A clinical study to test the safety (any good or bad effects) of CC-90011 in combination with standard of care (cisplatin and etoposide), on how long the drug can stay in the body and if it can control the disease of people diagnosed with extensive small cell lung cancer and have not had any previous treatment for the disease. CC-90011, single agent, will be also given in consolidation after completion of the 4 to 6 cycles of chemotherapy
This research study is for people with extensive small cell lung cancer who haven't received treatment yet. It aims to test a new drug called CC-90011. Researchers want to find out if this medicine is safe and what side effects it might cause. They will also see how the drug moves through and leaves the body. The study will investigate if CC-90011, when given alongside standard chemotherapy (cisplatin and etoposide), can help control the cancer. After the initial chemotherapy, patients will also receive CC-90011 on its own to see if it continues to be effective in keeping the cancer at bay. This is an early phase study, meaning it's one of the first times this drug is being tested in humans to understand its basic effects.
At a glance
What is this study about?
This study is designed for adults who have been diagnosed with extensive small cell lung cancer. Extensive means the cancer has spread beyond the lung where it started or to other parts of the body. Importantly, this study is for people who have not yet received any treatment for their cancer.
The main goal of this research is to learn more about a new drug called CC-90011. Firstly, the study will check if this drug is safe to use and what any potential side effects might be. Secondly, researchers want to understand how the drug behaves in the body – how quickly it's absorbed, how long it stays, and how it's removed. Thirdly, they will be looking to see if CC-90011, when given together with the usual chemotherapy drugs (cisplatin and etoposide), can help to control the cancer.
After you finish the initial course of chemotherapy (which usually lasts 4 to 6 cycles), you would then receive CC-90011 on its own. This part of the study aims to see if the drug can continue to help keep your cancer under control after the main chemotherapy treatment has finished. This is an early-stage study, meaning it's one of the first times the new drug is being tested in people.
Key takeaways
- This study is for people with extensive small cell lung cancer who haven't had treatment before.
- It's testing a new drug called CC-90011 alongside standard chemotherapy.
- The study checks the drug's safety, how it works in the body, and its ability to control cancer.
- After chemotherapy, CC-90011 will be given on its own.
- This is an early-stage (Phase I) study to learn more about the new drug.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or over. This study is open to both men and women.
Your doctor will need to confirm that you have extensive small cell lung cancer and that you have not received any previous cancer treatment for this condition. There will be other specific health checks and tests to make sure that the study is safe and appropriate for you.
- I am 18 years old or older.
- I have been diagnosed with extensive small cell lung cancer.
- I have not yet received any treatment for my extensive small cell lung cancer.
- I am happy for my doctor to discuss other medical conditions I might have.
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive the new drug CC-90011 along with the standard chemotherapy drugs, cisplatin and etoposide. This initial treatment usually involves 4 to 6 cycles of chemotherapy. After completing these cycles, you would then receive CC-90011 on its own.
Taking part in a study usually means more hospital visits than usual. These visits will involve various tests and assessments, such as blood tests, scans, and physical examinations, to check your health, how the treatment is working, and to monitor any side effects. Your study doctor and nurse will explain the exact schedule of visits and tests, and the total duration of your participation, including follow-up appointments.
Potential risks and benefits
Locations (2)
- —Spain
- —Italy
Common questions
What is extensive small cell lung cancer?
It means the cancer has spread from where it started in the lung to other parts of the same lung, the other lung, or to other areas of the body. This is a common form of lung cancer.
What is CC-90011?
CC-90011 is a new drug being tested in this study. It's not yet approved for general use, and we are trying to learn more about how it works and if it's safe and effective.
What does 'standard of care' mean?
This refers to the usual and most accepted treatment for your type of cancer, which in this case is chemotherapy with cisplatin and etoposide.
Will I definitely get the new drug?
Yes, in this study, if you are eligible and choose to take part, you will receive CC-90011 along with the standard chemotherapy, and then CC-90011 on its own.
What is a 'Phase I' study?
This is an early stage of human testing. It mainly focuses on figuring out if a new drug is safe, what are the best doses, and how the body handles the drug.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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