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

NCT03653546 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 492

Last updated 2025-09-10

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Alpha Biopharma (Jiangsu) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yilong Wu, M.D. · Guangdong Provincial People's Hospital

  • Myung-Ju Ahn, M.D. · Samsung Medical Center, Sungkyunkwan University School of Medicine

  • Jie Wang, M.D. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Qing Zhou, M.D. · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2022-07-12
Completion
2022-07-12

Countries

  • China
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653546 on ClinicalTrials.gov