A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib

Conditions

• EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Osimertinib — DRUG
  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.

Study Details

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

Key Dates

Start date

May 30, 2018

Status verified

Sep 2024

Primary completion

Sep 19, 2023

Completion

Sep 19, 2023

Study Design

Enrollment

154 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Osimertinib
  An oral, potent, selective, irreversible inhibitor of both EGFR-tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer

Primary Outcome Measure

Proportion of Patients With a Given Tumour Genetic and Proteomic Marker at the Point of Disease Progression [ Time Frame: Genetic and proteomic markers were assessed at baseline and progression (up to 5 years after baseline) ]

Locations (3)

Find similar trials in Athens, GA