Thank you for registering your interest in this NSCLC trial. A member of the research team will be in touch soon to go through the study with you.
What is the study for?
The purpose of this study is to assess the safety and efficacy (how well it works) of the investigational treatment.
What's involved?
The study will be conducted in 3 parts (Part A, B, and C) with up to 182 patients. The study will initially take place at up to 6 clinical sites in Australia and may expand to other countries at a later stage of the trial.
You will only participate in 1 part of the study (either Part A, B, or C). Your doctor will tell you which part you are participating in and what your starting dose of the investigational treatment will be. All patients will receive the same dose of cemiplimab.
Study procedures will include:
- Medical and NSCLC History
- Medications
- Historical genetic status
- Physical exam (including height, weight, blood pressure, pulse, temperature, respiratory rate)
- Laboratory assessments
- Radiographic imaging and disease evaluation
- Blood and urine samples
- Tumor Tissue
- Pregnancy Tests
- CT/MRI Scans
- Electrocardiogram (ECG)
Additional tests: If you experience side effects during the study then your doctor may ask you to have additional tests such as additional blood draws.
You will be paid a flat rate per visit for this study. This is expected to cover for any reasonable travel, parking, meals and other expenses associated with the study visit.
Where can I find more information?
More information can be requested by contacting the research site to the right. Alternatively, the research team will be more than happy to answer any questions you may have when they call.
A description of this study will be available on publicly listed registers, www.anzctr.org.au and https://clinicaltrials.gov.
HREC approval: Bellberry Human research Ethics Committee