Having just 86 patients enrolled makes the bavi study more difficult to interpret. A smaller study is also more susceptible to differences in baseline characteristics of patients, so it will be important to see whether there are any significant differences in the patients enrolled in each arm of the study.
The bavi study is open label, meaning doctors and patients know if they're receiving bavi plus chemo or chemo alone. Open-label studies are more prone to biased results unless data is independently verified.
Peregrine's phase II study is enrolling lung cancer patients at 17 hospitals in the U.S., nine sites in India and 14 sites in Eastern Europe and Russia, according to a description of the study on ClinicalTrials.gov. Avastin plus chemo is the standard-of-care treatment for front-line lung cancer in the U.S., so how is Peregrine managing to enroll U.S. patients in a study that excludes Avastin?
Says Peregrine: "Avastin is not indicated for all front-line NSCLC
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