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

Sponsor
Alpha Biopharma (Jiangsu) Co., Ltd.
Study ID
NCT03653546
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD3759 — DRUG
    AZD3759 200mg PO BID.
  • Erlotinib — DRUG
    SoC EGFRTKI Erlotinib 150 mg PO Q.D
  • Gefitinib — DRUG
    SoC EGFRTKI Gefitinib 250 mg PO Q.D

Study Details

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

Key Dates

First listed
Aug 31, 2018
Start date
Oct 29, 2018
Status verified
Sep 2025
Primary completion
Jul 12, 2022
Completion
Jul 12, 2022

Study Design

Enrollment
492 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD3759 Group
    AZD3759 group will receive a 200 mg twice daily dose of AZD3759
  • Active Comparator: Erlotinib or Gefitinib Group
    SoC EGFR-TKI Erlotinib or Gefitinib Group will get EGFRTKI Erlotinib 150 mg or Gefitinib 250 mg PO Q.D

Primary Outcome Measure

PFS assessed by Blinded Independent Central Radiological [ Time Frame: 48 months ]

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