Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS)
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a single arm, open label, multicentric proof-of-concept, phase II study in patients
with EGFR-mutated non-small-cell lung cancer (NSCLC) with acquired TKI resistance who are
"unknown" for EGFR T790M status due to non-informative or unfeasible tumor rebiopsy, and a
negative finding for EGFR T790M in a standard plasma genotyping assay. All patients will
receive osimertinib as continuous oral treatment for one cycle (28 days). Patients who
demonstrate a metabolic response by FDG-PET scanning (to be conducted between day 15 and day
28 of cycle 1) will continue treatment until clinical or radiological progression.
Osimertinib treatment will be terminated in patients not experiencing a metabolic response.
Primary objective:
To study the rate of early metabolic responses to osimertinib in patients with EGFR-mutated
NSCLC and acquired TKI resistance who are "unknown" for EGFR T790M status due to
non-informative or unfeasible tumor rebiopsy, and a negative finding for EGFR T790M in a
standard plasma genotyping assay.