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Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC

NCT03769103 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-31

No results posted yet for this study

Summary

This open-label, multicenter, randomized phase II study will evaluate the usage of osimertinib alone for brain metastases compared to SRS and osimertinib in patients with newly diagnosed, treatment naiive EGFR positive lung cancer.

Conditions

Interventions

DRUG

Osimertinib

Daily oral osimertinib

RADIATION

Stereotactic radiotherapy

1-5 fractions of stereotactic radiotherapy

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Shilo V Lefresne, MD, FRCPC · BC Cancer, Vancouver Centre

  • Cheryl Ho, MD, FRCPC · BC Cancer, Vancouver Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769103 on ClinicalTrials.gov