
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at a new drug called selumetinib for non small cell lung cancer. This is for non small cell lung cancer (NSCLC) that has spread into surrounding tissues (locally advanced) or has spread to another part of the body (advanced).
Doctors can treat locally advanced and advanced NSCLC with chemotherapy. One combination of chemotherapy that doctors use is gemcitabine or pemetrexed with either cisplatin or carboplatin. This chemotherapy helps but doctors are always looking for ways to improve treatment.
Selumetinib is a type of anticancer therapy called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
The researchers think that combining selumetinib with gemcitabine or pemetrexed and cisplatin or carboplatin may be better than gemcitabine or pemetrexed and cisplatin or carboplatin alone.
The aims of this trial are to find out
You may be able to enter this trial if you
You cannot enter this trial if you
This is a phase 1 study. It will initially recruit 48 people. Everyone taking part will have selumetinib, gemcitabine and cisplatin or carboplatin.
The first few people recruited will have a low dose of selumetinib. If they don’t have any serious side effects, the next few people will have a higher dose of selumetinib. And so on, until they find the best combination dose to give. This is called a dose escalation study.
If this part of the trial goes well, it will recruit another 12 people.
Selumetinib is a capsule. You take them on an empty stomach. You can’t have any food or drink, apart from water, 2 hours before taking them or for 1 hour after taking them. You take them twice a day every day, if you have severe side effects you may need to stop taking them for a short period of time. This is called a drug holiday. Your doctor will talk to you about this if needed.
You have either gemcitabine or pemetrexed and either cisplatin or carboplatin as a drip into a vein. Your doctor will talk to you about how often you have them.
You continue having treatment as long as it is helping you and the side effects aren’t too bad.
If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you originally had a biopsy or surgery to remove your cancer. If you don’t want to give tissue samples for this study, you don’t have to. You can still take part in the trial.
The researchers will ask you for some samples of blood. They will use these to monitor your health during the study and to find out what happens to selumetinib in the body. They will also ask for some blood samples to help understand factors influencing cancer.
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor regularly to have a physical examination and blood tests. You have a have a heart scan every 3 months and a CT scan or MRI scan every 6 weeks for 6 months, then every 3 months.
You have another eye test a month after finishing selumetinib.
Selumetinib is a new drug and there may be side effects we don’t know about. The most common side effects include
You cannot eat Seville oranges or grapefruit, or drink their juices, while taking selumetinib because they can affect the way it works in your body.
The most common side effects of gemcitabine, pemetrexed, cisplatin and carboplatin are
Your doctor will talk to you about possible side effects before you agree to take part in the trial.
We have more information about
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Emma Dean
AstraZeneca
Experimental Cancer Medicine Centre (ECMC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”