A phase 3, open-label, randomized, multi-center study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line treatment for patients with locally advanced or metastatic Non-Small Cell lung cancer harboring epidermal growth factor receptor Exon 20 insertion mutation

Description

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).

Resources and Links

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT05668988 Opens a new window