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Clinical Trials
On this page you will be able to see what clinical trials there are, what they are trying to achieve, and how to view them.
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.
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.
Name
Summary
Action
Now Recruiting Newly Diagnosed Patients
Neladalkib compared with Alectinib in Patients with Advanced ALK-positive NSCLC - the ALKAZAR Study.
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.
For Patients who have progessed on other TKIs
Neladalkib (NVL-655) for Patients with Advanced NSCLC and other Solid Tumours
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.
Evaluating Sigvotatug Vedotin Compared With Docetaxel
This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type of antibody drug conjugate or ADC and compares it with Docetaxel chemotherapy.
Shortened High-dose Palliative Radiotherapy for Lung Cancer (SHiP-Rt) Study
A Study to investigate the safety and efficacy of reducing the number of RT fractions and RT duration, compared to the current standard of care (36Gy in 12 fractions over 16 days), by using shortened hypofractionated accelerated palliative radiotherapy (30Gy in 6 alternate-day fractions),
Navigational Bronchoscopy For Ablations of Tumours In The Lung
A trial at the Royal Brompton into the use of robotic-controled brochoscopy to ablate tumours in the lung.
Immunotherapy or Targeted Therapy with or Without Stereotactic Radiosurgery for Patients with Brain Metastases from Non-small Cell Lung Cancer
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.
Sacituzumab Tirumotecan Versus Chemotherapy in Previously Treated Advanced Non-small Cell Lung Cancer (NSCLC) With a Genomic Alteration
This study compares chemotherapy with an antibody-drug conjugate (ADC) for patients who have progressed on TKIs. Report not expected until 2030 but currently recuiting.
Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors
The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab.
A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)
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).
A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer
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.
PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer
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.
TRIANA TRIAL. Molecular glues may solve a very specific—and very stubborn—problem: drug resistance. Lung tumors, especially non–small cell lung cancer (NSCLC), often adapt to targeted therapies, making once‑effective drugs stop working. Molecular glues offer a way around that by forcing cancer‑driving proteins into shapes or partnerships that lead to their destruction or reactivation of lost tumor‑suppressing functions.
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.
World's first lung cancer vaccine in trial for high risk patients.
£1.7 million for the world's first vaccine to prevent lung cancer.
Cancer Vaccines
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.
World-Wide Studies & Trials
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
Summary
Action
Clinicaltrials.gov
A USA governemnt site which is probably the first place to start a seach for a clinical trial.
European Clinical Trials Register
Allows you to search for protocol and results information on interventional clinical trials that have been approved in the EU.
Clinical Net
Clinical Net is a UK health-tech startup develoipiong a centralised clinical trials platform.
Artiificial Inteligence
Using AI can be a useful way to start searching for clinical trials.
View
Studies of Interest
Name
Summary
Action
A Summary of Vaccine Studies In The UK
This document summarises information on vaccine Studies going on throughout the UK
ALINA: Efficacy & Safety of Adjuvant Alectinib vs Chemotherapy in Patients
Efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ NSCLC
ALK Life Study - A Longitudinal Study
An ongoing study collecting data from patients globally.
CROWN Study Lorlatinib as 1st Line Treatment
Lorlatinib improved progression-free survival (PFS) and intracranial activity versus crizotinib in patients with previously untreated.