A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE IIIb TRIAL COMPARING BEVACIZUMAB THERAPY WITH OR WITHOUT ERLOTINIB AFTER COMPLETION OF CHEMOTHERAPY WITH BEVACIZUMAB FOR THE FIRST-LINE TREATMENT OF LOCALLY ADVANCED, RECURRENT, OR METASTATIC NON–SMALL CELL LUNG CANCER

Femme et Homme

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Extrait

The primary objective of this Phase IIIb study is to compare PFS in subjects randomized to bevacizumab + erlotinib versus bevacizumab + erlotinib-placebo in subjects with NSCLC who have completed four cycles of chemotherapy and bevacizumab without disease progression or significant toxicity. For the primary objective, PFS is defined as the length of time from randomization until documented disease progression (as assessed according to the Response Evaluation Criteria in Solid Tumors [RECIST; see Appendix C of the protocol]) or death on study treatment, whichever occurs earlier. Death on study treatment is defined as death from any cause within 30 days of the last dose of study treatment.

Critère d'inclusion

non-small cell lung cancer

Liens

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Kusajili – Centralise les essais cliniques mondiaux

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE IIIb TRIAL COMPARING BEVACIZUMAB THERAPY WITH OR WITHOUT ERLOTINIB AFTER COMPLETION OF CHEMOTHERAPY WITH BEVACIZUMAB FOR THE FIRST-LINE TREATMENT...