarction within 3 months after onset Cases with complications of severe infection or cases suspected of severe infection Cases with complications that are deemed to cause serious obstruction to treatment enforcement 12)Anticoaglation with aspirin (> 325 mg / day) or clopidogrel (> 75 mg / day). Prophylactic use of anticoagulants is acceptable). 13)Pregnant or breastfeeding women. Willing to get pregnant. Severe psychological disease 14)Judgment to attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival from the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, disease control rate, overall survival, safety | — |
Countries
Japan
Contacts
Public ContactShogo Sakurai
Hamamatsu university school of medicine Second Division, Department of Internal Medicine
Outcome results
None listed