A Phase I/III, Multi-center, Randomized, Double-blind Study of BAT3306 plus Chemotherapy versus Keytruda® plus Chemotherapy to Evaluate Pharmacokinetics, Efficacy, and Safety in Participants with Stage IV Non-squamous Non-small Cell Lung Cancer.
This research study is for adults with a type of advanced lung cancer called Stage IV non-squamous non-small cell lung cancer. It aims to compare a new medicine, called BAT3306, with a commonly used treatment, Keytruda®. Both BAT3306 and Keytruda® are given alongside standard chemotherapy medicines. The main goals are to understand how safe each treatment is, how well they work to shrink cancer or stop it from growing, and how the body handles these drugs. Participants will be randomly assigned to receive either the new drug or Keytruda®, both with chemotherapy. This is a crucial step in finding potentially better ways to treat this type of lung cancer.
At a glance
What is this study about?
This study is looking into a type of lung cancer called Stage IV non-squamous non-small cell lung cancer. 'Stage IV' means the cancer has spread to other parts of the body. 'Non-squamous non-small cell' describes the type of lung cancer cells under a microscope. We're testing a new treatment called BAT3306 alongside standard chemotherapy, and comparing it to an existing treatment, Keytruda®, also given with chemotherapy. The new drug, BAT3306, is a special kind of medicine designed to help the body's immune system fight cancer.
The main reasons for doing this study are to: 1) see how safe the new treatment is and if it causes any side effects, 2) check how well it works compared to Keytruda® in shrinking the cancer or stopping it from growing, and 3) understand how the new drug moves through the body.
By comparing these treatments, doctors hope to find out if BAT3306 could be a good new option for people with this type of lung cancer. This research is a really important step in developing new and potentially more effective ways to fight cancer.
Key takeaways
- Compares a new drug (BAT3306) with Keytruda® for advanced lung cancer.
- Both treatments are given with standard chemotherapy.
- Aims to check safety, effectiveness, and how drugs work in the body.
- Participants are randomly assigned to a treatment group.
- Close monitoring with tests and scans will be part of the study.
- You can stop participating 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 must have been diagnosed with Stage IV non-squamous non-small cell lung cancer.
There will be other specific medical requirements that your doctor will need to check. These might include your general health, other medical conditions you have, and any previous treatments you've received for your cancer.
It's important to discuss all your medical history with your doctor to find out if this study is suitable for you.
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?
- Do you have Stage IV non-squamous non-small cell lung cancer?
- Are you able to attend regular clinic visits for treatment and tests?
- Are you willing to be randomly assigned to one of the study treatment groups?
What does participation involve?
If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. You won't know which group you're in, and neither will your doctor – this is called 'double-blind'. One group will receive the new drug BAT3306 with chemotherapy, and the other will receive Keytruda® with chemotherapy. You will receive these treatments through an infusion, which means the medicine will be given directly into your bloodstream through a drip, usually in your arm.
You'll have regular visits to the clinic for your treatments and to have various tests done. These tests might include blood tests to check how the drug is affecting your body and to monitor the cancer, physical examinations, and heart checks (ECGs). You'll also have scans to measure your tumour and see how it's responding to the treatment. These check-ups will continue throughout your treatment period and for a follow-up period afterwards to monitor your health and any long-term effects. The total duration of your participation will depend on how you respond to the treatment, but study treatments can continue for months, with follow-up lasting even longer.
Potential risks and benefits
Locations (1)
- —UnverifiedSlovakia
Common questions
What kind of lung cancer is this study for?
This study is for a specific type of advanced lung cancer called Stage IV non-squamous non-small cell lung cancer.
What are the treatments being tested?
We are comparing a new drug called BAT3306 with an existing treatment, Keytruda®, both given along with standard chemotherapy.
Will I know which treatment I'm getting?
No, you won't know which treatment you're receiving, and neither will your doctors. This is to make the study fair and accurate.
How long will I be in the study?
The treatment phase can last for several months, and you'll have follow-up monitoring for a longer period afterwards, depending on your response.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time for any reason, and your medical care will not be 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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