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Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO)

NCT04908956 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-06-28

No results posted yet for this study

Summary

STEREO is single-arm phase II study, which aims to evaluate the safety and efficacy of osimertinib combined with early locally ablative radiotherapy of all cancer sites in patients with synchronous oligo-metastatic (primary tumour and maximum 5 metastases) EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC. Eradication of all macroscopic cancer sites at the time of primary diagnosis by combined modality treatment is expected to decrease the risk of resistance development with only microscopic disease potentially remaining. This will result in an improvement of PFS and OS without added high-grade toxicity.

Conditions

  • NSCLC Stage IV
  • EGFR Gene Mutation

Interventions

DRUG

Osimertinib

Osimertinib is a Tyrosine Kinase Inhibitor (TKI). It is an irreversible inhibitor of Epidermal Growth Factor Receptors (EGFRs) harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M. The appropriate number of osimertinib tablets (80 mg or 40 mg if the dose is reduced due to toxicity) will be provided to patients to be self-administered at home.

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

SBRT will be delivered using risk-adapted SBRT with a maximum of 5 SBRT fractions.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Matthias Guckenberger, MD-PhD · University Hospital, Zürich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2023-10-31
Completion
2024-02-29

Countries

  • Italy
  • Netherlands
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
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 NCT04908956 on ClinicalTrials.gov