Active not recruitingPHASE2INTERVENTIONAL

Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC

This study is for people with advanced lung cancer that has spread to other parts of the body. We are testing new treatment combinations that involve two drugs called durvalumab and tremelimumab. These are immunotherapy drugs, meaning they help your own immune system recognise and fight cancer cells. We're looking at whether giving these drugs together, sometimes with standard chemotherapy, works better than current treatments. Both durvalumab and tremelimumab have shown promising results in earlier studies by helping to shrink tumours. The aim is to find out if these combinations can slow down cancer growth or even make cancer cells die, offering new hope for treatment.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Canadian Cancer Trials Group

Enrolment target

301

Start

28 Mar 2017

Estimated completion

30 Jun 2026

Lung Cancer Metastatic

Results

Results from this study

Posted February 2022

Results have been published for this study.

Primary outcome

Overall Survival

time from randomization to the date of death

Full results on the registry

What is this study about?

This study is focused on a type of lung cancer that has spread to other parts of your body. We are particularly interested in two new types of drugs called durvalumab and tremelimumab. These drugs are not like traditional chemotherapy that attacks cancer cells directly. Instead, they are called 'immunotherapies' because they work by boosting your body's own immune system to find and fight the cancer.

Imagine your immune system as a defence army for your body. Sometimes, cancer cells are very good at hiding from this army. Durvalumab and tremelimumab help to uncover these hidden cells and reactivate your immune system's ability to attack them. This could potentially slow down the cancer's growth or even shrink the tumours. Both drugs have been studied individually in many people and have shown encouraging signs.

We also want to see if combining these two immune-boosting drugs with standard chemotherapy might give even better results. Researchers have already looked at durvalumab and tremelimumab together, but it's not yet clear if adding chemotherapy makes this combination more effective for your specific type of lung cancer. This study aims to provide answers to these important questions.

Key takeaways

This study evaluates new immunotherapy combinations for advanced lung cancer.
Immunotherapy helps your immune system fight cancer cells.
It might involve durvalumab, tremelimumab, and standard chemotherapy.
The study aims to find more effective treatments for metastatic non-small cell lung cancer.
You must not have had prior chemotherapy for advanced lung cancer.
Participation requires regular clinic visits and assessments.

Who may be eligible?

To be able to take part in this study, you must have been diagnosed with advanced non-small cell lung cancer that has spread to other parts of the body. Doctors will need to confirm the exact type of your lung cancer from tissue samples. If you have certain specific changes in your cancer cells (called EGFR mutations or ALK-fusion), you won't be able to join this study.

You also need to be at least 18 years old. Your general health and how well you can carry out daily activities will be assessed. We will also check your blood test results, such as your blood cell counts and how well your liver and kidneys are working, to make sure you are healthy enough for the study. If you've had chemotherapy for your advanced lung cancer before, this study wouldn't be suitable for you, but if you had chemotherapy a long time ago for cancer that was fully removed, you might still be able to join.

Finally, for us to measure how well the treatment is working, your cancer needs to be measurable on scans. This means there are specific parts of your cancer that can be accurately tracked for changes in size. You'll also need to agree to provide blood samples and tissue samples for further testing, which is an important part of understanding the study drugs.

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 I have advanced non-small cell lung cancer that has spread?
Am I at least 18 years old?
Have I NOT had chemotherapy for my advanced lung cancer yet?
Am I generally well and able to manage daily activities?
Do I have accurate scans of my cancer that can be measured?
Am I willing to provide blood and tissue samples for the study?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for assessments and to receive your study medication. You'll have blood tests, physical examinations, and scans to monitor your health and how the treatment is working. We'll be closely checking for any side effects. The exact schedule of visits and treatments would be explained in full detail by the study team, but generally, it involves ongoing treatment for a period, followed by regular check-ups. The total time you'd be involved in the study would depend on how your treatment progresses and could last many months, with long-term follow-up.

Potential risks and benefits

Taking part in this study could potentially offer you access to new treatments that might work better than current options for advanced lung cancer. However, like all medicines, durvalumab, tremelimumab, and chemotherapy can have side effects, which could be mild or more serious, and we don't yet know all the possible side effects of these combinations. The study team will explain all known risks. Participating is completely voluntary, and you have the right to leave the study at any time, for any reason, without it affecting your usual care.

Locations (49)

Campbelltown Hospital
Verified postcode
Campbelltown, Australia
Coffs Habour Health Campus - NCCI
Verified postcode
Coffs Harbour, Australia
Concord Repatriation General Hospital
Verified postcode
Concord, Australia
Nepean Hospital
Verified postcode
Kingswood, Australia
St. George Hospital, Cancer Care Centre
Verified postcode
Kogarah, Australia
The Tweed Hospital
Verified postcode
Lismore, Australia
Liverpool Cancer Therapy Centre, Liverpool Hospital
Verified postcode
Liverpool, Australia
Prince of Wales Hospital
Verified postcode
Randwick, Australia
Princess Alexandra Hospital
Verified postcode
Brisbane, Australia
The Prince Charles Hospital
Verified postcode
Chermside, Australia
Mater Research Institute South Brisbane
Verified postcode
South Brisbane, Australia
Gold Coast University Hospital
Verified postcode
Southport, Australia

Common questions

What kind of cancer is this study for?

This study is for people with advanced non-small cell lung cancer that has spread to other parts of the body.

What are durvalumab and tremelimumab?

They are new types of drugs called immunotherapies. They work by helping your body's immune system fight the cancer.

Will I definitely get the new drugs?

The study looks at different combinations, including immunotherapy with or without chemotherapy. The study team will explain your treatment plan.

Do I need to have had treatment for my cancer before?

You mustn't have had chemotherapy for your advanced lung cancer, but you might be eligible if you had chemotherapy for earlier-stage cancer a long time ago.

What does 'measurable disease' mean?

It means your cancer can be seen and measured on scans, so doctors can track if the treatment is working.