The aim of this clinical trial is to test whether the drug nelfinavir, which can increase the
effectiveness of radiotherapy, can be given safely at the same time as a full dose of
radiotherapy for lung cancer.
It is thought that one way that nelfinavir works is through causing changes in the blood
vessels within tumours. The status of tumour blood vessels and the blood flow through them
will be investigated during the trial using special imaging techniques. The dose of radiation
used in this trial is greater than that used in previous trials with nelfinavir in other
disease settings and the response of normal lung to the combination of nelfinavir plus
radiation is unknown. Therefore, a low dose of nelfinavir will be given to the first few
patients that participate and will be gradually increased in subsequent groups of patients
provided that no worrying side effects are identified. There is a single report of serious
side-effects in an AIDs patient who was treated with radiotherapy for lung cancer when he was
also taking nelfinavir. However, in this case nelfinavir was taken at a dose 3-fold higher
than the highest dose level to be tested in this trial. An important goal of this trial is to
select the optimum dose of nelfinavir to be used in combination with lung radiotherapy, that
can then be tested more extensively in future trials.
The radiotherapy treatment in this trial has been carefully designed to minimise the amount
of healthy lung that receives radiation. Some specialised imaging techniques will be used
during radiotherapy planning and delivery to help ensure that the lung cancer is targeted
very precisely by radiation and that normal lung is avoided as much as possible.
One effect of nelfinavir is to interfere with the function of a particular protein in cells
(called AKT). The degree to which this happens can be measured in cells from blood or tissue
samples. Therefore, another aim of the study is to investigate AKT and related proteins, to
check whether nelfinavir is having the predicted effect.