* Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC
Research type
Research Study
Full title
A Phase 1/2 Study Targeting Acquired Resistance Mechanisms in Patients with EGFR Mutant Non-Small Cell Lung Cancer
IRAS ID
298127
Contact name
James Leigh
Contact email
Sponsor organisation
Blueprint Medicines Corporation
Eudract number
2020-005822-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, days
Research summary
Non-Small Cell Lung Cancer (NSCLC) is a group of lung cancers that are named for the kind of cells found in the cancer and how the cells look under a microscope. EGFR is a protein (a substance produced by the body) found on the surface of cells to which epidermal growth factor (EGF) binds. Mutations of this protein arise in response to treatment with currently approved Tyrosine Kinase Inhibitors (TKIs) and produce resistance and reduction in effectiveness to these treatments.
BLU-945 is a novel, orally available and selective inhibitor of Epidermal Growth Factor Receptor resistance mutations, developed for the express purpose of overcoming the resistance mutations that occur after use of prior EGFR Tyrosine Kinase Inhibitor. BLU-945 has demonstrated promising preclinical data that, when taken to the clinic, may address resistance to prior generation EGFR Tyrosine Kinase Inhibitors. It has the potential to address the unmet clinical need for patients with NSCLC.
This is a Phase 1/2, open-label, first-in-human study consisting of 2 phases. The main objective of this study is to determine the recommended dose of BLU-945 (Phase 1 or dose escalation) and to assess any potential anticancer activity and safety of BLU-945 at the recommended dose (Phase 2 or dose expansion). The expected enrollment period is approximately 12 months for escalation and 12 months for the expansion. It is anticipated that patients may receive treatment for an average of 12 months, and follow-up may be continued for 6 months. Thus, the expected duration of the study is approximately 42 months from enrolment of the first patient to completion of the last patient.
Approximately 28 sites globally (1 site in the UK) will take part in the study and up to 120 patients globally (4 patient in the UK) will be enrolled.
REC name
London - Westminster Research Ethics Committee
REC reference
21/FT/0141
Date of REC Opinion
19 Oct 2021
REC opinion
Further Information Favourable Opinion