SPECTAlung: improving clinical trial access for patients with thoracic tumours
Dr Jessica Menis - EORTC, Brussels, Belgium
Dr Benjamin Besse - Institut Gustave Roussy, Villejuif, France
JM: Patients are screened in 18 sites in 15 countries all around Europe. Patients are selected based on the main inclusion criteria which is a diagnosis of lung cancer, malignant pleural mesothelioma of malignancy, any stage at any time of their treatment phase. The requirement is availability of tumour tissue which is collected and centralised at Gustave Roussy Cancer campus where the DNA extraction and the quality control will be performed. Thereafter the DNA will be sent to 14MG which is based in Cambridge in the UK.
What are the study objectives?
JM: The objective is to data mine the molecular profile of the tumours of these patients and thereafter, if possible, to offer them the participation to a downstream clinical trial.
What methods will be used?
JM: The method is next generation sequencing, so a panel of about 360-400 genes will be the ones tested for all these patients.
How will you handle this information?
JM: All the information will be centralised so that it will be collected through electronic that are then centralised at the EORTC headquarters in Brussels.
What are the study’s primary and secondary endpoints?
JM: The main goal is ideally to screen these patients and to offer them a targeted treatment based on their molecular profile. And, of course, to assess the quality of the testing performed.
What is the status of the study?
JM: The study has been activated in two countries, Italy and Slovenia, and so far we have eight patients enrolled.
How many patients are you hoping to enrol?
JM: 500 for the first year and 500 - 1,000 for the following years.
What other logistics did you have to consider in the study?
JM: Basically it’s important that the analysis is performed centrally so that the quality assurance is centrally done in Gustave Roussy and that the testing is performed by 14MG which is a spin-off of the Sanger Institute so the quality of the analysis is ensured likewise.
BB: SPECTA is a programme that has five branches, one of them being for patients with any thoracic malignancies. The idea came from lung cancer; today we treat roughly 15% of the patients in the daily practice based on the molecular profile, mainly EGFR-ALK. But we know that much more patients could be potentially treated based on the molecular profile but a very small number of patients bear a molecular abnormality. So when, as a treating physician, I have a new trial I have to open one trial for two or three patients per year. The goal of SPECTA is to have one screening per all, meaning I screen my patient with one large molecular portrait and based on that my patient will have… I would have a clear figure on what is the molecular abnormality that I can target and then I will put my patient into a clinical trial. But I will not screen each patient in each clinical trial; that is what I have to do today.
What is the concept behind SPECTAlung?
BB: The concept is one molecular portrait for all the patients and the idea is not to screen each patient in each trial but have one screening and then each clinical trial is plugged into SPECTAlung. So it saves time and mostly it saves tissue because in thoracic malignancies usually we have very small biopsies so we cannot screen for a lot of different trials.
Could you comment on the setting up of the project?
BB: It’s very ambitious and it’s quite expensive so it’s a huge effort from EORTC and it’s a trial that is run in collaboration with ETOP but it’s a huge effort, a financial effort, to support that. Today it’s only charity that allowed us to start this programme.
What does SPECTAlung hope to achieve?
BB: First, I hope that patients will be treated in a better way and that they will receive more targeted treatment. Then we will have a quite good assessment of what is the molecular epidemiology of thoracic malignancies in Europe because in four to five years we should have at least 4,000 molecular profiles of patients with thoracic malignancies.