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

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT04908956
Phase
PHASE2
Status
Terminated

Conditions

  • EGFR Gene Mutation
  • NSCLC Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    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.
  • Stereotactic Body Radiation Therapy (SBRT) — RADIATION
    SBRT will be delivered using risk-adapted SBRT with a maximum of 5 SBRT fractions.

Study Details

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.

Key Dates

Start date
Aug 4, 2022
Status verified
Jun 2024
Primary completion
Oct 31, 2023
Completion
Feb 29, 2024

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib & SBRT
    Osimertinib 80mg once daily p.o., until progression or unacceptable toxicity \& locally ablative radiotherapy (SBRT) to the primary tumour and to all metastatic sites.

Primary Outcome Measure

Safety of first-line EGFR-targeting osimertinib and SBRT to the primary tumour and all metastases [ Time Frame: Rate of grade ≥2 pneumonitis, requiring medical treatment, any time during the first 18 months on trial follow-up ]

Related Studies