A Multicenter, Open Label, Randomized Study of AMG 951 in Subjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without Bevacizumab

Update Il y a 4 ans
Reference: EUCTR2005-005484-28

Woman and Man

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Extract

Phase 1b Primary Objective: To determine the maximum tolerated dose (MTD) (up to 8 mg/kg/day for 5 days treatment and up to 20mg/kg/day for 2 days treatment) through safety and tolerability of multiple doses of AMG 951 administered by intravenous (IV) infusion to subjects with NSCLC in combination with chemotherapy and bevacizumab. Phase 2 Primary Objective: To evaluate the objective response rate (CR and PR) by modified RECIST for AMG 951 at varying dose schedules in combination with carboplatin / paclitaxel + bevacizumab for subjects with NSCLC.


Inclusion criteria

  • Subjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without Bevacizumab