At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 492 enrolled
Drug / intervention
AZD3759 +2 moredrug
Likely dose
AZD3759 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating AZD3759, Erlotinib, and 1 other intervention for Non-small Cell Lung Cancer and 2 related conditions. Completed, enrolled 492 participants across 58 sites in 4 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, Singapore, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartOct 2018
Primary CompletionJul 2022
TodayJul 2026
First PostedAug 31, 2018
Enrollment StartOct 29, 2018
Primary CompletionJul 12, 2022
TodayJul 1, 2026
Enrollment to primary: 3.7 yearsPosted 7.8 years ago
Interventions
AZD3759drug
AZD3759 200mg PO BID.
Erlotinibdrug
SoC EGFRTKI Erlotinib 150 mg PO Q.D
Gefitinibdrug
SoC EGFRTKI Gefitinib 250 mg PO Q.D