No EGFR Activating Mutation Clinical Trial
Official title:
Could Positon Emission Tomography With Radiolabelled 3'-Deoxy-3'-(18)F-Fluoro-L-Thymidine be a Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patients ?
In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances
have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine
kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as
erlotinib.
This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST
criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.
Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and
18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has
identified early responding patients and with better progression-free survival in erlotinib
first line and in the second or third line.
To date, none medico-economic study has been conducted to determine if this strategy will be
cost-effective.
The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and
18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib
(second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to
the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8
of erlotinib treatment.
A health economics ancillary study will be achieved. Indeed, recent therapeutic
improvements, in particular targeted therapies in NSCLC, have improved quality of life and
life expectancy, but have also induce an important increase of the health costs. According
to studies, the mean cost of the treatments of NSCLC has been increased by a factor 3 during
the 10 last years. More efficient strategies that would permit to stop early with objective
endpoints, expensive therapies is a main achievement in thoracic oncology.
The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders
and replace another treatment before a deterioration in their physical status, 2) reduce the
risk of side effects and costs of unnecessary treatment and 3) to propose a customization
treatment after the first line therapy.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label