1. Risk and burden for patients
Patients in the first part of this study have cancer that is no longer responding to standard anticancer drug treatments.The phase 1 nature of this study means that the trial intervention may not have any additional benefit for patients who take part in the study.
The study itself carries a number of potential burdens:
* Study drug and radiotherapy:
Although the study drug safety effects have previously been assessed in NSCLC the side effects caused by the addition of radiotherapy is unconfirmed. These risks will be managed as much as possible by cautious dose escalation: as with all phase 1 studies, the data from each cohort will be reviewed by a safety review committee before deciding whether to increase the dose for subsequent cohorts.
Participants will be reviewed regularly by experienced clinicians while having the study treatment. Comprehensive assessments for safety will be carried out.
* Burden of frequent hospital visits and tests:
Participants in this study must attend hospital frequently, particularly at the start of the study, for safety reasons to check for any toxicity of the study treatment. Blood tests, clinical examination, urine tests, haematology, bio chemistry and lung function tests are part of the safety assessment. Additionally, for research purposes some participants may be asked to have additional blood taken, these will not be mandatory for entry into the study.
2. Recruitment
Participants will be offered information about this study by their clinical teams if they are considered to meet the entry criteria (with regard to advanced disease without therapeutic option, suitable performance status) and express interest in taking part in an experimental study. It will be made clear that the study is experimental in nature and that there will not necessarily be a therapeutic benefit from taking part in the study. It will also be made clear that, should patients decide not to take part their future care will not be affected. Patients will be given sufficient time and information to make an informed decision about entering the trial, all patients entering the trial will give written informed consent.
4\. Confidentiality
Patients will be linked to a unique identifier the code for which will be held on a password protected database held only by the study team. This study will run at the Royal Marsden Hospital Only. Research blood and tumour data will be analysed by a team at the Institute of cancer Research. Sample processing will take place using the trial ID only. No other patient identifiable information will be available on study samples. Investigators will have access to patient identifiable information on password protected NHS hospital notes and databases only.
5\. Conflict of Interest
Patients may be recruited to the study by those involved in their prior clinical care. The investigators do not expect conflict of interest between research and healthcare duties for a number of reasons: patients must give their full informed consent before entering the study, specifically regarding the unknown efficacy of the study drug. Those patients who do not continue in the study will maintain a relationship with the clinical team if required for symptom control. At the end of the study, patients will be able to access the results if they wish, through the Royal Marsden Website. They will also be sent a written summary of the results if they indicate this.
6\. Use of tissue samples in future research
If participants give their consent, any leftover blood or tissue samples which are not required for this study will be stored for future unspecified research in line with the human tissue act regulations. Access and use of samples for research purposes will require appropriate ethical approval. Future researchers will not be able to identify individual patients from their biobank data, demographic and clinical information will be available.
