Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Keith Boland
+44 20 7594 9480
refine-lung@imperial.ac.uk


Dr Michael Seckl
+44 20 3311 1421
m.seckl@imperial.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Reduced frequency pembrolizumab immunotherapy: can the frequency of pembrolizumab treatment for non-small cell lung cancer be reduced without reducing its effectiveness?

Reduced frequency pembrolizumab immunotherapy: can the frequency of pembrolizumab treatment for non-small cell lung cancer be reduced without reducing its effectiveness?

Medical Conditions

Lung cancer


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.



Background and study aims
Lung cancer is the most common cause of cancer death. Things have improved with the use of drugs like pembrolizumab, which is often used following a diagnosis of advanced non-small cell lung cancer (NSCLC). Pembrolizumab uses the immune system, the body’s natural defence. The immune system sends cells called T cells to fight infections and diseases. Cancer cells hide in the ‘PD-1/PD-L1 pathway’, allowing them to grow and spread. Pembrolizumab blocks the pathway. This prevents cancer cells from hiding, meaning they can be killed by T cells. The cancer may shrink or disappear as a result.
Treatment is usually every 6 weeks, sometimes with chemotherapy. Treatment can last 2 years, and this may be too much. Research has not shown that length increases benefit, and many people who stop before 2 years continue to benefit from pembrolizumab after it has finished.
There is a possibility that researchers can reduce treatment frequency without effectiveness being reduced. This is the main aim of REFINE-Lung.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

20 Jun 2022 30 Nov 2025

Participants will be randomly allocated to one of the following with or without chemotherapy until the cancer grows significantly:
- Pembrolizumab 6 weekly – the ‘control’ group, or standard treatment;
- Pembrolizumab 12 weekly.

After 150 participants are recruited, the researchers will see if 12 weekly is similar to 6 weekly, and if so 3 further groups will be opened:
- Pembrolizumab 9 weekly;
- Pembrolizumab 15 weekly;
- Pembrolizumab 18 weekly.

Up to 350 participants will be recruited into each group from up to 45 participating UK hospitals, 1750 in total. Each participant will be followed up for 18 months.


Eligible participants will be about to or already receiving pembrolizumab as first treatment for NSCLC.

You can take part if:



You may not be able to take part if:


1. Disease progression or not tolerating treatment at 6 months into therapy 2. Clinician does not intend to continue immunotherapy3. Is currently receiving an investigational agent or has participated in a study of an investigational agent and or used an investigational device within 28 days of randomisation

Added 04/07/2023:4. Any patient with a synchronous primary cancer. This includes any new cancer diagnoses or relapse of previously treated cancer since starting pembrolizumab treatment.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Beatson West of Scotland Cancer Centre
    1053 Great Western Road
    Glasgow
    G12 0YN
  • Royal Surrey County Hospital
    Egerton Road
    Guildford
    GU2 7XX
  • Royal Sussex County Hospital
    Eastern Road
    Brighton
    BN2 5BE
  • Christie Hospital
    Wilmslow Road
    Manchester
    M20 4BX
  • Weston Park Hospital
    Whitham Road
    Sheffield
    S10 2SJ
  • The Royal Marsden Hospital (surrey)
    Downs Road
    Sutton
    SM2 5PT
  • Northampton General Hospital NHS Trust
    Cliftonville
    Northampton
    NN1 5BD
  • Nottingham City Hospital
    Hucknall Road
    Nottingham
    NG5 1PB
  • Queens Hospital
    Rom Valley Way
    Romford
    RM7 0AG
  • Royal Derby Hospital
    Uttoxeter Road
    Derby
    DE22 3NE
  • Western General Hospital
    Crewe Road South Edinburgh
    Lothian
    EH4 2XU
  • Forth Valley Royal Hospital
    Stirling Road
    Larbert
    FK5 4WR
  • Kettering General Hospital
    Rothwell Road
    Kettering
    NN16 8UZ
  • North Devon District Hospital
    Raleigh Park
    Barnstaple
    EX31 4JB
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • Royal Bournemouth General Hospital
    Castle Lane East
    Bournemouth
    BH7 7DW
  • Victoria Hospital
    Hayfield Road
    Kirkcaldy
    KY2 5AH
  • Charing Cross Hospital
    Fulham Palace Road
    London
    W6 8RF
  • Royal Cornwall Hospital (treliske)
    Treliske
    Truro
    TR1 3LJ
  • Royal Devon and Exeter Hospital
    Royal Devon & Exeter Hospital Barrack Road
    Exeter
    EX2 5DW
  • Worthing Hospital
    Lyndhurst Road
    Worthing
    BN11 2DH
  • Calderdale and Huddersfield NHS Foundation Trust
    Trust Headquarters Acre Street Lindley
    Huddersfield
    HD3 3EA
  • Kingston Hospital
    Galsworthy Road
    Kingston upon Thames
    KT2 7QB
  • Yeovil District Hospital NHS Foundation Trust
    Higher Kingston
    Yeovil
    BA21 4AT
  • Poole General Hospital
    Longfleet Road
    Poole
    BH15 2JB
  • Ipswich Hospital
    Heath Road
    Ipswich
    IP4 5PD
  • Kent and Canterbury Hospital
    Ethelbert Road
    Canterbury
    CT1 3NG
  • Bristol Haematology & Oncology Centre
    Horfield Road
    Bristol
    BS2 8ED
  • St James's University Hospital
    Leeds Teaching Hospitals NHS Trust Beckett Street
    Leeds
    LS9 7TF
  • North Middlesex Hospital
    Sterling Way
    London
    N18 1QX
  • Peterborough City Hospital
    Edith Cavell Campus Bretton Gate Bretton
    Peterborough
    PE3 9GZ
  • Colchester General Hospital
    Colchester District General Hosp. Charter Way Turner Road
    Colchester
    CO4 5JL
  • St John's Hospital
    Howden West Livingston
    Lothian
    EH54 6PP
  • Velindre Cancer Centre
    Velindre Rd
    Cardiff
    CF14 2TL
  • Guys and St Thomas' NHS Foundation Trust
    249 Westminster Bridge Road
    London
    SE1 7EH
  • New Victoria Hospital
    52 Grange Rd
    Glasgow
    G42 9LF
  • Clatterbridge Cancer Centre - Liverpool
    Royal Liverpool University Hospital Prescot Street
    Liverpool
    L7 8XP
  • Barts Health NHS Trust
    West Smithfield
    London
    EC1A 7BE
  • The Royal Marsden Hospital
    Fulham Road
    London
    SW3 6JJ
  • Addenbrooke's Hospital
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ

Benefits:
Similar effectiveness but fewer side effects
Improved quality of life
Fewer visits to and savings by hospitals
Risks:
CT Scans: The risk of causing cancer from one scan is around 1 in 1,000, in a healthy person. The dose from a scan is similar to 9 years of background radiation. Subjects would receive the scans as part of their normal care and the risks are considered low because of their existing condition. The patient may find the CT scanner claustrophobic. A contrast dye may be used which may cause discomfort, bruising, swelling and sometimes an allergic reaction. Severe reactions are very rare.
Blood collection: There is a possibility of redness, swelling and bruising after collection and participants may feel lightheaded or faint. The blood samples collected are not above those that would be performed routinely.
Pembrolizumab: Pembrolizumab is a common treatment for NSCLC. The common side effects are related to the immune system and include itching/rash, diarrhoea, cough, muscle/joint pain, fever, abdominal pain, sickness, headache and tiredness. The research arms reduce the treatment frequency which may reduce the side effects and reduce the burden on patients. Participants may be hesitant about this causing disease progression, hence we have allowed re-escalation to 6-weekly treatment.
Pregnancy: The risks are unknown, however, patients are aware of this having been on this treatment for the previous 6 months. Women who become pregnant will be withdrawn and female and male subjects must agree to take appropriate precautions to avoid pregnancy or fathering a child.
Data Protection: Agreements will be in place prior to the transfer of data externally and pseudo-anonymised will be sent to avoid participant identification.
COVID-19: Patients are included in the at-risk categories but the aim of the study is to reduce the required visits. It is recommended that the vaccine be given as per current guidance for immunotherapy.
Additional visits: The patients will not have to attend hospital more than normal, except for an additional two visits for the screening and end of treatment.

Dr Keith Boland
+44 20 7594 9480
refine-lung@imperial.ac.uk


Dr Michael Seckl
+44 20 3311 1421
m.seckl@imperial.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Imperial College London and funded by Health Technology Assessment Programme.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: ISRCTN70247820

Or CPMS 52203

Last updated 28 August 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.