NSCLC Clinical Trial
Official title:
Randomized, Open-label, Controlled Multicenter Study to Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in Chinese NSCLC Patients Harbouring Activating EGFR Mutations(Artemis)
This is a randomized, open-label, controlled, multicenter, Phase III study. Patients will be randomly assigned to treatment group (1:1) through a dynamic randomization process with use of the following stratification factors: sex (female/male), disease stage (stage IIIb vs. stage IV vs. recurrence), and EGFR gene mutation (exon 19 deletion vs. exon 21 L858R).
This is a randomized, open-label, controlled, multicenter, Phase III study. Patients will be
randomly assigned to treatment group (1:1) through a dynamic randomization process with use
of the following stratification factors: sex (female/male), disease stage (stage IIIb vs.
stage IV vs. recurrence), and EGFR gene mutation (exon 19 deletion vs. exon 21 L858R).
An independent review committee (IRC) will be used to determine the response based study
endpoints. IRC membership and procedures will be detailed in an IRC charter.
A data safety monitoring board (DSMB) will be used in this study. DSMB is an independent body
and will be responsible for reviewing safety data of the study. DSMB membership and
procedures will be detailed in a separate DSMB document.
Information regarding the nature and the duration of subsequent treatment will be collected.
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|---|---|---|---|
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