At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
Osimertinibdrug
Likely dose
Osimertinib 80 mgfrom 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 Phase IIa Clinical Trial to Evaluate the Safety and Efficacy of Osimertinib (AZD9291) in First-line Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC and Concomitant EGFR T790M Mutation at Time of Diagnosis
In Brief
A Phase 2 clinical trial evaluating Osimertinib for Non-Small Cell Lung Cancer. Completed, enrolled 22 participants across 7 sites.
Detailed Summary
The primary goal is to evaluate the efficacy of osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria. Safety and efficacy will also be measured.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesSpain
CollaboratorsAstraZeneca
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartSep 2016
Primary CompletionDec 2018
Study CompletionFeb 2020
TodayJul 2026
First PostedJul 22, 2016
Enrollment StartSep 2, 2016
Primary CompletionDec 1, 2018
Study CompletionFeb 14, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.9 years ago
Interventions
Osimertinibdrug
The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.