CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
Osimertinibdrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Histologically confirmed locally advanced or metastatic NSCLC (TNM M1 stage)
  • ✓EGFR deletion or sensitizing mutation (from tumor biopsy or plasma)
  • ✓Measurable or evaluable disease per RECIST 1.1
  • ✓WHO performance status 0–1
Key exclusion· 12
  • ✕EGFR exon 20 insertion
  • ✕Locally advanced NSCLC candidate for curative radical surgery or chemoradiation
  • ✕Prior EGFR TKI treatment for lung cancer (any setting including adjuvant)
  • ✕Prior systemic chemotherapy or immunotherapy for advanced/metastatic NSCLC

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03239340
NCT03239340Phase 2Completed
CompareCT.gov

A Multicentre, Open-label, Single-arm, Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib

AstraZeneca·interventional·Posted Aug 4, 2017·Updated Oct 21, 2024

In Brief

A Phase 2 clinical trial evaluating Osimertinib for EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Completed, enrolled 154 participants across 26 sites in 5 countries.

Detailed Summary

A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
CountriesItaly, Malaysia, South Korea, Spain, United States
CollaboratorsParexel

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 4, 2017
Enrollment StartMay 30, 2018
Primary CompletionSep 19, 2023
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.9 years ago

Interventions

Osimertinibdrug

Osimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR-tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer with a significant selectivity margin over wild type EGFR.