A multicentre single-arm phase II trial assessing the safety and efficacy of first-line osimertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR-mutant non-small cell lung cancer.

STEREO: Osimertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR mutant NSCLC

The trial explores the safety and efficacy of osimertinib treatment and locally ablative radiotherapy to all cancer sites, in patients with synchronous oligo-metastatic EGFR-mutant NSCLC. 

Trial Scheme

 trial scheme

 

Primary Endpoint: Rate of grade ≥2 pneumonitis, requiring medical treatment, observed any time during the first 18 months of follow-up from enrolment, in the primary-endpoint safety cohort. If safety is proven, efficacy will be hierarchically tested in terms of PFS according to RECIST v1.1, in the efficacy cohort.
Secondary Endpoints:

Overall survival

Pattern of disease progression

Distant progression-free survival

Objective response rate

Duration of response

Toxicity by CTCAE v5.0

Symptom-specific and global quality of life

Target Sample Size: 60 enrolled patients
Protocol Release Date: 26 April 2020
Trial Activation Date: 19 November 2021
   

Trial Organisation

Trial Chair: Matthias Guckenberger, Zürich, Switzerland
Trial Co-Chairs:

Egbert F. Smit, Amsterdam, the Netherlands

Cho Byoung Chul, Seoul, South Korea

Sponsor: ETOP IBCSG Partners
Coordinating Group: ETOP IBCSG Partners
Participating Group: SLCG
Participating Countries:   

Europe: Italy, the Netherlands, Poland, Spain, Sweden, and Switzerland

Asia: Singapore and South Korea

Registrations:

EudraCT number: 2020-004114-35

clinicaltrials.gov: NCT04908956


Contact

Robin Schweri (Trial Manager)

This email address is being protected from spambots. You need JavaScript enabled to view it.

 

ETOP IBCSG Partners Foundation

Effingerstrasse 33

3008 Bern, Switzerland