REZILIENT2
Research type
Research Study
Full title
An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations
IRAS ID
1008132
Contact name
Jennifer Hodge
Contact email
Sponsor organisation
Taiho Oncology, Inc.
Research summary
The purpose of this clinical research study is to see how a new medication called zipalertinib works to treat this kind of lung cancer. We would like to find out if zipalertinib can help to shrink the size of the cancer, or postpone the growth or further spread of the tumour(s).
Approximately 72 sites will enrol around 160 participants in this study. Participants will be enrolled into one of four cohorts depending on their specific tumour types and previously received treatments. The study consists of a screening period, a treatment period and a follow-up period. Participants will be required to visit the site approximately once every 3 weeks while they are receiving treatment. Assessments such as physical examinations, vital signs, blood and urine collect, eye examination, electrocardiogram, imaging scans and questionnaires will be performed. For some participants there is an option to provide an cerebrospinal fluid sample, but this is optional for the participants. Zipalertinib is taken as a pill, twice a day. After treatment is completed the patients will be followed up every 3 months during the follow-up period.
Participants will be asked to avoid natural sunlight or artificial light (sunbeds), wear protective clothing, lip-balm and sunscreen when outside, during their treatment period as the study medication may cause their skin to be more sensitive to UV light.
Participants may receive the study treatment as long as the study is ongoing, providing that their cancer does not get worse, they do not have medically unacceptable side effects, and their study doctor determines their condition to be appropriate for the study.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/LO/0689
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion