NCT03653546

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

A Randomized, Open-label, Controlled, Multi-Center Phase II/III Study to Assess the Efficacy and Safety of AZD3759 vs. a Standard of Care EGFR TKI, as First Line Treatment to EGFR Mutation Positive Advanced NSCLC With CNS Metastases

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 492 (actual)
• Sponsor: Alpha Biopharma (Jiangsu) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 EGFR mutation positive non-small cell lung cancer (NSCLC) with Central Nervous System (CNS) metastasis

Detailed 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 EGFR mutation positive 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.

Conditions

• Non-small Cell Lung Cancer
• EGFR Gene Mutation
• Brain Metastases

Interventions

Type	Name	Description
DRUG	AZD3759	AZD3759 200mg PO BID.
DRUG	Erlotinib	SoC EGFRTKI Erlotinib 150 mg PO Q.D
DRUG	Gefitinib	SoC EGFRTKI Gefitinib 250 mg PO Q.D

Timeline

• Start date: 2018-10-29
• Primary completion: 2022-07-12
• Completion: 2022-07-12
• First posted: 2018-08-31
• Last updated: 2025-09-10

Locations

58 sites across 4 countries: China, Singapore, South Korea, Taiwan