Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
This study is looking for adults with a type of lung cancer called non-small cell lung cancer that has spread to other parts of the body. Participants must have already tried and stopped responding to a type of treatment called an immune checkpoint inhibitor. The aim is to see if a new vaccine, OSE2101, is more effective than a standard chemotherapy drug called Docetaxel. Patients will be split into two groups by chance: one group receives OSE2101, and the other receives Docetaxel. Doctors will closely monitor everyone to see how well the treatments work. The ultimate goal is to find better treatment options for people living with this type of lung cancer.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned research study involving people. Its main purpose is to test a new treatment called OSE2101 for people with a specific type of lung cancer. This cancer is called non-small cell lung cancer (often shortened to NSCLC), and the study is focused on those whose cancer has spread and who have already been treated with certain immune-boosting drugs (called immune checkpoint inhibitors) but their cancer is no longer responding to them.
Researchers want to see if OSE2101 can help people whose cancer has become resistant to their previous immune treatments. They will compare OSE2101 against a standard chemotherapy treatment called Docetaxel. By doing this, they hope to find out if OSE2101 can be a better option for these patients, potentially slowing down the cancer's growth or improving quality of life.
This is a 'Phase 3' study, which means it's one of the final steps before a new treatment can be widely approved. It involves many hospitals and clinics, and patients will be randomly assigned to receive either OSE2101 or Docetaxel, like flipping a coin, to ensure a fair comparison. This helps make sure the results are reliable and can truly show which treatment is more effective.
Key takeaways
- This study is for advanced lung cancer (NSCLC) that no longer responds to immune checkpoint inhibitors.
- It tests a new vaccine (OSE2101) against standard chemotherapy (Docetaxel).
- Participation involves strict eligibility, including a specific genetic marker (HLA-A2).
- You'll be randomly assigned to one of the two treatment groups.
- The goal is to find better treatment options for people with this type of lung cancer.
- Discuss all aspects with your doctor before deciding to participate.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. You must have a type of lung cancer called non-small cell lung cancer that has spread (metastatic). Importantly, your cancer must also have stopped responding to previous treatment with a type of drug known as an immune checkpoint inhibitor. The study will also check specific genetic markers in your blood, called HLA-A2.
Your cancer must not be suitable for surgery or radiation that would cure it. Also, if your cancer has certain specific genetic changes (like EGFR, ALK, or ROS1), you generally wouldn't be able to join if there are targeted treatments available for those changes. However, there might be exceptions for other genetic changes, like KRAS G12C and BRAF, depending on what treatments are available where you live and after discussion with the study sponsors.
There are other requirements and reasons why someone might not be able to join, which the study doctors will explain fully. These are in place to make sure the study is safe for participants and that the results are clear.
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 at least 18 years old?
- Do you have non-small cell lung cancer that has spread?
- Has your cancer stopped responding to a type of immune system treatment?
- Do you have the HLA-A2 genetic marker (this will be tested)?
- Does your lung cancer not involve specific genetic changes like EGFR, ALK, or ROS1 for which targeted treatments are available?
What does participation involve?
If you join this study, you'll be randomly assigned to one of two groups: one will receive the new treatment OSE2101, and the other will receive Docetaxel, a standard chemotherapy. You won't get to choose which treatment you receive. Your participation will involve regular visits to the clinic for medical check-ups, blood tests, and scans to see how your body is responding to the treatment and whether the cancer is changing.
You will receive your assigned medication on a set schedule. Doctors and nurses will closely monitor any side effects you might experience. There will also be follow-up appointments after your main treatment period to keep an eye on your health and the long-term effects of the treatment. The total duration of your participation will depend on how you respond to the treatment and the study plan, but your doctor can give you more specific details.
Potential risks and benefits
Locations (207)
- Clinical Research Advisors, LLCVerified postcodeBeverly Hills, United States· Recruiting
- Clinical Research Advisors - EncinoVerified postcodeEncino, United States· Active not recruiting
- Clinical Research Advisors - West HollywoodVerified postcodeLos Angeles, United States· Active not recruiting
- Clinical Research Advisors - Korea TownVerified postcodeLos Angeles, United States· Active not recruiting
- SCL Health - Saint Joseph Hospital Cancer CenterVerified postcodeLittleton, United States· Withdrawn
- Lutheran Medical Center - Cancer Centers of ColoradoVerified postcodeWheat Ridge, United States· Recruiting
- Eastern Connecticut Hematology and Oncology AssociatesVerified postcodeNorwich, United States· Recruiting
- Georgetown Lombardi Comprehensive Cancer CenterVerified postcodeWashington D.C., United States· Recruiting
- Comprehensive Hematology Oncology - Bradenton ClinicVerified postcodeBradenton, United States· Active not recruiting
- Comprehensive Hematology Oncology - Brandon ClinicVerified postcodeBrandon, United States· Active not recruiting
- Cancer Specialists of North Florida - Fleming IslandVerified postcodeFleming Island, United States· Recruiting
- Cancer Specialists of North Florida - RiversideVerified postcodeJacksonville, United States· Active not recruiting
Common questions
What is an immune checkpoint inhibitor?
These are drugs that help your body's immune system recognise and fight cancer cells. They 'take the brakes off' your immune system.
What does 'secondary resistance' mean?
It means your cancer initially responded to a treatment, but over time, it stopped responding and started to grow again.
What is the new vaccine OSE2101?
OSE2101 is an investigational vaccine designed to help your immune system recognise and attack lung cancer cells more effectively.
What is Docetaxel?
Docetaxel is a type of chemotherapy drug commonly used to treat various cancers, including lung cancer, by stopping cancer cells from growing.
What does 'randomized 2:1' mean?
It means for every three people who join, two will be chosen by chance to receive OSE2101, and one will be chosen by chance to receive Docetaxel.
How to find out more
Caroline Chevalier, MSc, MPH
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.