A trial looking at treatment for weight and muscle loss in people with lung cancer or pancreatic cancer

You may be able to enter this trial if you

• Have non small cell lung cancer that has spread OR pancreatic cancer that has spread
• Have or have not had chemotherapy in the past
• Have lost more than a twentieth (5%) of your body weight in the last 3 to 6 months without dieting
• Are well enough to be up and about for at least half the day (performance status 0, 1, or 2)
• Have satisfactory blood test results
• Have satisfactory blood pressure and temperature
• Are willing to use reliable contraception during the study and for 14 weeks after study treatment if there is any chance that you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have problems with your digestive system that stop you eating, including feeling or being sick, lack of appetite or a sore mouth
• Have taken part in a clinical trial in the last 3 weeks
• Have had treatment with bevacizumab (Avastin) in the last 8 weeks
• Have had radiotherapy in the last 4 weeks
• Have had major surgery in the last 3 weeks
• Are taking a high dose of steroids - your doctor will discuss this with you
• Have taken medication for weight loss in the last 4 weeks, for example megestrol acetate - your doctor will discuss this with you
• Have cancer in your brain or spinal cord (CNS) which is causing you problems
• Are unable to have an MRI scan
• Have any other medical problems that are a cause for concern
• Are pregnant or breastfeeding

This is a randomised trial. The people taking part are put into treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in.

Group 1 will have BYM338. Group 2 will have a dummy drug (placebo). You have BYM338 or the placebo once, through a drip into a vein. The treatment takes 2 hours.

After 8 weeks you find out if you were in group 1 or 2. If you were in group 1 and had BYM338 you have no further treatment. If you were in group 2 and had the placebo, you now have one treatment with BYM338.

There is no further treatment in this trial.

You fill out a questionnaire before you start treatment and then every 4 weeks for 16 weeks. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

During the trial researchers will ask your permission to take extra blood samples to use for research. If you don’t want to give extra blood samples for this trial, you don’t have to. You can still take part in the trial.

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

• Physical examination
• Heart trace (ECG)
• Blood tests
• Urine tests
• Being weighed
• MRI scan of your thigh
• CT scan
• A bone density scan (DXA)
• Muscle strength tests

You see the trial team and have these tests repeated every 4 weeks for 16 weeks. 

At times during the study you will wear a device that measures how active you are. This is called an activ PAL device. It attaches to your thigh. You wear it for 6 days. It does not hurt. The trial team will show you how it works.

The muscle strength tests include a hand grip strength test, how far you can walk comfortably in 6 minutes and how long you take to walk 10 metres. The trial team will explain what the tests involve.

You will be asked to keep a diary of how much and what you eat and how much exercise you do. The researchers ring you every week for 16 weeks to check how you are.

After 16 weeks the trial team will ring you every 4 weeks for 8 weeks to see how you are. This is the end of the trial.

As BYM338 is a new drug, there may be side effects we don’t know about yet. Possible side effects include

• Acne
• Diarrhoea
• Chest infections
• Changes to your liver
• Cramps in your muscles
• Sore mouth
• A fluttering heart beat (palpitations)
• A rash