A randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant in combination with carboplatin and pemetrexed in adults with nonsquamous non-small cell lung cancer who have progressed on immunotherapy
This important UK clinical trial is looking at a new treatment called inupadenant. It's for adults with a specific type of lung cancer called nonsquamous non-small cell lung cancer. This is for patients whose cancer has grown or spread even after they've had immunotherapy. The study will combine inupadenant with two chemotherapy medicines, carboplatin and pemetrexed, which are already used treatments. The main goal is to find out if adding inupadenant can help keep the cancer from growing for a longer time. Researchers will also be carefully checking for any side effects and how patients feel overall. This study aims to find better ways to treat this kind of lung cancer.
At a glance
What is this study about?
This study is about finding new and better ways to treat a type of lung cancer called nonsquamous non-small cell lung cancer. This particular study is for people whose cancer has unfortunately not responded well to, or has progressed after, their initial immunotherapy treatment. Immunotherapy helps your body's immune system fight cancer, but it doesn't work for everyone, or it might stop working over time.
The researchers are testing a new drug called inupadenant. They want to see how it works when given alongside two standard chemotherapy drugs, carboplatin and pemetrexed. The study is divided into two main parts. The first part is about carefully finding the right dose of inupadenant that is safe and can be tolerated by patients. This involves closely watching for any side effects and how patients react to the treatment.
The second part of the study will then compare the new combination treatment (inupadenant plus chemotherapy) with the standard chemotherapy alone. The main thing they will be looking for is how long patients live without their cancer growing or getting worse. They will also be tracking overall survival and how the treatment affects patients' quality of life, including symptoms like shortness of breath and pain. This kind of research is vital for developing new treatments and improving the lives of people with cancer.
Key takeaways
- This study is testing a new drug for a type of lung cancer.
- It's for patients whose cancer has progressed after immunotherapy.
- The new drug will be combined with standard chemotherapy.
- The main goal is to see if the cancer can be controlled for longer.
- Your health and well-being will be closely monitored throughout.
Who may be eligible?
This study is looking for adults aged 18 and over, of any gender. To join, you must have been diagnosed with nonsquamous non-small cell lung cancer and have already received immunotherapy. It's important that your cancer has started to grow or spread even after this immunotherapy treatment.
There will be other health requirements and tests to make sure that the treatment is safe for you. These might include checking your general health, blood tests, and other scans. These details are important to protect your safety and ensure the study results are clear.
Your specialist doctor will be able to tell you if your specific situation matches all the requirements for this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am 18 years old or older.
- I have nonsquamous non-small cell lung cancer.
- My cancer has recently worsened after receiving immunotherapy.
- I am willing to follow the study's treatment and visit schedule.
- I understand I might receive a placebo in addition to chemotherapy.
What does participation involve?
If you join this study, it would involve several visits to the hospital or clinic. In the first part of the study, the medical team will carefully decide the best dose of the new medicine for you, keeping a close eye on any side effects. In the second part of the study, you would be randomly assigned to either receive the new medicine (inupadenant) plus two chemotherapy drugs, or the two chemotherapy drugs with a placebo (a dummy pill that looks like inupadenant).
Throughout the study, you would have regular assessments. These will include check-ups by doctors, blood tests, and scans (like X-rays or CT scans) to see how the treatment is working and monitor your health. You might also be asked to fill out questionnaires about how you are feeling and your quality of life. The total duration of your participation would depend on how your treatment is progressing and the study's design.
Potential risks and benefits
Locations (6)
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedItaly
Common questions
What type of cancer is this study for?
It's for adults with nonsquamous non-small cell lung cancer that has worsened after immunotherapy.
What is 'inupadenant'?
It's a new medicine being tested in this study, given alongside standard chemotherapy.
Will I definitely get the new medicine?
In the main part of the study, you would be randomly assigned to either get the new medicine plus chemotherapy, or chemotherapy with a placebo (dummy pill).
What are researchers hoping to find?
They want to see if the new combination can help control the cancer for longer and improve patients' overall health.
Can I stop participating if I want to?
Yes, you can leave the study at any time, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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