Clinical trial

Uncommon EGFR Mutations: International Case Series on Efficacy of Osimertinib in Real-life Practice in First Line Setting

NCT05421936

Name

UNICORN_226_13

Description

This is a multi-center, retrospective study of ucEGFRmut (exon 20 insertions excluded) metastatic NSCLC osimertinib-treated as first EGFR inhibitor. RECIST and RANO-BM brain objective response rate (ORR) were evaluated by investigators. mPFS, mOS and mDOR were calculated from osimertinib initiation. Mutations found at resistance were collected.

Trial arms

Trial start

2020-09-27

Estimated PCD

2024-09-01

Trial end

2024-09-01

Treatment

Osimertinib

Treatment as the first EGFR-TKI

Size

100

Primary endpoint

Progression free survival

From date of osimertinib initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Overall survival

From date of osimertinib initiation until date of death from any cause, assessed up to 100 months

Eligibility criteria

Inclusion Criteria: 1. Age ≥ 18 years 2. NSCLC by histologic or cytologic diagnosis 3. Stage IV or stage III not amendable to curative treatment (i.e., advanced disease) 4. Uncommon mutation of EGFR (exon 20 insertion excluded) 5. Treated with osimertinib for advanced disease as first TKI 6. Osimertinib initiated not later than end of January 2021 Exclusion criteria: 1. Lack of any follow-up data 2. Lack of consent for data collection or ethics committee approval for the waiver of informed consent (i.e. for deceased patients)

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-11-22

1 organization

1 drug

4 indications

Organization

Drug

Indication

Indication

Indication

Indication