Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase 1b Trial Evaluating the Safety of Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in Subjects With Previously Untreated Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
The primary purpose of this study is to examine the safety of volociximab (V) in combination with a standard treatment of carboplatin (C), paclitaxel (P), and bevacizumab (B) in subjects previously untreated with chemotherapy for advanced stage (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC).
Phase 1b, multicenter, open-label, dose-escalation study to evaluate the safety and
tolerability of volociximab in combination with C/P + B in subjects with previously
untreated Stage IIIB/IV non-squamous NSCLC.
Subjects will be treated with the C/P + B + volociximab (V)combination for a total of 6
cycles (3 weeks/cycle). Subjects with stable disease (SD)or better per Response Evaluation
Criteria in Solid Tumors (RECIST)after the 6th cycle of combination treatment (C/P + B + V)
will be considered for further treatment in a maintenance phase with B + V at the same dose
until subject withdrawal from treatment.
Volociximab will be administered at doses ranging from 10 to 30 mg/kg every 3 weeks.
Paclitaxel, carboplatin, and bevacizumab will be administered at their registered doses for
this combination.
Follow up for each subject will extend over a 90-day period following the last dose of
volociximab. End of study is defined as 90 days after the last dose of volociximab for the
last subject treated in the study.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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