First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients With Central Nervous System Metastases

Summary

Participation Requirements

Description

This is a Phase II/III randomized, open-label, multicenter study to compare the efficacy and safety of first line single-agent AZD3759 vs. Erlotinib or Gefitinib treatment in patients with advanced NSCLC with CNS metastases. Eligible patients with documented EGFR mutation+ (L858R and/or Exon 19Del) ...

This is a Phase II/III randomized, open-label, multicenter study to compare the efficacy and safety of first line single-agent AZD3759 vs. Erlotinib or Gefitinib treatment in patients with advanced NSCLC with CNS metastases. Eligible patients with documented EGFR mutation+ (L858R and/or Exon 19Del) TKI-naïve advanced NSCLC and documented intracranial disease will be enrolled. Primary Objective: The primary objective of this study is to determine if administration of single agent AZD3759 compared to Standard of Care (SoC) EGFR-TKI as first-line therapy results in a significant increase in Progression Free Survival (PFS) in the study patient population by Blinded Independent Central Radiological(BICR) review. Secondary Objectives: Key secondary objective for this study is to determine if AZD3759 vs. SoC EGFR TKI administration demonstrates additional benefit in terms of safety, Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), and overall PFS using modified RECIST 1.1 criteria by investigator assessment. Additional secondary objectives include assessment of Health Related Quality of Life (HRQoL), neurological function, and Overall Survival (OS).

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