Trial Identifiers
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Scientific Title
Phase 2 trial of sotorasib in combination with carboplatin-pemetrexed and bevacizumab-biosimilar as first line treatment for advanced non-squamous non-small cell lung cancer with KRAS G12C mutation
Cooperative Group
Thoracic Oncology Group of Australasia
Commercial Sponsor
AMGEN
Other Non-Commercial Sponsor
University of Sydney
Summary
Eligible participants will all receive treatment with targeted therapy (sotorsib and bevacizumab-biosimilar) and combination chemotherapy (carboplatin-pemetrexed). Treatment will be given in two stages: Induction and Maintenance. The Induction stage consists of 4 x 3 weekly cycles of sotorasib (960mg, oral tablets daily) plus pemetrexed (500mg/m2 on Day 1 every 3 weeks via intravenous infusion) plus carboplatin (total dose not exceeding 750mg and calculated for each participant using the Calvert method, on Day 1 every 3 weeks via intravenous infusion) plus bevacizumab-biosimilar (15mg/kg, Day 1 every 3 weeks via intravenous infusion). In the Maintenance stage, participants will receive sotorasib (960mg, oral tablets daily) plus Pemetrexed (500mg/m2 on Day 1 every 3 weeks via intravenous infusion ) plus bevacisumab-biosimilar (15mg/kg, Day 1 every 3 weeks via intravenous infusion).