Trial intelligence / Profile preview

Osimertinib +/- SRS in EGFR+ NSCLC with Brain Mets

NCT03769103Phase 2

Key facts

Status: Active, not recruiting
Start: Mar 2019
Primary completion: Apr 2025
Countries: 1
Sponsor: BC Cancer
Modality: Small Molecules

Drugs: osimertinib
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, randomised, open-label trial of osimertinib in non-small cell lung cancer (NSCLC) (2 arms), sponsored by BC Cancer. Primary endpoint: Intracranial progression free survival at 1 year. Started Mar 2019; status: active, not recruiting.

Design

2 arms

Study design: RandomizedOpen-label

SRS + Osimertinib
Stereotactic radiosurgery followed by daily Osimertinib
Osimertinib alone
Daily Osimertinib monotherapy

Who it enrols

Patients with treatment-naïve EGFR mutation-positive NSCLC and asymptomatic or minimally symptomatic brain metastases.

Endpoints

Primary

Intracranial progression free survival1 year

Secondary

Intracranial overall response rate2 years
Time to whole brain radiotherapy2 years
Time to stereotactic radiosurgery2 years
Rate of radionecrosis2 years
Overall survival2 years
Time to distant progression2 years
Quality of life2 years
Neurocognitive function2 years

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