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Strona główna / Informacje / Badania kliniczne

Badania kliniczne

Na tej stronie dowiesz się, czym są badania kliniczne, jaki jest ich cel i jak możesz się w nie zaangażować.

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.

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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.

Clinical Trials in UK

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.

Nazwa

Streszczenie

Działanie

NVL-665 u pacjentów z zaawansowanym ALK-dodatnim rakiem płuca niedrobnokomórkowego

​A new Phase 3 trial is open  at several centres comparing Neladalkib (formerly NVL-655) with Alectinib as a first line treatment for newly diagnosed patients..  The report is not expected until 2030.

NVL-665 u pacjentów z zaawansowanym ALK-dodatnim rakiem płuca niedrobnokomórkowego

A study of NVL-655  in patients who have progressed on other TKis and patients who have not received a prior TKI. (ALKOVE-1).

A preliminary report is expected in October 2025 and a full report  before the end of the year.

Although the study has closed, patients may still be able to access the drug under the Expanded Access Programme.

Bronchoskopia nawigacyjna do ablacji guzów płuc

A trial at the Royal Brompton into the use of robotic-controled brochoscopy to ablate tumours in the lung.

Immunoterapia lub terapia celowana z radiochirurgią stereotaktyczną lub bez niej u pacjentów z przerzutami do mózgu z niedrobnokomórkowego raka płuc

The primary objective of the study is to assess the efficacy  of the combination of standard systemic treatment plus radiotherapy to the brain versus standard systemic treatment alone. The study will report in 2026.

Bronchoskopia nawigacyjna do ablacji guzów płuc

The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab.

Bronchoskopia nawigacyjna do ablacji guzów płuc

This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC).

Bronchoskopia nawigacyjna do ablacji guzów płuc

UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.

Bronchoskopia nawigacyjna do ablacji guzów płuc

Patients have received at least one TKI and platinum-based combination therapy  or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting.

Bronchoskopia nawigacyjna do ablacji guzów płuc

TRI-611 is a novel molecular glue degrader developed by TRIANA Biomedicines, specifically designed to target the ALK receptor tyrosine kinase. 

A Phase 1/2 trial opened in the USA in March 2026 and it is expect to become available in the UK.

Bronchoskopia nawigacyjna do ablacji guzów płuc

£1.7 million for the world's first vaccine to prevent lung cancer.

Bronchoskopia nawigacyjna do ablacji guzów płuc

Therapeutic cancer vaccines aim to help the body’s immune system recognise the antigens found in cancer cells and to attack and destroy the cancer cells that have them.  

Światowe badania i szlaki

Unfortunately, there is not a single registry of all clinical trials that are being conducted throughout the world.  Below, are several sources of information on clinical trials.

Name

Streszczenie

Action

Clinicaltrials.gov

Arkusz kalkulacyjny Google zawierający informacje o bieżących badaniach klinicznych.

European Clinical Trials Register

Arkusz kalkulacyjny Google zawierający informacje o bieżących badaniach klinicznych.

ALK+ Trials/Studies

Arkusz kalkulacyjny Google zawierający informacje o bieżących badaniach klinicznych.

Clinical Net

Arkusz kalkulacyjny Google zawierający informacje o bieżących badaniach klinicznych.

ALK Positive Inc

Arkusz kalkulacyjny Google zawierający informacje o bieżących badaniach klinicznych.

Cancer Research UK

Arkusz kalkulacyjny Google zawierający informacje o bieżących badaniach klinicznych.

Artiificial Inteligence

Arkusz kalkulacyjny Google zawierający informacje o bieżących badaniach klinicznych.

Studies of Interest

Nazwa

Summary

Action

Podsumowanie badań nad szczepionkami w Wielkiej Brytanii

This document summarises information on vaccine Studies going on throughout the UK

ALINA: Skuteczność i bezpieczeństwo leczenia adiuwantowego Alectinibem w porównaniu z chemioterapią u pacjentów

Efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ NSCLC

Plain English Report

ALK Life Study - badanie podłużne

An ongoing  study collecting data from patients globally.

Badanie CROWN Lorlatinib jako leczenie pierwszej linii

Lorlatinib improved progression-free survival (PFS) and intracranial activity versus crizotinib in patients with previously untreated.

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ALK Positive Lung Cancer (UK) is committed to producing reliable, accurate and up-to-date content reflecting the best available research evidence and best clinical practice. We aim to provide unbiased information free from any commercial conflicts of interest.

ALK Positive Lung Cancer (UK) is a registered charity in England and Wales ((1181171) and Scotland (SC053692).  The registered office is at 1 Ethley Drive, Raglan, Monmouthshire, NP15 2FD.

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