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ক্লিনিকাল ট্রায়াল

এই পৃষ্ঠায় আপনি ক্লিনিকাল ট্রায়ালগুলি কী, তারা কী অর্জন করার চেষ্টা করছে এবং কীভাবে এতে জড়িত হতে হবে তা দেখতে সক্ষম হবেন।

There are probably thousands of studies and trials taking place throughout the world into ALK-positive lung cancer. Many will be in the laboratory. All add to scientific knowledge.

A relatively small number of studies and trials will involve a drug being taken by a patient. Every clinical trial will have strict inclusion and exclusion criteria which means that they may not be available to some patients. Some clinical trials will be ALK+ specific while others will be open to non-ALK+ patients.

Because of inclusion and exclusion criteria, the results of clinical trials may not be replicated in the real world.

A Guide to understanding clinical trials

This guide will help you gain a general understanding of clinical trial data. It will help you feel more informed as you make decisions about your care and talk to your care providers about treatment options.

Nuvalent Inc

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Waterfall Plot Explained

This plot shows how each person in a trial responded to the drug in terms of tumour shrinkage. It also shows the depth of response.

Dr Rishabh Jain

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Hazard Ratio (HR)

This is a measure of the risk of an event happening in a treatment under trial compared with a contol treatment. An HR of 1 would mean that there is no difference between the two treatments. A HR of less than 1 means that there is less risk of the event happening in the treatment under trial than in the control treatment and an HR above 1 means the risk is greater. The lower the HR, the better the treatment under trial is at preventing a negative event from happening.

For example, in the CROWN trial comparing Lorlatinib with Crizotinib, the HR for disease progression or death was 0.19. This means that there is an 81% less risk of death or progression with Lorlatinib than with Crizotinib at any given time during follow-up, This is a very low HR and won't be seen in many trials.

Censoring

Some patients will leave a study before experiencing the event being measured, e.g. progression. Patients may drop out of a study for various reasons, including volunary withdraw, illness not related to the study. These censored events are marked with a small vertical tick on the curve and the patients are not included in the alalysisw for the event being measured.

The number of patients remaining in the study is shown at each time interval at the bottom of the chart.

Kaplan-Meier Curve - CROWN Study of Lorlatinib v Crizotinib

On the chart, it can be seen that there are very few ticks before month 80, when 62 patients remained in the Lorlatinib arm. After month 80, there are a large number of ticks and the number of patients in the trial drops dramatically. This is not unusual at the end of a long study and, in this curve, means that the confidence level falls after month 80 due to the small numbers of patients remaining in the study

Phase I studies primarily assess the safety of a drug. They can be the very first time the drug has been administered to humans or it can be an approved drug that is being tested in a different type of cancer. A relatively small number of patients may be included at this stage. This initial phase of testing can last for several years because the trial design slowly increases the drug dose to identify the side effects before they are severe. The study will be single-arm and will determine how the drug(s) are absorbed, metabolized, and excreted.

Phase II studies primarily assess the efficacy of a drug. This second phase of testing can last several years. Some phase II studies may also be single arm but others may be randomized where one group of patients receives the experimental drug while a second “control” group receives a standard treatment. This allows investigators to provide comparative information about the relative safety and effectiveness of the new drug.

Phase III studies are typically randomized studies with many hundreds of patients that can last many years. In the end, the information provides a more thorough understanding of the effectiveness of the drug, the benefits, and the range of possible adverse reactions.

Before a drug can be used in the UK, it must receive a marketing authorisation (product licence) from The Medicines and Healthcare products Regulatory Agency confirming that it meets standards of quality, safety, and efficacy.

Before a drug can be prescribed in the NHS, it must be approved by the National Institute for Health and Care Excellence (NICE) as being cost-effective. Scotland has a similar regulator.

Because targeted therapies can be very efective for ALK+ patients, newly diagnosed patients would not usually seek clinical trials until they had exhausted standard treatments. An exception might be the Neladalkib/Alectinib trial referred to below.

যুক্তরাজ্যে ক্লিনিকাল ট্রায়াল

Below are the clinical trials that we believe are currently available in the UK for ALK-positive patients and the detailed trial documents for each can be viewed. Interpreting inclusion and exclusion criteria requires medical knowledge and patients should consult their oncologists to establish whether or not they might be eligible for a trial. The trial information lists the location of hospitals that are participating in the trial.

We endeavour to keep information current but changes may occur of which we are not aware, e.g. recruitment to a trial may close or a hospital may cease participating. Please tell us if you become aware of changes that we need to make.

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