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A Phase I/II, Open Label, Dose-Escalating Study Evaluating the Safety and Efficacy of the Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody EMD 72000 (Matuzumab) in Combination with the...

Update Il y a 4 ans
Reference: EUCTR2006-000871-13

A Phase I/II, Open Label, Dose-Escalating Study Evaluating the Safety and Efficacy of the Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody EMD 72000 (Matuzumab) in Combination with the EGFR Tyrosine Kinase Inhibitor Tarceva (Erlotinib) in Subjects with Recurrent Advanced Non-Small-Cell Lung Cancer

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Extract

Primary Objective Phase I: •To determine the safety of matuzumab in combination with erlotinib in up to 5 different dose cohorts. Primary Objective Phase II: •To determine the tumor response rate (RR; defined as complete response [CR] plus partial response [PR]) of matuzumab in combination with erlotinib, at a single dose chosen from phase I, according to the modified World Health Organization (WHO) criteria as assessed by an Independent Review Committee (IRC).

Inclusion criteria

  • Stage IIIB/IV non-small cell lung cancer and progressive disease after first-line treatment with a platinum analogue in comination with taxanes, gemcitabine, or vinorelbine

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