73841937NSC2001
Research type
Research Study
Full title
A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer(NSCLC)
IRAS ID
271843
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen Cilag International NV
Eudract number
2019-003106-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Around 10-15% patients with lung cancer have a faulty gene in their cancer known as an Epidermal Growth Factor Receptor (EGFR) mutation. This faulty gene tells the cancer cells to grow and divide. Doctors have known this for many years and several drugs are available routinely in the clinic to block this faulty gene. These drugs result in shrinkage of the cancer and prolonged survival for the majority of patients that receive it (providing they have an EGFR mutation). However, over time cancer cells become resistant to this treatment and it no longer works, typically after around 12 months. Often this happens due to a new mutation’ in the EGFR gene (which results in a change in shape of the EGFR receptor so the drug can no longer bind. The experimental drug in this study, known as YH25448, has been specifically designed to target the EGFR gene more effectively, particularly after patients have become resistance to prior treatment with an older EGFR inhibitor. Another advantage of YH25448 is the ability for it to get into the brain. Unfortunately it is common for lung cancer to spread to the brain. Whilst most drugs cannot easily get into the brain to treat, YH25448 has been proven in animal models that it has the capability to do this. In mice, tumour growth in the brain was halted with the drug and the mice survived for longer. Activity was also shown in the brain of mice and rats. This current study will test the benefit of YH25448 in patients with advanced, non-small cell lung cancer that has spread, have been diagnosed with a EGFR mutation and who have had standard of care treatment which has not worked. About 30 patients will take part in this worldwide study. The purpose of this study is to see if YH25448 is safe and useful for treating patients. The amount of YH25448 that is in the blood after the drug has been taken will also be studied. There are 4 parts to this study; Part A, B and C are testing different doses starting with a dose considered to be safe based on animals and tests conducted in blood from volunteers. Part D is to look at two doses of YH25448 only. This part is to compare the levels of drug in the blood after dosing in different races, as different amounts have been seen so far. This is important when deciding a dose that will be safe, tolerable and effective to races outside of Korea, which is where much of the data has been collected to date. All patients will remain on YH25448 whilst it is seen to be of clinical benefit to them and will attend regular clinic visits. The UK will participate in Part D only.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0332
Date of REC Opinion
26 Nov 2019
REC opinion
Further Information Favourable Opinion