A trial of ipilimumab with chemotherapy for small cell lung cancer (CA184156)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer
Small cell lung cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at a drug called ipilimumab alongside chemotherapy for people who have been recently diagnosed with small cell lung cancer (SCLC). The people taking part have SCLC that has spread into lymph nodes outside the lung or to other body organs. This is called extensive stage disease.

Doctors usually treat extensive stage SCLC with chemotherapy. Combinations of chemotherapy drugs tend to work better than single drugs. Doctors may combine cisplatin or carboplatin with another drug such as etoposide.

In this trial, researchers are looking at adding a drug called ipilimumab to chemotherapy. Ipilimumab is a type of biological therapy called a monoclonal antibody.

The aim of the study is to see if chemotherapy and ipilimumab is better than chemotherapy alone for people who have been recently diagnosed with extensive stage small cell lung cancer.

Who can enter

You may be able to enter this trial if you

  • Have been diagnosed with small cell lung cancer (SCLC) that has spread into lymph nodes outside the lung or to another part of your body (extensive stage disease)
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have satisfactory blood test results
  • Are at least 18 years old
  • Are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have cancer that has spread to your brain, is causing symptoms and needs treatment - you may be able to take part if cancer spread to your brain was diagnosed at least a month ago, has been treated with radiotherapy, has not got any worse in the last month and you don’t need steroids or medication to prevent fits (seizures)
  • Have a build up of fluid between your chest wall and lung (a pleural effusion) that cannot be controlled
  • Have already had a treatment for lung cancer that reaches your whole body (systemic treatment)
  • Have had any other cancer in the last 5 years, apart from carcinoma in situ of the cervix, very early (superficial) bladder cancer, non melanoma skin cancer, or another cancer that is considered cured and doesn’t need any further treatment
  • Have had immunotherapy as cancer treatment
  • Have already had a drug that works in a similar way to ipilimumab – the trial team can advise you about this
  • Have nerve damage in your fingers or toes (peripheral neuropathy) unless this is mild
  • Have an autoimmune disease
  • Take steroids or other drugs that damp down your immune system on a long term basis
  • Have had a serious skin condition called toxic epidermal necrolysis (TEN)
  • Have certain other lung conditions – the trial team can advise you about this
  • Have any other serious medical condition or mental health problem that could affect you taking part
  • Have HIV, hepatitis B or hepatitis C
  • Are pregnant or breastfeeding

Trial design

This phase 3 trial will recruit about 1,100 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

Half the people have chemotherapy and ipilimumab. The other half have chemotherapy and a dummy drug (placebo).

The chemotherapy you have in this trial is a combination of etoposide and either cisplatin or carboplatin - your specialist will decide which one is best for you to have. This is called induction chemotherapy.

You have the drugs every 3 weeks through a drip into a vein. Each 3 week period is called a cycle of treatment. As long as your cancer is not getting worse and you don’t have bad side effects, you have up to 6 cycles of chemotherapy, lasting 18 weeks all together. From the 3rd cycle of treatment onwards, you have ipilimumab (or the dummy drug) as well.

CA184156 trial diagram

If your cancer gets smaller (partial response) or disappears completely (complete response) during induction treatment, the trial team will talk to you about having radiotherapy to your head to reduce the risk of cancer spreading to your brain. This is called prophylactic cranial irradiation (PCI). If you do have PCI, you have radiotherapy daily for 3 weeks.

The team may then talk to you about carrying on having ipilimumab or the dummy drug on its own. This is called maintenance therapy. Depending on which group you were in, you have ipilimumab or the dummy drug through a drip into a vein once every 12 weeks until your cancer starts to get worse.

If you have radiotherapy to your brain (PCI), it will start at least 3 weeks after your last cycle of induction chemotherapy. Maintenance therapy starts between 9 and 12 weeks after you finish induction treatment.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

You go to hospital once every 3 weeks during the induction chemotherapy. You have regular blood tests. You have a heart trace (ECG) in the 7th week of treatment to look for any changes to your heart rhythm. You have a CT or MRI scan every 6 weeks.

The trial team will ask you to fill out a questionnaire at each hospital visit. It will ask about how you are feeling and how you feel about your disease.

If you have radiotherapy to your brain, you go to hospital every day for 3 weeks.

If you have maintenance treatment with ipilimumab or the dummy drug, you go to hospital every 12 weeks for a scan and treatment. You have blood tests before each treatment and the trial team will ask you to fill out questionnaires at the first 4 hospital visits during maintenance treatment.

When you finish treatment, you see the trial team about 6 weeks later. You have a physical examination and more blood tests. They will ask about any side effects you have and you fill out another questionnaire. After that, you see the trial team (or speak to them on the phone) every 3 months.

Side effects

The common side effects of ipilimumab include

We have more information about the side effects of etoposide, cisplatin and carboplatin in our cancer drugs section.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Paul Lorigan

Supported by

Bristol-Myers Squibb
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9576

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think

Share this page