A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
This study, called WU-KONG28, is looking for people aged 18 or over with advanced non-small cell lung cancer. Specifically, it's for those whose cancer has a particular change in a gene, called an EGFR Exon20ins mutation, and who haven't had previous treatment for their advanced cancer. The main aim is to compare a new drug, sunvozertinib, with standard chemotherapy (Pemetrexed plus carboplatin). Researchers want to find out which treatment is better at stopping the cancer from growing for a longer time, and which has fewer side effects. About 320 people will take part, with half receiving the new drug and half receiving chemotherapy.
At a glance
What is this study about?
This study is for individuals diagnosed with a type of lung cancer called non-small cell lung cancer that has either spread locally or to other parts of the body. What's particularly important for this study is that your cancer must have a specific genetic change, known as an EGFR Exon20ins mutation. This mutation means your cancer cells behave differently, and current standard treatments might not work as well. If you've just been diagnosed with advanced cancer and haven't started treatment yet, this study might be an option for you.
The main goal of this study is to compare a new treatment called sunvozertinib with a standard chemotherapy combination (Pemetrexed plus carboplatin). Researchers want to see if sunvozertinib can stop the cancer from growing for longer or shrink it more effectively than chemotherapy. They will also be closely watching for any side effects to understand how safe each treatment is. By comparing these two approaches, we hope to find a better first treatment option for people with this specific type of lung cancer.
About 320 people will join this study, and they will be randomly assigned to receive either sunvozertinib or the chemotherapy. This random assignment is like flipping a coin, ensuring that the comparison between the two treatments is fair. Doctors will regularly check how well the treatment is working and monitor your health throughout the study.
Key takeaways
- This study compares a new drug (sunvozertinib) with standard chemotherapy for advanced lung cancer.
- It's only for non-small cell lung cancer with a specific gene change (EGFR Exon20ins).
- Participants must be newly diagnosed with advanced cancer and not have had prior treatment for it.
- The study aims to find out which treatment is safer and more effective at controlling the cancer.
- About 320 people will take part, chosen randomly to receive one of the treatments.
- You will have regular checks, scans, and blood tests if you join the study.
Who may be eligible?
To be considered for this study, you must be at least 18 years old and have non-small cell lung cancer that has spread locally or to other parts of your body. A key requirement is that your cancer specifically has an EGFR Exon20ins gene mutation. This will be confirmed with a test on a sample of your cancer tissue. You also need to be someone who hasn't had any previous treatment for your advanced lung cancer.
Doctors will also check your general health, including your heart, kidneys, and blood, to make sure you are well enough to take part. You should also have a good level of activity in your daily life and a life expectancy of at least 12 weeks. Your cancer must also have at least one measurable area that doctors can track.
Even if you meet these points, you wouldn't be able to join if you've already had treatment for your advanced lung cancer, or if you have certain other EGFR gene mutations. People with recent strokes, certain severe uncontrolled health conditions, or spinal cord or brain lining cancer that has spread are also not suitable for this study.
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 or older?
- Do you have advanced non-small cell lung cancer?
- Has your cancer been tested and confirmed to have an EGFR Exon20ins mutation?
- Have you *not* had any previous treatment for your advanced lung cancer?
- Are you generally well and active enough for daily tasks?
- Do you have good kidney, liver, and blood test results?
What does participation involve?
If you join this study, you will be randomly assigned to one of two groups: either you will receive the new medicine, sunvozertinib, or you will receive the standard combination chemotherapy (Pemetrexed plus carboplatin). You will have regular visits to the clinic for medical examinations, blood tests, and scans (like CT scans) to see how you are responding to the treatment and to monitor for any side effects. These scans will help doctors measure if your cancer is shrinking or growing over time. The exact number of visits and tests will be explained in detail by the study team, but generally, you can expect frequent check-ups, especially at the start. The treatments will continue as long as they are working and you are tolerating them well, or until the study doctor decides it’s best to stop. After stopping treatment, there will be a follow-up period where your health will continue to be monitored.
Potential risks and benefits
Locations (158)
- OPN Healthcare, Inc.Verified postcodeGlendale, United States
- Kaiser Permanente Medical CenterVerified postcodeVallejo, United States
- University of Colorado Hospital - Anschutz Cancer PavilionVerified postcodeAurora, United States
- D&H Cancer Research Center LLCVerified postcodeMargate, United States
- BRCR Medical Center Inc.Verified postcodePlantation, United States
- NYU Laura & Issac Perlmutter Cancer Center at NYU Langone HealthVerified postcodeNew York, United States
- Columbia University Medical CenterVerified postcodeNew York, United States
- Gabrail Cancer Center ResearchVerified postcodeCanton, United States
- OSU Brain & Spine HospitalVerified postcodeColumbus, United States
- Providence Portland Institute FranzVerified postcodePortland, United States
- Texas Oncology - Baylor Charles A. Sammons Cancer CenterVerified postcodeDallas, United States
- The University of Texas MD Anderson cancer centerVerified postcodeHouston, United States
Common questions
What is non-small cell lung cancer?
It's the most common type of lung cancer. This study focuses on advanced cases where it's spread, and specific gene changes are present.
What is an EGFR Exon20ins mutation?
This is a specific change in a gene within your cancer cells. It helps doctors understand how your cancer might respond to certain treatments.
What does a 'Phase 3' study mean?
This means the new drug has already been tested in smaller groups of people and now researchers are comparing it directly against the best available standard treatment on a larger scale.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, which means both you and your study doctor will know whether you are receiving sunvozertinib or the standard chemotherapy.
What is the new drug, sunvozertinib?
Sunvozertinib is an investigational medicine being tested to see if it can specifically target and block the effects of the EGFR Exon20ins mutation in lung cancer cells.
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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