A trial looking at Stimuvax for non small cell lung cancer (START)

Who can enter

You can enter this trial if

• You have stage 3 non small cell lung cancer (NSCLC) which cannot be removed with surgery
• Your lung cancer has either shrunk or is stable after treatment with chemotherapy and radiotherapy, and you finished the treatment at least 4 weeks ago but no more than 12 weeks ago
• You are well enough to take part (performance status 0 or 1)
• You have satisfactory blood results
• You are prepared to use reliable contraception while you are taking part in the trial if there is any chance that you or your partner could become pregnant
• You are at least 18 years old

You cannot enter this trial if you

• Have stage 4 non small cell lung cancer that has spread to another part of the body (metastatic cancer)
• Have had any treatment for your lung cancer apart from chemotherapy and radiotherapy
• Have fluid around your lungs (a pleural effusion) now, or had this when you were diagnosed
• Have had treatment with immunotherapy (including GCSF) in the last 4 weeks
• Have taken part in a clinical trial in the last 4 weeks
• Have had any other cancer in the last 5 years (apart from successfully treated non melanoma skin cancer or carcinoma in situ of the cervix)
• Have a medical condition affecting your immune system
• Have been taking steroids for a long time, or any other medicines that affect how well your immune system works (you may still take part if you are taking steroids to treat the side effects of radiotherapy)
• Have hepatitis B or hepatitis C
• Have a heart condition that is not controlled by medication (for example high blood pressure, angina or heart failure)
• Have had your spleen removed (splenectomy)
• Are taking any medicines or have another medical condition which the doctors think will affect your treatment or the results of this trial
• Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit 1,476 people into 2 groups. The people taking part are put into treatment groups by chance.

If you are in group 1 you will have Stimuvax injections. If you are in group 2 you will have dummy (placebo) injections. Both groups will get support from members of the health care team, such as the GP, physiotherapist and specialist nurses. This is called best supportive care.

More people will be put in to group 1 than group 2. The chance that you will be put in to group 1 (Stimuvax group) is 2 in 3. The chance that you will be put in to group 2 (placebo group) is 1 in 3. Neither you nor your doctor will be able to decide which group you are in, or will be told which group you are in. This is common in clinical trials and is called a double blind trial.

If you are in group 1, you will have a single dose of cyclophosphamide chemotherapy through a drip into your vein. The doctors know that this chemotherapy drug may help the Stimuvax to work better. 3 days later you have your first Stimuvax vaccine. You have each Stimuvax treatment as 4 small injections under the skin (subcutaneous injections). You will have these in the upper arms and tummy. You will have Stimuvax treatment once a week for 8 weeks. You then have the option of continuing with the injections every 6 weeks after that. Exactly how long you have the Stimuvax treatment will depend on how well you are and whether your cancer is growing or not.

If you are in group 2, you will have a single dose of saline (a solution of salt and water) through a drip into a vein. 3 days later you have your first dummy (placebo) injections. The placebo is an inactive substance but looks exactly like Stimuvax, and you have it in the same way. But it contains no active drug. You will have the placebo injections into the skin once every week for 8 weeks. You then have the option of continuing with the injections every 6 weeks after that. Exactly how long you have the placebo treatment will depend on how well you are and whether your cancer is growing or not.

You will be asked to fill in questionnaires as part of this trial. These are called quality of life questionnaires. They will ask you about how you have been feeling generally and how your lung cancer symptoms are. You will fill in the questionnaires

• Before you start the treatment
• During week 2, week 5 and week 8
• Every 6 weeks after that
• At the end of your treatment
• At 6 and 12 weeks after your last treatment
• At each long term follow up visit

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests include

• Blood tests
• Physical examination
• Heart trace (ECG)

You may also need to have a chest X-ray, CT scan or bone scan.

You will go to the hospital as an outpatient to have the cyclophosphamide or saline drip, and then again 3 days later for the Stimuvax or placebo injections. After that you will go to the hospital once every week for 7 weeks, and then every 6 weeks after that (if you choose to continue with the injections). Each visit will take about 2 hours. You will see the doctors and have a blood test after 4 weeks, 8 weeks, 19 weeks and every 12 weeks after that.

When you finish the treatment you will see the doctors after 6 weeks, 12 weeks, and then every 12 weeks after that. At your first follow up visit you will have a blood test, ECG and physical examination. You may also need to have another CT scan.

Side effects

The single dose of cyclophosphamide used in this trial is quite low. The most common side effect is feeling sick.

The most common side effects of Stimuvax are:

• Itching, swelling or redness at the injection site
• Flu like symptoms