Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701)
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000030603
- Lead Sponsor
- Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival from the start of treatment
- Secondary Outcome Measures
Name Time Method response rate, disease control rate, overall survival, safety