A Phase 2 Open-label Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants with Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies
This research study is looking at a new treatment called farletuzumab ecteribulin for a type of lung cancer known as metastatic non-small cell lung cancer (adenocarcinoma). This is for people whose cancer has spread and hasn't improved with other treatments. The main goal of the study is to carefully monitor any side effects and understand how safe this new medicine is for patients. Researchers will be tracking various health changes, serious side effects, and any effects that might lead someone to stop the treatment. They will also look at how often certain side effects happen. This is a Phase 2 study, meaning it's still in the earlier stages of testing, focusing on safety before looking more closely at how well it works.
At a glance
What is this study about?
This clinical trial is designed to investigate a new medication called farletuzumab ecteribulin. This drug is being developed for people who have metastatic non-small cell lung cancer, which is a type of lung cancer that has spread to other parts of the body. Specifically, it's for those whose cancer has not responded to other treatments they've already received.
The main purpose of this study is to find out if farletuzumab ecteribulin is safe and what side effects it might cause. Researchers will be keeping a very close eye on the health of everyone taking part. They'll record all side effects, both mild and serious, and see if any cause people to stop the treatment. This helps them understand what to expect if this drug eventually becomes available to more patients.
While the primary focus is on safety, the study will also look at how well the treatment might be working against the cancer. This information helps doctors decide if the drug should be studied further in larger groups of people. It's an important step in bringing new, potentially helpful treatments to patients who need them.
Key takeaways
- This study is testing a new drug for advanced lung cancer (adenocarcinoma).
- It's for people whose cancer hasn't responded to previous treatments.
- The main goal is to check the safety and side effects of the new medicine.
- Participants will receive the new treatment and be closely monitored.
- It's an early-stage (Phase 2) study.
Who may be eligible?
To be able to take part in this study, you must be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also be considered.
The study is for people who have a specific type of lung cancer called metastatic non-small cell lung cancer (adenocarcinoma). This means your lung cancer has spread to other parts of your body. Also, it’s important that you have already tried other treatments for your cancer, and these treatments were not successful in stopping or improving your condition.
Both men and women can join this study. The medical team will check other specific health details to make sure the study is a good fit for you and safe for you to participate.
- Are you 18 years old or older?
- Do you have metastatic non-small cell lung cancer (adenocarcinoma)?
- Has your cancer spread to other parts of your body?
- Have you already tried other treatments for your lung cancer that didn't work well?
- Are you able to attend regular clinic appointments and undergo medical tests?
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 in this study, you will receive the new medicine, farletuzumab ecteribulin, as part of the treatment. The study doctors and nurses will regularly monitor your health very closely. This will involve scheduled visits to the clinic for medical examinations, blood tests, and other assessments to check for any side effects and see how your body is responding. The exact number of visits and tests will be detailed by the study team.
Your safety is the top priority throughout the study. Therefore, any side effects, whether mild or serious, will be carefully documented and managed. You'll have regular contact with the study team who can answer your questions and support you. The total length of your participation will depend on how you respond to the treatment and the study plan, which the doctors will explain in detail.
Potential risks and benefits
Locations (2)
- —Spain
- —France
Common questions
What kind of lung cancer is this study for?
This study is specifically for metastatic non-small cell lung cancer, which is a type of lung cancer that has spread to other parts of the body, and specifically the adenocarcinoma type.
What is a 'Phase 2' study?
A Phase 2 study means it's an earlier stage of research where doctors are mainly looking at how safe the new medicine is and what side effects it might cause, while also getting a first look at how well it works.
Will I definitely get the new medicine?
Yes, in this specific study (it's 'open-label'), everyone who joins will receive the new medicine, farletuzumab ecteribulin.
What does 'adverse event' mean?
An adverse event is medical jargon for any unwanted or unexpected health problem that happens to someone while they are in the study, whether it's related to the treatment or not. The study will track these carefully.
Can I stop participating in the study if I change my mind?
Yes, you have the right to leave the study at any time, for any reason, without your regular medical care being affected.
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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