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کلینیکل ٹرائلز

اس صفحہ پر آپ یہ دیکھ سکیں گے کہ کلینیکل ٹرائلز کیا ہیں، وہ کیا حاصل کرنے کی کوشش کر رہے ہیں، اور ان میں کیسے شامل ہونا ہے۔

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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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 also 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 are randomized trials 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.

برطانیہ میں کلینیکل ٹرائلز

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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اعلی درجے کی ALK- مثبت NSCLC والے مریضوں میں NVL-665

NVL-655 کا مطالعہ ان مریضوں میں جنہوں نے دوسرے TKis پر ترقی کی ہے اور ایسے مریض جنہوں نے پہلے TKI حاصل نہیں کیا تھا۔ (الکووۃ-1)

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اعلی درجے کی ALK- مثبت NSCLC والے مریضوں میں NVL-665

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