A trial looking at veliparib and chemotherapy for squamous cell non small cell lung cancer

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

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at a new drug called veliparib with chemotherapy for non small cell lung cancer. It is recruiting people with a type of non small cell lung cancer (NSCLC) called squamous cell cancer who cannot have surgery to remove it, or radiotherapy with the aim of curing their cancer.

Doctors usually use chemotherapy to treat advanced NSCLC to control the growth of cancer for as long as possible and to relieve symptoms. Researchers are always looking for ways to improve these standard treatments. In this trial they are looking at a drug called veliparib.

More about this trial

Veliparib (also known as ABT-888) is a type of biological therapy called a PARP inhibitor. It works by blocking a protein called PARP which is thought to help repair damage to DNA Open a glossary item in our cells. This damage can be caused by cancer treatments such as chemotherapy. If the action of PARP is stopped, it may mean that cancer cells can’t repair themselves and the chemotherapy has a better chance of working.

The aims of this trial are to find out

If veliparib and chemotherapy is a better treatment than chemotherapy alone for non small cell lung cancer (NSCLC)
How treatment with veliparib and chemotherapy affects quality of life

Who can enter

You may be able to join this trial if all of the following apply. You

Have a type of non small cell lung cancer (NSCLC) called squamous cell cancer (you may have a large area of cancer in your lung, or cancer that has spread to another part of your body)
Are not able to have surgery to remove your cancer or radiotherapy that aims to cure it (you may be able to take part if you have had surgery in the past but your cancer has come back)
Have cancer that can be measured on a scan
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 willing to use reliable contraception for 3 months before the trial, during the trial and for 6 months afterwards, if there is any chance that you or your partner could become pregnant
Are at least 18 years old
Agree that a sample of your cancer removed when you had surgery or a biopsy can be used by the researchers to look for substances called biomarkers

You cannot join this trial if any of these apply.

You have cancer that has spread to your brain or spinal cord (central nervous system)
You have had a fit (seizure) in the last year
You have had chemotherapy for advanced NSCLC (you may be able to take part if you had chemotherapy after surgery to try to stop the cancer coming back as long as this was more than a year ago)
You have had external radiotherapy in the last 4 weeks, or external radiotherapy to a smaller area (focal therapy) in the last 2 weeks, your doctor can explain this to your more
Your cancer has been tested and found to have a fault or change in a protein called epidermal growth factor receptors (EGFR positive cancer), or an overactive version of a protein called anaplastic lymphoma kinase (ALK)
You have had any other cancer in the last 3 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
You have already had treatment with a type of biological therapy called a PARP inhibitor
You are allergic to the drugs used in this trial
Have taken any herbal remedies in the last 2 weeks
You have problems with numbness and tingling in your hands and feet (peripheral neuropathy) unless this is only mild
You can’t swallow capsules
You have any other serious medical condition or mental health problem that the trial team think could affect you taking part

Trial design

This is an international phase 3 trial. The researchers need 900 people to join.

It is a randomised trial. The people taking part are put into 2 different 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. Everybody taking part has chemotherapy. The chemotherapy drugs used in this trial are carboplatin and paclitaxel.

People in one group have carboplatin, paclitaxel and veliparib
People in the other group have carboplatin, paclitaxel and a dummy drug (placebo )

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You have veliparib (or the dummy drug) as capsules twice a day for 7 days. You have one dose in the morning and one dose about 12 hours later in the evening. The trial team will tell you how many capsules you need to take each time.

You don’t take capsules for the next 14 days. This 3 week period is 1 cycle of treatment.

On the third day of taking your capsules, you go to hospital to have your chemotherapy. You have carboplatin and paclitaxel through a drip into a vein, this takes about 3 ½ hours. You have chemotherapy every 3 weeks.

You can have up to 6 cycles of treatment. So your treatment in this trial may last for about 4 ½ months.

The trial team will ask you to fill out a questionnaire before treatment and at regular points during and after your treatment (your trial team can give you more information about this). The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Blood tests
Physical examination
Heart trace (ECG )
CT scan

You go to hospital every day for the first 3 days of your treatment. Your next visit is 2 weeks later. You then go every 3 weeks for the rest of the time you have treatment. At each visit, you see a doctor who will ask about any side effects you have.

You may have extra hospital visits to have blood tests and a CT scan. You have scans twice during treatment. When you finish treatment, you have a scan every 6 weeks for the first year, then every 3 months.

As well as routine blood tests, you have some extra blood taken before you start treatment, once during treatment and when you finish treatment. The researchers will look at your blood samples to see how long veliparib stays in the body and to see if there are any substances in the blood to show that the treatment might be working (biomarkers Open a glossary item ). You have this blood taken at the same time as your routine blood tests.

The researchers will also ask your permission to use one blood sample (taken at the beginning of treatment) to look at the genetic information in your cells. An example of how this is used is to find out if this genetic information has anything to do with how the treatment works. If you don’t want to give these samples for genetic research, you don’t have to. You can still take part in the trial.

Once you have finished treatment you go to hospital for a check up every 6 weeks for the first year, then every 3 months until you choose to stop the trial, or your cancer starts to grow. You have a final trial visit where you have the above tests again.

Once you have finished all hospital visits as part of this trial, the researchers may continue to contact you every 2 months to collect information about your cancer. Or they may collect this information by looking at your medical records.

Side effects

The most common side effects of having veliparib with carboplatin and paclitaxel include

Hair loss
Numbness and tingling in your hands and feet (peripheral neuropathy)
Joint pain
Muscle pain
Shortness of breath and breathing problems

Other common side effects of veliparib (on its own and with other drugs) include

Feeling or being sick
Tiredness (fatigue)
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Diarrhoea
Loss of appetite
Constipation
Stomach pain
An effect on your liver which is unlikely to cause symptoms and usually goes back to normal on its own after treatment. You have regular blood tests to check how your liver is working
Headache
Feeling dizzy
Difficult falling asleep and staying asleep
High blood sugar
Low levels of sodium in the blood (you have regular blood tests to monitor this)
Taste changes