RecruitingPHASE1INTERVENTIONAL

A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC

This study, called CONCORDE, is for people with non-small cell lung cancer that hasn't spread too far. It's testing if giving new drugs (called DDR inhibitors) alongside standard radiotherapy can make the treatment more effective. These new drugs make it harder for cancer cells to repair themselves after radiotherapy. After radiotherapy, some patients may also receive another drug called durvalumab. The main goal is to find the safest and most effective dose of these drug combinations. Patients will receive their radiotherapy, and most will also get one of the new drugs. Everyone involved will know which treatment they are getting. We’ll carefully watch for side effects and how well the treatment works.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University of Leeds

Enrolment target

200

Start

17 Mar 2021

Estimated completion

01 Mar 2028

Non Small Cell Lung Cancer

What is this study about?

Radiotherapy is a common and often successful way to treat non-small cell lung cancer when it’s still contained in the chest area. This treatment works by damaging the cancer cells’ DNA, which eventually kills them. However, cancer cells can be quite good at repairing this damage, which means the cancer can sometimes come back.

This study is testing a new approach. We're looking at giving special new drugs called 'DNA damage response inhibitors' (DDR inhibitors) at the same time as radiotherapy. These drugs are designed to stop cancer cells from repairing themselves after radiotherapy, hopefully making the radiotherapy much more effective. After this initial treatment, some patients in certain groups will also receive another drug called durvalumab, which is a type of immunotherapy that helps the body's immune system fight cancer.

The main aim of this study is to find the best and safest dose of these new drug combinations when given with radiotherapy. We will also carefully watch for any side effects and see how well the treatment works against the cancer. We hope this research can lead to better treatment options for people with non-small cell lung cancer.

Key takeaways

Tests new drugs with radiotherapy for non-small cell lung cancer.
Aims to make radiotherapy more effective by stopping cancer cells from repairing themselves.
No placebo drugs are used; everyone knows their treatment.
Includes regular monitoring for safety and treatment response.
Could last over a year for follow-up.
Patients can leave the study at any time.

Who may be eligible?

Most people joining this study will have non-small cell lung cancer that hasn't spread to other parts of the body, and their medical team believes radiotherapy could cure or significantly help them. You would need to be 18 years or older, generally in good health, and expected to live for at least another six months. Your lung function also needs to meet certain levels.

The study would not be suitable if your cancer is a mix of non-small cell and small cell types, or if your cancer has gotten worse during previous chemotherapy. You also shouldn't have taken part in another experimental drug study in the last four weeks. If you are female and could become pregnant, or male, you would need to use effective contraception during and for some time after the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have non-small cell lung cancer that hasn't spread widely?
Are you aged 18 or older?
Is your medical team planning radiotherapy for your cancer?
Are you generally well and active?
Have you not had another experimental drug in the last 4 weeks?
If relevant, are you able to use effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive your planned radiotherapy treatment. About three out of every four participants will also receive one of the new DDR inhibitor drugs alongside their radiotherapy. Both you and your doctors will know which treatment you are getting; no placebos (dummy treatments) are used. In some parts of the study, you might also receive the drug durvalumab after your radiotherapy.

Throughout the study, you'll have regular hospital visits for check-ups. This will involve physical examinations, blood tests, and scans to monitor your health, look for any side effects, and see how your cancer is responding to treatment. The overall duration of your participation could be up to 13.5 months from the start of your radiotherapy, allowing us to track any longer-term effects.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new treatment combination that could potentially make your radiotherapy more effective against your cancer. However, all new treatments carry potential risks, and you might experience different or more side effects than you would with standard radiotherapy alone. Your doctors will carefully monitor you for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Belfast City Hospital
Verified postcode
Belfast, United Kingdom· Recruiting
Birmingham Heartlands Hospital
Verified postcode
Birmingham, United Kingdom· Recruiting
Addenbrooke's Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting
Velindre Cancer Centre
Verified postcode
Cardiff, United Kingdom· Recruiting
The Royal Marsden Hospital Chelsea
Verified postcode
Chelsea, United Kingdom· Recruiting
Western General Hospital
Verified postcode
Edinburgh, United Kingdom· Recruiting
St James's University Hospital
Verified postcode
Leeds, United Kingdom· Recruiting
The Clatterbridge Cancer Centre
Verified postcode
Liverpool, United Kingdom· Recruiting
St Bartholomew's Hospitals
Verified postcode
London, United Kingdom· Recruiting
University College Hospital London
Verified postcode
London, United Kingdom· Recruiting
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Trust
Verified postcode
Newcastle upon Tyne, United Kingdom· Recruiting

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study is for people whose cancer hasn't spread far from the lung area.

What are DDR inhibitors?

These are new drugs that make it harder for cancer cells to repair damage caused by radiotherapy, aiming to make the radiotherapy work better.

Will I get a dummy drug (placebo)?

No, there are no placebos in this study. Both you and your doctors will know if you are receiving one of the study drugs.

How long will I be in the study?

Your participation could last up to about 13 and a half months from when you start radiotherapy, to allow for monitoring.

What is durvalumab?

Durvalumab is an immunotherapy drug that helps your body's immune system fight cancer, and it might be given after radiotherapy in some study groups.

How to find out more

Jamie B Oughton, MPhil

ctru_concorde@leeds.ac.uk 0113 343 1494 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.