TARGET
Research type
Research Study
Full title
An Open-label, Single-arm, Phase II, Multinational, Multicentre Study to Assess the Efficacy and Safety of 5 Years of Osimertinib in Participants with Epidermal Growth Factor ReceptorMutation-Positive Stage II-IIIB Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (TARGET)
IRAS ID
1007138
Contact name
Agathe Cabarrot
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-003024-33
Clinicaltrials.gov Identifier
Research summary
Lung cancer is one of the most common and serious types of cancer, it mainly affects older people and is rare in those under 40.
Current therapies include surgery, radiotherapy, chemotherapy and targeted therapies.
Outcomes vary depending on how advanced the cancer is at diagnosis but on average 2 in 5 people live for at least a year following diagnosis while 1 in 10 live for at least 10 years.
The aim of this clinical research study is to learn more about osimertinib in the treatment of Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIB Non-small Cell Lung cancer (EGFRm NSCLC, or EGFRm lung cancer) and to better understand EGFRm lung cancer and associated health problems.
Osimertinib, is a tablet to be taken by mouth that has been approved as a therapy in addition to surgery for EGFRm lung cancer.
After surgery, some participants may also receive additional chemotherapy treatment, as decided by their study doctor but this is not part of the study.
Osimertinib has previously been tested in research studies in participants with EGFRm lung cancer and it was shown that participants taking it for up to 3 years had a reduction in the chance of the return of their cancer, with manageable side effects.
Osimertinib has been approved in the United States by the Food and Drug Administration since 2015, and in December of 2020 it was approved for use for up to 3 years after surgery for patients with EGFRm lung cancers.
The untested part of the study is the use of osimertinib in participants with EGFRm lung cancers for up to 5 years after surgery.This study will be conducted in approximately 11 countries at around 60 sites, approximately 682 patients will be screened with a target enrollment of 180.
AstraZeneca AB is the Sponsor of this study.
REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0333
Date of REC Opinion
12 Sep 2023
REC opinion
Further Information Favourable Opinion