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Home / Information / Clinical Trials

Clinical Trials

On this page you will be able to see what clinical trials are, what they are trying to achieve, and how to get involved in them.

Clinical Trials in UK

Name

Summary

Action

Every clinical trial will have strict inclusion and exclusion criteria which means that they may not available to some patients.

Some clinical trials will be ALK+ specific while others will be open to non-ALK+ patients.

Some trials are for newly diagnosed patients and, although these may be available to ALK+ patients, it would be expected that ALK+ patients would start treatment with a TKI.

Usually, ALK+ patients would not seek clinical trials until they had exhausted standard treatments.

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 centers 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

NEW

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

NEW

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),

A Phase 1 Study of Antibody-Drug Conjugate MYTX-011.

NEW

For patients who have progressed on TKIs and chemotherapy.

Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations

NEW

The BTN116 trial drug is an investigational bispecific antibody

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes 

NEW

The adoptive cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphodepletion regimen, followed by infusion of autologous TIL followed by the administration of aldesleukin.

A phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors

NEW

An Antibody-Dependent Cell-mediated Cytotoxicity drug which is designed to enhance the immune system's ability to kill target cells.

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.

A Study Evaluating the Efficacy and Safety of Multiple Therapies in Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer 

This study will compare the effectiveness of Alectinib with an Immunotherapy for ALK patients diagnosed at Stage III but unable to have surgery.  The study will not report until 2033.

A Study Evaluating the Efficacy and Safety of Multiple Therapies in Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer 

This study will compare the effectiveness of Alectinib with an Immunotherapy for ALK patients diagnosed at Stage III but unable to have surgery.  The study will not report until 2033.

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.

UK Trials That Are No Longer Recruiting New Patients

Name

Summary of Contents

Action

Looking at Further Treatment After Initial Treatment for Advanced NSCLC (RAMON)

A study looking at further treatment after initial treatment for advanced non small cell lung cancer.  Not ALK+ specific.

Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients (ALKALINE)

The purpose of this study is to identify which patient populations may benefit most from treatment with Lorlatinib, based on the alterations found in their genes.  The study was due to complete in November 2024 but results have not yet been published.

Stereotactic Body Radiotherapy with Targeted Drug Treatment in Advanced NSCLC (HALT)

A trial of stereotactic body radiotherapy with targeted drug treatment in advanced non small lung cancer.  Report expected end 2025 or early 2026.

World-Wide Studies & Trials

Name

Summary

Action

ALK Positive (USA) Research Library

ALK Positive (USA) have collated a research library for patients to look through.

ALK+ Trials/Studies

A spreadsheet containing information of current clinical trials world-wide.

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

Plain English Report

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.

Funding Approved For a Vaccine In The UK

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

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