C6461010 - An Interventional, Open-Label, Phase 2 Study to Investigate the Safety and Efficacy of PF-08634404 Monotherapy or in Combination in Adult Participants with Early-Stage Resectable or Locally Advanced Unresectable Non-Small Cell Lung Cancer
Non-small cell lung cancer is the most common form of lung cancer. This Phase 2 clinical trial looks at an experimental medicine called PF-08634404. Doctors want to understand its safety, side effects, and how well it treats lung cancer compared to existing options. Participants will receive PF-08634404 either alone or combined with standard chemotherapy drugs such as carboplatin, paclitaxel, or pemetrexed. The study includes people with early-stage cancer that can be removed with surgery, as well as those with cancer that has spread nearby and cannot be operated on. For patients having surgery, researchers will check if giving this treatment beforehand shrinks the tumour and whether it causes any healing problems afterwards. For those who cannot have surgery, the study checks whether the treatment helps control the cancer and improves quality of life.
At a glance
What is this study about?
Lung cancer is one of the most common cancers worldwide, and non-small cell lung cancer is the type diagnosed most often. Standard care usually involves surgery, chemotherapy, radiotherapy, or a mixture of these. However, doctors are always looking for better treatments that can stop cancer returning or control it for longer with fewer side effects.
This clinical trial is studying an experimental medicine known as PF-08634404. The main goal is to find out if this medicine is safe and if it works well against lung cancer. It is being tested on its own and also in combination with well-known chemotherapy medicines such as carboplatin, paclitaxel, and pemetrexed.
The trial is divided into different groups depending on the stage of cancer. Some participants have early-stage cancer that a surgeon can remove. For these patients, the trial medicine is given before surgery to see if it can clear away cancer cells and make the operation more successful. Other participants have cancer that has grown into nearby tissues and cannot be safely removed by surgery. For this group, doctors want to see if the medicine can shrink the tumours and keep the disease stable.
By taking part, participants provide vital information. The findings will help researchers understand whether PF-08634404 could become a helpful new treatment option for lung cancer patients in the NHS and across the world.
Key takeaways
- Phase 2 clinical trial testing a new medicine called PF-08634404 for non-small cell lung cancer.
- Open to adults with early-stage cancer suitable for surgery, or locally advanced cancer that cannot be operated on.
- The new medicine is tested on its own and in combination with standard chemotherapy.
- The main goals are to check safety, monitor side effects, and see if tumours shrink.
- Taking part is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with non-small cell lung cancer. It includes both people whose tumours can be removed by surgery and those whose tumours cannot be operated on because the cancer is locally advanced.
To take part, you must be well enough in your everyday life to manage clinic visits and cancer treatments. Your heart, liver, and kidneys will also need to be working reasonably well, which the study team will check with simple tests.
You may not be eligible if you have certain other serious medical conditions, an active autoimmune disease, or severe lung problems unrelated to your cancer. The hospital research team will look closely at your medical history, scans, and blood results to help you decide if joining is safe and 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.
- I am aged 18 or older.
- I have been diagnosed with non-small cell lung cancer.
- My cancer is either early-stage (suitable for surgery) or locally advanced (not suitable for surgery).
- I am well enough to attend regular hospital appointments and have routine tests.
- I am open to receiving an experimental medicine alongside or instead of standard chemotherapy.
What does participation involve?
If you take part, your treatment will depend on which group of the study you join. You will receive the trial medicine, PF-08634404, usually as an infusion (a slow drip into a vein). If you are in a combination group, you will also receive standard chemotherapy drugs through a drip on set days.
If your cancer can be operated on, you will have your treatment before your operation. Doctors will carefully monitor your recovery and wound healing afterwards. If your cancer cannot be operated on, you will receive regular cycles of treatment for as long as it helps you.
Taking part involves regular visits to the hospital clinic. At these visits, doctors and nurses will check your general health, take blood and urine samples, and carry out imaging scans (such as CT or PET scans) to see how the tumour is responding. You may also have heart checks (ECGs). The total time you spend in the study can range from several months to a couple of years, including a follow-up period to keep track of your long-term health.
Potential risks and benefits
Locations (6)
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedIreland
- —UnverifiedGermany
- —UnverifiedPoland
Common questions
What is the main goal of this clinical trial?
The study aims to find out if the experimental drug PF-08634404 is safe, what side effects it causes, and how well it works alone or with chemotherapy to treat non-small cell lung cancer.
What does 'resectable' and 'unresectable' mean?
'Resectable' means a surgeon believes the tumour can be safely removed with an operation. 'Unresectable' means the tumour cannot be safely operated on, usually because of its position or how close it is to vital organs.
Will I have to pay to take part in the trial?
No. The trial medicine and all study-related tests are provided free of charge. Some studies also help with travel expenses to and from the hospital.
Can I leave the study if I change my mind?
Yes. You can leave the trial at any point without giving an explanation. Your medical team will simply discuss alternative treatment options with you.
How is the trial medicine given?
PF-08634404 and the chemotherapy drugs are given as an infusion into a vein (an intravenous drip) during scheduled visits to the hospital day unit.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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