ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
This research study, called a Phase 3 clinical trial, is investigating a new medication named gotistobart (also known as ONC-392 or BNT316) for people with advanced non-small cell lung cancer. This is for patients whose cancer has unfortunately progressed even after receiving treatment with PD-1/PD-L1 drugs. The main goal is to find out if gotistobart is safe and more effective than a standard chemotherapy drug called docetaxel in helping patients live longer. Participants will be randomly assigned to receive either gotistobart or docetaxel through an IV drip every three weeks for up to about one year. This study aims to offer a new treatment option for this type of lung cancer.
At a glance
What is this study about?
This clinical trial is looking into a new treatment called gotistobart for a type of lung cancer known as non-small cell lung cancer (NSCLC). This study is for people whose cancer has spread and has not responded well to, or has worsened after, previous treatments that targeted PD-1 or PD-L1 proteins. Scientists want to see if gotistobart can be a better option than a common chemotherapy drug called docetaxel.
Think of this study as a careful comparison. We know that docetaxel is a standard treatment, but researchers are hoping gotistobart might offer more benefits. By comparing the two, they can learn if gotistobart is safe and if it can help people live longer or improve their quality of life. This is a "Phase 3" trial, which means it's one of the final steps before a new drug might become widely available, if it proves successful.
Around 630 people will take part in this study. In the first part, different doses of gotistobart will be tested to find the best one. Then, in the second part, that chosen dose of gotistobart will be directly compared to docetaxel. This careful approach helps ensure that the safest and most effective treatment is identified. Your participation could help advance our understanding and treatment of non-small cell lung cancer.
Key takeaways
- New drug (gotistobart) versus standard chemotherapy (docetaxel) for advanced lung cancer.
- For patients whose non-small cell lung cancer worsened after previous immunotherapy.
- Treatment is given by IV drip every three weeks for up to about one year.
- Aims to see if gotistobart can help patients live longer.
- Around 630 patients will be randomly assigned to one of the two treatment groups.
Who may be eligible?
To join this study, you need to be an adult aged 18 or older with a confirmed diagnosis of advanced non-small cell lung cancer that has spread. Your cancer must have worsened even after you've had certain treatments that included PD-1/PD-L1 drugs. You also need to be generally well enough to take part, with a good level of physical activity and healthy organ function. The doctors will also need to be able to measure at least one of your tumours using scans.
There are some reasons why you might not be able to join. For example, if you have had certain cancer treatments very recently, or if side effects from previous treatments haven't fully cleared up. You also can't have certain other health conditions like serious heart problems, active infections needing strong antibiotics, or some types of stomach or lung diseases. If your cancer has certain specific gene changes (mutations) or if it has spread to your brain causing symptoms, you might not be able to participate.
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 advanced non-small cell lung cancer that has spread?
- Has your cancer worsened after receiving PD-1 or PD-L1 based immunotherapy?
- Are you generally well enough for active treatment (ECOG score 0 or 1)?
- Have you discussed any recent infections or other serious health conditions with your doctor?
- Do you have symptomatic brain metastases or certain specific genetic changes in your cancer (excluding KRAS)? (If yes, you may not be eligible)
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to one of two groups: one receiving the new drug, gotistobart, and the other receiving docetaxel chemotherapy. Neither you nor your doctor will get to choose which group you are in, and it's a bit like flipping a coin for fairness. Both treatments are given through a drip into your vein. You'll receive this treatment every 21 days (every three weeks) for up to approximately one year (17 cycles).
Throughout the study, you'll have regular hospital visits. These visits will include various tests such as blood tests, scans (like X-rays or CT scans) to check your cancer, and discussions with the study team to monitor your health and any side effects. The study team will explain all the details of these visits and tests before you agree to take part. The total length of your treatment will be about one year, but you'll have follow-up checks even after your treatment ends to see how you're doing long-term.
Potential risks and benefits
Locations (152)
- XCancer/Dothan Hematology & Oncology - 1114Verified postcodeDothan, United States· Recruiting
- Genesis Cancer and Blood Institute - 1123Verified postcodeRussellville, United States· Recruiting
- The Oncology Institute (TOI) Clinical Research - 1109Verified postcodeCerritos, United States· Recruiting
- Emad Ibrahim MD Inc. - 1147Verified postcodeRedlands, United States· Recruiting
- UC Davis Comprehensive Cancer Center - 1103Verified postcodeSacramento, United States· Recruiting
- Bass Medical Group - 1155Verified postcodeWalnut Creek, United States· Recruiting
- Nuvance Health - 1118Verified postcodeNorwalk, United States· Recruiting
- D&H Cancer Research Center LLC - 1153Verified postcodeMargate, United States· Recruiting
- Ocala Oncology Center PL - 1102Verified postcodeOcala, United States· Recruiting
- AdventHealth Cancer Institute - 1105Verified postcodeOrlando, United States· Recruiting
- Orlando Health - 1130Verified postcodeOrlando, United States· Recruiting
- Florida Cancer Specialists -South - 1126Verified postcodeSarasota, United States· Recruiting
Common questions
What is Non-Small Cell Lung Cancer (NSCLC)?
It's the most common type of lung cancer. This study is for people whose NSCLC has spread and worsened after certain previous treatments.
What are PD-1/PD-L1 inhibitors?
These are a type of immunotherapy that helps your body's immune system fight cancer. This study is for people whose cancer progressed despite these treatments.
What's the difference between gotistobart and docetaxel?
Gotistobart is a new investigational drug being tested, while docetaxel is a standard chemotherapy drug often used for lung cancer. The study is comparing them.
How many people will be in this study?
About 630 people will take part in this study. Participants will be randomly placed into one of the treatment groups.
What does 'randomized' mean?
It means you'll be assigned to either the gotistobart group or the docetaxel group by chance, like drawing names from a hat. This ensures a fair comparison.
How to find out more
Pan Zheng, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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