Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)
This study is investigating a new medication called taletrectinib. It's for people who have a certain type of lung cancer, called non-small cell lung cancer (NSCLC), where their cancer cells have a specific change in a gene called ROS1. You would have already had surgery to remove the lung tumour. The main goal is to find out if taletrectinib can help prevent the cancer from returning after surgery, compared to a dummy pill (placebo). This is a 'Phase 3' study, meaning it's a large trial to confirm the drug's effectiveness and safety. Participants won't know if they're receiving the drug or the placebo, and neither will their care team.
At a glance
What is this study about?
This research study, called TRUST-IV, is specifically designed for people in the UK who have been diagnosed with a type of lung cancer known as non-small cell lung cancer (NSCLC). Doctors have found that some lung cancers have specific changes in their genes. In this study, we're focusing on NSCLC that has a change in a gene called ROS1. This is important because medicines like taletrectinib are designed to target these specific changes.
You would have already had surgery to remove your lung tumour. The main question this study wants to answer is whether taking taletrectinib after surgery can help stop the cancer from coming back. To do this, some people will receive taletrectinib, and others will receive a placebo, which looks like the study drug but doesn't contain any active medicine. Comparing these two groups helps doctors understand if taletrectinib is truly effective.
Taking part in a study like this is a chance to potentially benefit from an investigational treatment. It also helps doctors learn more about how to treat NSCLC and improve care for future patients. All participants will be closely monitored by a medical team throughout the study.
Key takeaways
- This study is for a new drug, taletrectinib, for a specific type of lung cancer (ROS1-positive NSCLC).
- It aims to prevent cancer from returning after surgery.
- Participants will receive either the study drug or a placebo (dummy pill).
- Close medical monitoring and regular hospital visits are required.
- Participation is voluntary, and you can withdraw at any time.
- It's a 'Phase 3' study, which means it’s a larger trial to confirm effectiveness and safety.
Who may be eligible?
To be considered for this study, you would need to have specific types of non-small cell lung cancer (NSCLC) that your doctors have confirmed as Stage IB, II, or IIIA after surgery. Your cancer cells must also have a specific gene change called 'ROS1 rearrangement,' which will be checked by special tests.
You must have had surgery to remove your lung tumour, and doctors need to be sure that all the cancer was removed. You should have fully recovered from your surgery, which would have taken place between 4 and 16 weeks before joining, or up to 30 weeks if you also had chemotherapy after surgery. Any side effects from previous chemotherapy must have gone away or be very mild. You also need to be at least 18 years old and generally well enough to take part in the study activities.
There are also some reasons why you might not be able to join. For example, if you've already had radiation therapy for your current lung cancer after surgery, or if you're planning to have it. You also can't have received any other specific cancer treatments after your surgery that aren't part of 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.
- Do you have non-small cell lung cancer (NSCLC) confirmed as Stage IB, II, or IIIA?
- Has your cancer been tested and confirmed to be 'ROS1-positive'?
- Have you had surgery to remove your lung tumour, and all the cancer was removed?
- Are you fully recovered from your surgery?
- Are you at least 18 years old and generally feeling well?
- Have you not had radiation therapy for your lung cancer after surgery?
What does participation involve?
If you decide to take part in this study, you will be assigned to either receive the study drug (taletrectinib) or a dummy pill (placebo). You and your study doctor won't know which one you're receiving. You'll need to visit the clinic regularly for check-ups, which will include physical exams, blood tests, and scans to monitor your health and how the treatment is working. The exact number of visits and tests will be explained to you in detail by the study team.
You'll be taking the study medication or placebo at specific times as instructed by the study team. They will also keep track of any side effects you might experience. These close follow-up visits will continue for a certain period, and then you'll enter a longer-term follow-up phase where these checks might be less frequent. The total duration of your involvement in the study will be explained to you before you agree to participate.
Potential risks and benefits
Locations (33)
- UCLAVerified postcodeLos Angeles, United States· Recruiting
- UCI Chao Family Comprehensive Cancer CenterVerified postcodeOrange, United States· Recruiting
- Georgetown University Medical Cener (GUMC)Verified postcodeWashington D.C., United States· Recruiting
- Advent HealthVerified postcodeOrlando, United States· Recruiting
- Saint Alphonsus Health SystemVerified postcodeBoise, United States· Recruiting
- Tulane Cancer CenterVerified postcodeNew Orleans, United States· Recruiting
- Dana Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
- Mayo ClinicVerified postcodeRochester, United States· Recruiting
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Recruiting
- Sarah Cannon Research Institute (SCRI) - Texas Oncology-Central SouthVerified postcodeAustin, United States· Recruiting
- MD AndersonVerified postcodeHouston, United States· Recruiting
- Virginia Cancer SpecialistsVerified postcodeFairfax, United States· Recruiting
Common questions
What is ROS1-positive NSCLC?
It's a specific type of non-small cell lung cancer where the cancer cells have a particular change in a gene called ROS1. This change can be targeted by certain medicines.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study drug but doesn’t contain any active medicine. It helps researchers compare the effects of the actual drug.
Will I know if I'm getting the drug or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving taletrectinib or the placebo.
What if my cancer comes back during the study?
Your doctors will monitor you closely. If your cancer returns or gets worse, the study team will discuss appropriate treatment options with you, which may include stopping the study treatment.
How long will I be in the study?
The study involves a period of taking the treatment and regular check-ups, followed by a longer follow-up period. The exact duration will be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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