A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment with Atezolizumab or Placebo in Combination with Platinum-Based Chemotherapy in Patients With resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
This research study is looking into a new treatment approach for people with certain types of early non-small cell lung cancer that can be removed with surgery. Patients will receive either the drug Tecentriq, or a dummy drug (placebo), alongside standard chemotherapy before their operation. The main goal is to see if this combination helps people live longer without their cancer coming back, and if it's safe. Researchers will also be checking for side effects and how the treatment affects quality of life. This is a Phase 3 trial, which means it's a large study confirming if this new treatment is effective and safe compared to current standards.
At a glance
What is this study about?
This study is investigating a new way to treat certain types of lung cancer before surgery. If you have non-small cell lung cancer that is in an early stage (Stage II, IIIA, or some Stage IIIB) and can be removed by an operation, this research might be relevant to you. The idea is to give treatment before surgery to try and shrink the tumour or kill cancer cells, making the surgery more successful and potentially preventing the cancer from returning.
The main question this study wants to answer is whether adding a drug called Tecentriq to standard chemotherapy before surgery can help people live longer without their cancer coming back, compared to having chemotherapy with a dummy drug (placebo). Tecentriq is a type of immunotherapy that helps your body's immune system fight cancer. Researchers will carefully compare both groups to see if the combination with Tecentriq is more effective and safe.
They will be looking at several things, including how well the treatment shrinks the tumour, how long people live, whether the cancer returns, and people's general health and well-being during and after treatment. Understanding these aspects will help doctors decide if this new approach should become a standard treatment option for people with this type of lung cancer.
Key takeaways
- This study evaluates a new combination treatment for early-stage lung cancer before surgery.
- It combines standard chemotherapy with either Tecentriq (an immunotherapy) or a dummy drug.
- The main aim is to see if this approach helps patients live longer without cancer returning.
- Researchers will also carefully monitor safety, side effects, and quality of life.
- Participation involves receiving infusions, regular check-ups, and long-term follow-up.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. You need to have been diagnosed with non-small cell lung cancer that is in an early stage and your doctors believe it can be successfully treated with surgery.
There will be other medical checks to make sure you are healthy enough to take part and that the study treatment would be suitable for you. This includes your general health, other medical conditions you might have, and any medications you are currently taking. Your study doctor will review all your medical information to see if you meet all the requirements.
- Are you 18 years or older?
- Do you have early-stage non-small cell lung cancer?
- Has your doctor confirmed your cancer can be removed by surgery?
- Are you generally well enough to undergo chemotherapy and potential surgery?
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 would receive either the new drug Tecentriq or a dummy drug (placebo), in combination with standard chemotherapy before your planned surgery. These treatments are given as infusions, meaning they go directly into your bloodstream, usually over several hours. The chemotherapy drugs used could include Pemetrexed (Alimta), Gemcitabine, Carboplatin, or Cisplatin, and Abraxane.
You would have regular visits to the hospital or clinic for your treatments, check-ups, blood tests, and scans. Researchers will monitor you closely for any side effects and to see how your body is responding to the treatment. After your surgery, there will be follow-up appointments to track your health, check for any recurrence of cancer, and assess your quality of life. The total duration of your participation, including follow-up, could last for several years.
Potential risks and benefits
Locations (8)
- —Spain
- —France
- —Slovenia
- —Sweden
- —Austria
- —Germany
- —Poland
- —Italy
Common questions
What is non-small cell lung cancer?
It's the most common type of lung cancer, and 'early stage' means it hasn't spread widely yet.
What is 'neoadjuvant treatment'?
This means treatment given before surgery to shrink the tumour or kill cancer cells.
What is Tecentriq?
Tecentriq is an immunotherapy drug that helps your immune system find and fight cancer cells.
Will I definitely get the new drug?
No, this is a 'randomised' study, meaning you have an equal chance of receiving either Tecentriq or a dummy drug (placebo) along with chemotherapy.
What is a 'Phase 3' study?
Phase 3 is a large study that confirms if a new treatment is effective and safe compared to existing treatments.
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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