A trial comparing CT-322 and bevacizumab as treatment with chemotherapy for non small cell lung cancer (CA196005)

Who can enter

You can enter this trial if you

• Have non small cell lung cancer that has spread to another part of your body or has caused a collection of fluid around your lungs containing cancer cells (malignant pleural effusion)
• Have at least one area of cancer that your doctors can measure and which has not already been treated with radiotherapy
• 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 during the trial and for 6 weeks afterwards if there is any chance you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have lung cancer that is mainly squamous cell cancer
• Have cancer that has spread to your brain
• Have had major surgery or radiotherapy in the last 4 weeks, or minor surgery or radiotherapy for symptoms in the last 7 days
• Have already had chemotherapy for non small cell lung cancer
• Have a medical condition that puts you at an increased risk of bleeding, or you have coughed up more than half a teaspoonful of fresh blood
• Take drugs to thin the blood (anti coagulants) unless it is a low dose of aspirin
• Have had a stroke or a mini stroke (transient ischemic attack or TIA) in the last year
• Have high blood pressure that cannot be controlled with medication
• Have had a heart attack in the last 6 months or have any other heart problem that is a cause for concern
• Have had a wound in your tummy (abdomen) that has caused an abnormal opening (a fistula), or a collection of pus in the abdomen (an abscess) in the last 6 months
• Have an ulcer, a wound, or a broken bone that won’t heal, or areas of cancer on your skin that are bleeding
• Have certain kidney problems – the trial doctors can advise you about this
• Have an infection or any other serious medical condition that the trial doctors think could affect you taking part
• Have had another cancer in the last 4 years apart from non melanoma skin cancer, cancer in situ of the cervix, or cancer in situ of the bladder
• Are known to be sensitive to any of the drugs in this trial
• Are known to be HIV positive
• Are pregnant or breastfeeding

Trial design

This is a phase 2 trial, which will recruit about 250 people in different countries. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.

You have chemotherapy and the trial drugs in cycles of treatment. Each treatment cycle is 3 weeks. You have up to 6 cycles of chemotherapy. But as long as your cancer has not got worse, and you don’t have bad side effects, you can carry on having the CT-322 or bevacizumab for as long as it helps you.

People in group A have paclitaxel and carboplatin on day 1 of each 3 week cycle. And they have CT-322 once each week.

People in group B have chemotherapy in the same way. They have bevacizumab on day 1 of each cycle and a dummy drug (placebo) in weeks 2 and 3.

You have all the drugs through a drip into a vein. It takes about

• 3 hours to have paclitaxel
• Half an hour to have carboplatin
• An hour and a half to have the CT-322 or bevacizumab (or dummy drug)

The researchers will ask permission to get a sample of tissue that was taken in the past when you had surgery or a biopsy. If you don’t want to give this sample for research, you don’t have to. You can still take part in the trial.

The researchers will use the tissue sample and a blood sample taken at the start of the trial to study your DNA. This is to learn more about how genes may affect the way people respond to the drugs in this trial. They will also use the samples to try and find biomarkers. These are substances in the body that doctors can measure to help them see how a treatment is likely to work.

Hospital visits

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

• Physical examination
• Blood tests
• Urine tests
• Heart trace (ECG)
• Heart ultrasound (echocardiogram or MUGA scan)
• CT scan or MRI scan

You go to hospital for treatment every week. On day 1 of each treatment cycle, this takes at least 5 or 6 hours. On days 8 and 15 of each cycle, it takes at least an hour and a half. You have regular blood and urine tests throughout the treatment. And you have

• A scan every 6 weeks
• A heart ultrasound every 9 weeks

You will see the trials doctors again when you finish treatment. You have another ECG and more blood tests. If you are having side effects, the trial team will see you every 4 weeks, until these get better. And a member of the trial team will contact you or your doctor every 3 months to see how you are.

If you stop having treatment for any reason other than your cancer getting worse, you carry on having scans every 6 weeks for 6 months and then every 12 weeks until your cancer gets worse, or you start another treatment.

Side effects

As CT-322 is a new drug, there may be some side effects we don’t know about yet. From trials so far, the side effects doctors are aware of include

• Tiredness (fatigue)
• Feeling or being sick
• A mild rash
• Constipation
• Loss of appetite
• Headache
• Joint or back pain
• High blood pressure

The side effects of bevacizumab include

• Slow wound healing
• Damage to your bowel which can cause infection
• An increased risk of bleeding or blood clots
• Heart or kidney problems

The common side effects of chemotherapy include

• Fatigue
• Feeling or being sick
• Headaches
• Aching muscles or joints
• Constipation or diarrhoea
• Hair loss
• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

There is more information about the possible side effects of bevacizumab, paclitaxel and carboplatin on CancerHelp UK.