Non-small cell lung cancer (NSCLC), which is a type of epithelial lung cancer is prevalent in Japan. The absolute number of newly reported cases and deaths in men and women have increased over the years.

Building awareness about the trial is an important strategy for recruitment. It is important that not just patients with NSCLC but also clinicians and general practitioners and oncology clinics have information about the trial being conducted so that potential patients can be refereed during the enrolment period

This significant increase is represented in the demographic ageing population and among older adults who have been exposed to active and passive cigarette smoking. NSCLC is an aggressive form of cancer where treatment options depend on the stage of the cancer the patient is in. Many clinical trials are underway to improve treatment methods for NSCLC and recently 3H has lent an expert hand in facilitating the smooth initiation of a clinical trial in NSCLC. The clinical trial named ‘KISEKI’ is an initiative by a clinician and the first of its kind in Japan.

The use of EGFR as a targeted therapy for NSCLC: The investigational product which is used in this trial is an EGFR inhibitor. It is an epidermal growth factor receptor inhibitor which is used to slow down or inhibit tumour growth in NSCLC patients. The use of epidermal growth factor receptor (EGFR) inhibitors are part of a targeted therapy for NSCLC. These agents are most effective in patients with tumours which use an EGFR signalling pathway for propagation. EGFR inhibitors are present as first, second and third generation drugs with the third generation drugs being administered when the first and second generation drugs are not working well. Some of the currently used EGFR-inhibiting drugs include tyrosine kinase inhibitors (TKIs) like Erlotinib, and monoclonal antibodies like Cetuximab. Use of these EGFR inhibitors are coupled with chemotherapy or radiation therapy for greater results. At present EGFR inhibitors are used on patients who have a T790M mutation which has been confirmed on testing.

This clinical trial focusses on NSCLC patients who would be treated with EGFR inhibitors as a first line of defence even without the presence of a T790M mutation and also on those who cannot use third generation EGFR inhibitors for a second line therapy. Till recently EGFR inhibitors were only used for individuals who were T790M mutation positive and as a  second line therapy, but now with the EGFR inhibitor been approved for use as a first line of therapy, this trial intends to study it’s benefits and outcomes . The name ‘KISEKI’ has been selected to derive the meaning of ‘Miracle’ and it will remain as a ‘trajectory’ for the people who follow its use with hope for better cure and standard of living.

THE ROLE OF 3H IN KESEKI SUCESS

Selecting the Performing Site: Proper site identification is a key step towards recruitment. Having proper site identification can help with correct site selection to achieve the targeted recruitment figures of the clinical trial. 3H has been instrumental in providing an expect hand in site selection process in this trial at prominent hospitals which had the required infrastructure and patient pool to enable smooth initiation of the KISEKI trial. 3H was able to build on evidence based strategies. To help with keeping the costs low and achieve maximum performance levels, the right number of clinical trial sites were added without any additional sites which would have overburdened the cost.

Clinical trials which kick start successfully, have a great chance to succeed in recruitment within the timeline. Poor site selection can put an entire clinical trial behind schedule. This is why 3H has been very careful in the selection of right hospitals for this clinical trial.

Information Support: Information availability and a platform to make inquiries confidentially makes it easy for the public to make an informed decision to enrol or not in a clinical trial. 3H has provided assistance in coordinating inquiries from potential subjects and family members by using the latest technology to respond to respondents without any delays. Inquiry support is crucial for a clinical trial as it helps to build trust and confidence by removing any communication barriers. It helps to streamline potential subject identification through information collection to help in patient screening. 3H had two channels set up for easy public access, a public toll-free number to provide details of the KISEKI trial. In addition, information was posted on the signature ONCOLO website with a comprehensive landing page to collect potential subject details. Confidentiality of personal details of inquirers has been maintained.

Successful Awareness Campaign: Building awareness about the trial is an important strategy for recruitment. It is important that not just patients with NSCLC but also clinicians and general practitioners and oncology clinics have information about the trial being conducted so that potential patients can be refereed during the enrolment period, if they match the eligibility criteria for screening with subject consent. 3H’s ONCOLO website has been a great tool for awareness building both about the disease condition and the available clinical trials.

3H has the expertise in optimising clinical trials to suit the modern needs of clinical trial conduct. Using the latest technology and evidence based strategies 3H has made clinical trials to work within your budget while maintaining GCP standards to achieve ethics, security, confidentiality by using tested strategies to put your clinical trial in the right direction.

To know more about 3H Lung Cancer Study Campaign, please contact imran@3h-ms.co.jp