A Phase II, Non-comparative, Open label, Multi-centre, International Study of MEDI4736, in Patients with Locally Advanced or Metastatic Non‑Small Cell Lung Cancer (Stage IIIB-IV) who have received at least Two Prior Systemic Treatment Regimens Including One Platinum-based Chemotherapy Regimen (ATLANTIC)
This research, called the ATLANTIC study, is for people in the UK who have advanced non-small cell lung cancer that has spread or is difficult to treat (Stage IIIB-IV). Participants will have already tried at least two other types of treatment, including one chemotherapy that used a platinum-based drug. The study is testing a new medicine called IMFINZI, given as an infusion. Researchers want to understand how many people's tumours shrink or stop growing, how long these effects last, and how long people live overall. They are also carefully watching for any side effects the medicine might cause. This is a Phase II study, meaning it's exploring how well the new medicine works and is safe in a larger group of people.
At a glance
What is this study about?
This study, known as ATLANTIC, is investigating a new medicine called IMFINZI for individuals in the UK living with a type of lung cancer called non-small cell lung cancer. Specifically, it's for those whose cancer is advanced (Stages IIIB-IV), meaning it has spread beyond the lung or is harder to treat. Importantly, participants in this study would have already received at least two previous treatments for their cancer, including one type of chemotherapy that uses a platinum-based drug.
The main goal of the study is to see how many people respond to IMFINZI – meaning, how many see their tumours shrink or stop growing. The researchers will also be looking at how long this positive effect lasts, how long people live without their disease getting worse, and how long they live overall. They will also keep a very close eye on any side effects or unwanted reactions to the medicine, as patient safety is always a top priority.
This is a 'Phase II' study, which means it's an important step in developing new treatments. These studies help doctors understand if a new medicine works well enough and is safe enough to be tested in even larger studies. It's an 'open-label' study, which means both the patients and their doctors will know they are receiving the study medicine. It is also taking place in several hospitals, both within the UK and internationally.
Key takeaways
- Targets advanced non-small cell lung cancer.
- Investigates a new medicine called IMFINZI.
- For patients who have already had at least two previous treatments.
- Aims to assess tumour shrinkage, survival, and side effects.
- Participation involves regular hospital visits and monitoring.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
The most important medical requirement is that you have been diagnosed with advanced non-small cell lung cancer (Stage IIIB-IV). This means your cancer has spread beyond the main area or is more difficult to treat.
Another key point is that you should have already received at least two other treatments for your lung cancer. One of those previous treatments must have been a type of chemotherapy that used a platinum-based drug.
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 advanced non-small cell lung cancer (Stage IIIB-IV)?
- Have you already had at least two previous treatments for your lung cancer?
- Did one of your previous treatments include a platinum-based chemotherapy?
- Are you able to attend regular hospital appointments for treatments and tests?
What does participation involve?
If you join this study, you will receive the study medicine, IMFINZI, as an infusion. This means the medicine will be given to you through a drip into your vein. The schedule for these infusions and how often you'll need to visit the hospital will be clearly explained by the study team.
Throughout the study, you will have regular check-ups and tests. These will include scans (like CT scans) to see how your cancer is responding to the treatment, and blood tests to monitor your health and check for any side effects. The study team will carefully record all information about your health and any side effects you might experience.
The initial assessment of whether the treatment is working will happen about 24 weeks (roughly 6 months) after the last person joins that particular group in the study. Overall, monitoring for side effects and how long the effect of the medicine lasts will continue for a longer period, with the final overall survival analysis taking place about 12 months after the last patient has joined their group. You can expect to be involved in the study for a significant period.
Potential risks and benefits
Locations (1)
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Common questions
What kind of lung cancer is this study for?
This study is specifically for advanced non-small cell lung cancer (Stage IIIB-IV), which means the cancer has spread or is harder to treat.
What is IMFINZI?
IMFINZI is the name of the new medicine being tested in this study. It's given as an infusion, through a drip into your vein.
Have I had to have other treatments before joining?
Yes, you must have already tried at least two other treatments for your lung cancer, including one type of chemotherapy that contained platinum.
What will doctors be looking for in this study?
They want to see how many people's tumours shrink or stop growing, how long these effects last, how long people live, and to identify any side effects of the new medicine.
How long will I be in the study?
Your participation will involve regular visits and monitoring over a significant period. Tumour responses are checked after about 6 months, and overall survival after about a year from when the last person joins your group.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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