Phase 1/2 multicenter, two-arms, open-label, dose-escalation study of IDP-121 in combination with chemotherapy in patients with relapsed small cell lung cancer (SCLC) (MYCrocytic)
This UK-based study is for people with small cell lung cancer that has returned or spread and cannot be surgically removed. It's investigating a new medication called IDP-121, given alongside standard chemotherapy. The study has two main parts: first, finding the safest and most effective dose of IDP-121 (Phase 1), and then, seeing how well this new combination treatment shrinks tumours or controls the cancer in more people (Phase 2). Researchers will also be looking closely at any side effects and how patients' overall health changes during the study. This research aims to explore new treatment options for this type of lung cancer.
At a glance
What is this study about?
This study is looking into a new treatment for a type of lung cancer called small cell lung cancer (SCLC). This particular study is for people whose SCLC has come back (relapsed) after previous treatment, or has spread to other parts of the body (metastatic) and cannot be removed by surgery. The new treatment involves a drug called IDP-121, which will be given together with standard chemotherapy.
Clinical trials like this are done in different 'phases'. This study is combining Phase 1 and Phase 2. Phase 1 is about finding the safest dose of the new drug and figuring out if it has serious side effects. Doctors start with a very low dose and slowly increase it in small groups of people, watching carefully for any problems. Once they find a dose that seems safe and effective, they move to Phase 2. Phase 2 then checks how well this new treatment works in a larger group of people, specifically looking at whether it can shrink tumours or stop the cancer from growing.
The main goals of this study are to determine the best dose of IDP-121 to use with chemotherapy (in Phase 1) and then to see how many people respond to this new combined treatment (in Phase 2). Researchers will be carefully monitoring how the tumours respond, how long any improvements last, and also keeping a close eye on any side effects or changes in your overall health. The hope is to find a better treatment option for people with this type of lung cancer.
Key takeaways
- This study is testing a new drug (IDP-121) for small cell lung cancer that has come back.
- The new drug is given with standard chemotherapy.
- It aims to find the right dose and see how well it works against the cancer.
- You must be an adult (18+) with relapsed or metastatic small cell lung cancer that can't be operated on.
- Regular hospital visits and health checks are part of taking part.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part.
You would need to have been diagnosed with small cell lung cancer that has either come back after previous treatment or has spread to other parts of your body. Also, surgery must not be an option for your lung cancer.
There might be other health checks or requirements that your doctor will discuss with you to make sure the study is a safe and suitable option for your specific situation.
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.
- Are you 18 years old or older?
- Have you been diagnosed with small cell lung cancer?
- Has your small cell lung cancer come back or spread, and can't be removed by surgery?
- Are you generally well enough to start a new treatment?
What does participation involve?
If you join this study, you would receive the new drug called IDP-121, given as an infusion into your vein, along with standard chemotherapy. The study will involve regular visits to the hospital for your treatment and to have various checks done. These checks will include blood tests, urine tests, physical examinations, and heart recordings (ECGs) to monitor your health and see how you are responding to the treatment.
For the first part of the study (Phase 1), different groups of patients will receive increasing doses of IDP-121. The total duration of your participation would depend on how your cancer responds to the treatment and your general health, but you would be monitored regularly throughout.
Potential risks and benefits
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Common questions
What is small cell lung cancer?
It's a fast-growing type of lung cancer often linked to smoking, which can spread quickly.
What does 'unresectable' mean?
It means the cancer cannot be completely removed by surgery.
What is a 'dose-escalation study'?
It's the first step in testing a new drug, where small groups of patients get increasing doses to find the safest and most effective amount.
Will I know if I'm getting the new drug or not?
Yes, in this study, everyone knows they are receiving the new drug combined with chemotherapy.
How long will the treatment last?
The length of treatment depends on how well you respond and your general health. It will be discussed with the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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