"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of MPDL3280A for non small cell lung cancer (BIRCH)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called MPDL3280A for non small cell lung cancer. The study is for people with non small cell lung cancer that has grown into the surrounding tissue (locally advanced) or has spread to another part of their body (advanced).
Doctors can treat advanced non small lung cancer with treatments such as
The aims of this trial are to find out how well MPDL3280A works for people with advanced lung cancer and what the side effects are.
Who can enter
This trial is recruiting 3 different groups of people. To join the trial you must be in one of the following situations
- You haven’t had, or aren’t able to have, chemotherapy to treat your advanced cancer
- Your cancer has got worse during, or after treatment with chemotherapy that included a
- You have had 2 or more types of chemotherapy and one treatment included a platinum drug
And all of the following must apply
- You have non small cell lung cancer (NSCLC) that has spread into the surrounding tissue or lymph nodes (stage 3B) or has spread to another part of your body (stage 4)
- Your cancer has PD-L1 receptors (the trial team will test for this)
- Your cancer can be measured on a scan
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply. You
- Have cancer spread to your brain or spinal cord
- Have had an anti cancer treatment in the last 3 weeks apart from certain
biological therapiescalled TKIs (your doctor can tell you about this)
- Have taken part in another clinical trial in the past month
- Have pain due to your cancer and this cannot be controlled
- Have fluid collecting between the sheets of tissue covering your lungs (
pleural effusion) or fluid in your abdomen ( ascites) or fluid around your heart (pericardial effusion) that needs to be drained at least every month. If you have a tube that stays in place permanently to drain the fluid you may be able to take part
- Have had another cancer in the past 5 years apart from some
early cancersthat have been successfully treated (the trial team can advise you about this)
- Have or have had an
autoimmune disease(your doctor can tell you about this)
- Have another lung condition that could affect you taking part in this study (the trial team can advise you about this)
- Have HIV, hepatitis B or hepatitis C
- Have had a severe infection in the last month
- Have had signs or symptoms of an infection in the last 2 weeks
- Have certain heart problems (the trial team can advise you about this)
- Have had major surgery in the last month (apart from surgery to diagnose your lung cancer)
- May need to have surgery while taking part in the study
- Have had a
bone marrow transplant using cells from a donor
- Have had an organ transplant
- Have had a
vaccinein the last month or may need to have a vaccine while taking part in the trial
- Have had any drugs that work in a similar way to MPDL3280A (your doctor can tell you)
- Are allergic to MPDL3280A, similar drugs or anything they contain
- Have taken medication that stimulates your
immune systemin the last 6 weeks
- Have taken medication that dampens down your immune system in the last 2 weeks
- Are pregnant or breastfeeding
This is an international phase 2 trial. The researchers need 635 people to join. Everyone will have MPDL3280A.
You have MPDL3280A as an injection into a vein. When you have the 1st dose, it takes an hour. If you don’t have any problems, you can then have it over 30 minutes starting with your 2nd dose. You have it every 3 weeks.
You may be able to continue having it as long as your doctor thinks it is helping you and the side effects aren’t too bad.
The trial team will ask you to fill out a questionnaire before you start treatment, every 3 weeks during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
If you agree to take part in this trial, the researchers will ask for a sample of your cancer that was removed when you had surgery or a
If you haven’t had surgery or a biopsy, you must agree to have a biopsy before you can take part in the trial. Your doctor will talk to you about this.
The trial team will also ask for extra blood samples during treatment. They will use these samples to find out what happens to MPDL3280A in the body and to learn more about lung cancer.
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
- Heart scan (
ECHO) if needed
- Urine test
- CT scan or MRI scan
During treatment you see the doctor every 3 weeks. You have a physical examination, blood tests and a heart trace (if needed) each time. You will have a urine test every 6 weeks. You will also have a CT scan or MRI scan every 6 weeks to start with.
After treatment you will see, or be contacted by, the trial team approximately every 9 to 12 weeks for up to 5 years.
MPDL3280A is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Schmid
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Roche Products Limited