Radical management of advanced non-small cell lung cancer

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-further-treatment-after-initial-treatment-for-advanced-non-small-cell-lung-cancer

Background and study aims
Lung cancer is the most common cause of cancer death worldwide, and the majority of patients in the UK present with advanced disease. One-year survival is improving but remains low at 37% despite new treatments which now form the current standard of care for advanced lung cancer. Although these new treatments are very good, some cancer persists in most patients after treatment (termed ‘residual cancer’) and little is known about how best to deal with it. As such, management of residual advanced lung cancer varies across the UK, with some patients receiving only symptom management while others go on to have treatment in the form of surgery, radiotherapy and/or ablation with the aim to remove all remaining cancer within the lung and throughout the body. Collectively, these treatments are known as local consolidative treatment (LCT). LCT is intensive, impacts quality of life and is expensive but most importantly, it is not known whether it results in a better outcome for patients.
The aim of this study is to find out whether LCT alongside symptom management is worthwhile (or not) for patients with residual advanced lung cancer. Patients who agree to join the study will be divided into two equal-sized groups. One group will receive LCT alongside symptom management and the other group will receive symptom management alone. The study will compare the two groups' overall survival and quality of life, as well as the cost-effectiveness for the NHS.

Who can participate?
Patients aged 18 years and over with advanced stage (stage IV) non-small cell lung cancer who have undergone a course of initial systemic anti-cancer treatment.

What does the study involve?
After reading the study information and having discussions with the research team if necessary, participants will be asked to sign a consent form to document their willingness to take part in the study. As it is not known if it is better to have LCT alongside symptom management or have symptom management alone, the type of treatment a participant receives will be allocated through a process called randomisation (neither the participant, doctors/nurses nor the research team can choose which group a participant goes into). Each person has an equal chance of being in each group. The two groups a participant could be randomly allocated into are:
1. LCT (made up of surgery, radiotherapy and/or ablation) in addition to symptom management
2. Symptom management alone.
If a participant is allocated to receive LCT, their care team will decide on the most clinically appropriate type of treatment, in the form of surgery, radiotherapy and/or ablation for each current cancer site and any additional new sites that may arise. Where appropriate treatments to improve symptoms may also be given.
If a participant is allocated to receive symptom management alone, their care team will decide on the most clinically appropriate treatment(s).
Participants will also be asked to complete some questionnaires, once before they are randomised into the study; at 6 weeks after randomisation; and then every 6 months until the end of the study, for a minimum of 2 years and a maximum of 5 years. These questionnaires will give the study team information about a participant's quality of life and overall wellbeing.

What are the possible benefits and risks of participating?
It is hoped that any treatment a participant receives will help them, however this cannot be guaranteed. The information gained from the study may help improve the treatment of people with advanced lung cancer in the future.
The treatment received as part of either LCT or symptom management may result in a participant experiencing some side effects which will be explained by the treating clinician and also listed in the patient information sheet. The study may also result in increased exposure to ionising radiation which can also cause short-term side effects. Ionising radiation may also cause cancer many years or decades after the exposure however the chance of this happening to people with this clinical condition is extremely small.

Where is the study run from?
Bristol Trials Centre at the University of Bristol (UK)

When is the study starting and how long is it expected to run for?
August 2021 to June 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Miss Chloe Beard, ramon-study@bristol.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

Royal Brompton Hospital
Hospital/treatment centre

Royal Brompton & Harefield Hospitals
Sydney Street
London
SW3 6NP
England
United Kingdom

Phone	+44 (0)2073518109
Email	i.jakupovic@rbht.nhs.uk
Website	https://www.rbht.nhs.uk/our-hospitals
"ROR"	https://ror.org/00cv4n034

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

19/02/2025: The overall study end date was changed from 28/02/2027 to 30/06/2026.
29/01/2024: The recruitment end date was changed from 31/01/2025 to 12/01/2024. Total final enrolment added.
11/12/2023: Publication reference added.
05/12/2023: Clatterbridge Cancer Centre Wirral and Liverpool was added as a study participating centre.
11/10/2023: St Bartholomew’s Hospital and Southend University Hospital were added as study participating centres.
15/09/2023: University Hospitals of Leicester NHS Trust was added as a study participating centre.
05/09/2023: University Hospitals Plymouth NHS Trust was added as a study participating centre.
01/08/2023: Queen Elizabeth Hospital was added as a study participating centre.
27/07/2023: New Cross Hospital was added as a study participating centre.
29/06/2023: The study participating centres University Hospitals of Derby and Burton NHS Foundation Trust and Nottingham University Hospitals NHS Trust were added.
21/06/2023: The study participating centres Wythenshawe Hospital, Manchester University NHS Trust and Imperial College Healthcare NHS Trust were added.
20/03/2023: The trial participating centre Chelsea & Westminster Hospital NHS Foundation Trust was added.
23/02/2023: The recruitment start date has been changed from 10/01/2023 to 21/02/2023.
03/02/2023: Internal review.
24/01/2023: CRUK link added to plain English summary.
10/01/2023: The recruitment start date has been changed from 30/11/2022 to 10/01/2023.
14/11/2022: The recruitment start date has been changed from 02/11/2022 to 30/11/2022.
18/10/2022: The recruitment start date has been changed from 12/09/2022 to 02/11/2022.
17/10/2022: The ethics approval details have been added.
04/08/2022: Internal review.
22/07/2022: Trial's existence confirmed by the NIHR.