A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 as second line therapy in wild-type EGFR Patients with Non-Squamous Non-Small-Cell Lung Cancer. After failure to first line therapy, platinum doublet plus bevacizumab.
- Conditions
- on-Squamous Non-Small-Cell Lung Cancer
- Registration Number
- JPRN-UMIN000009602
- Lead Sponsor
- ung Oncology Group in Kyushu, Japan (LOGIK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
(1) squamous metastasis (2) activating EGFR sensitive mutation or unknown(sensitive EGFR mutation:G719X, exon19deletion,L858R,L861Q) (3) having serious complications. ex): a serious heart disease , cerebrovascular disorder, diabetes that it is hard to control or hypertention , a severe infection, pulmonary fibrosis, interstitial pneumonia, respiratory failure, bleeding, a large quantity of hydrothorax or abdominal dropsy retention, peptic ulcer of the activity, serious nerve disease (4) symptomatic brain metastasis (5) have an anamnesis and the complications , expectoration of fresh blood more than 2.5 ml due to non-small-cell lung cancer (6) having an anamnesis of the following bloody phlegm or complications * there is the dosage career when bloody phlegm occurring continuously (more than one week) or the anamnesis or the internal use styptic is continuous(the cases that an internal use styptic was necessary for again after having been relieved using an internal use styptic or the bloody phlegm which needs with a history of bloody phlegm, the dosage of the injection styptic to need the dosage or the dosage) (7) current or previous (within the last 1 year) history of GI perforation (8) the operation has been scheduled for the examination period (9) have multiple primary cancer (10) history of serious drug hypersensitivity (11) pregnancy or lactation (12) active psychological disease (13) receives the steroid continuously(p.o. or i.v.) (14) any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Response rate Disease control rate Overall survival Adverse events