Last updated on May 2019

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

Brief description of study

Primary Hypothesis The first-line treatment with single agent AZD3759 results in superior Progression Free Survival (PFS) compared to Standard of Care (SoC) Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKI), in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Central Nervous System (CNS) metastasis

Secondary Hypothesis The safety profile of AZD3759 is comparable to EGFR TKI first-line treatment in patients with advanced NSCLC with CNS metastasis.

Detailed Study 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) TKI-nave 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).

Clinical Study Identifier: NCT03653546

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