A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection
This trial is testing a new targeted treatment called taletrectinib for people with non-small cell lung cancer. It is specifically for patients whose cancer has a rare genetic feature called a ROS1 fusion, and who have already had surgery to completely remove their tumour. Even after successful surgery, there is a chance microscopic cancer cells remain, which could cause the cancer to return. Researchers want to find out if taking taletrectinib daily can lower this risk and help people live longer, healthier lives compared to a dummy pill (placebo). This is a randomised, double-blind study. This means an equal computer draw decides whether you receive the real medicine or the placebo, and neither you nor your doctors will know which one you are taking. You will have regular clinic checks, scans, and blood tests to closely monitor your health.
At a glance
What is this study about?
Lung cancer is one of the most common cancers in the UK. Non-small cell lung cancer is the most frequent type. In a small number of people, the cancer cells have a fault in a gene called ROS1. This faulty gene acts like a broken switch, sending continuous signals that tell the cancer cells to grow and spread.
For early-stage lung cancer, the main treatment is often surgery to remove the tumour. While surgery can be very successful, doctors worry that tiny, invisible cancer cells might be left behind in the body. Over time, these cells can grow back. Finding treatments that prevent cancer from returning after surgery is an important goal in cancer research.
Taletrectinib is a new type of targeted drug designed to turn off the faulty ROS1 switch. By blocking these growth signals, scientists hope it will stop any leftover cancer cells from growing. This phase 3 study aims to confirm whether taletrectinib can keep patients cancer-free for longer compared to a placebo (an inactive dummy pill).
Key takeaways
- This trial is for adults who have had surgery to remove ROS1-positive non-small cell lung cancer.
- It tests whether a targeted pill called taletrectinib can stop the cancer from returning.
- Half of the participants will receive taletrectinib, and half will receive a dummy pill (placebo).
- You will receive regular health checks, blood tests, and scans to monitor your health.
- Taking part is voluntary, and you can withdraw at any time without losing standard medical care.
Who may be eligible?
You may be able to join this study if you are 18 or older and have been diagnosed with stage IB, II, or IIIA non-small cell lung cancer. Your tumour must have tested positive for the ROS1 gene change, and you must have already had surgery that completely removed the tumour.
You will need to be well enough to carry out everyday activities, and your surgery must have healed properly before starting.
You might not be able to take part if your cancer has spread to other distant parts of your body, if the tumour could not be fully removed during surgery, or if you have other serious medical conditions that would make taking part unsafe. The study doctor will review your full medical history to see if the trial is right 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 stage IB to IIIA non-small cell lung cancer.
- My tumour has been tested and is positive for the ROS1 gene alteration.
- I have had surgery to completely remove my lung tumour.
- I am generally well enough to manage my daily self-care and light activities.
What does participation involve?
If you take part, you will be randomly assigned to take either taletrectinib capsules or matching placebo capsules by mouth once a day. A computer makes this choice by chance, like flipping a coin. Neither you nor your hospital team will know which capsules you are receiving, though this can be quickly found out in an emergency.
You will visit the hospital clinic regularly for health checks. These visits will include physical examinations, blood and urine tests, heart traces (ECGs), and regular chest scans (such as CT or MRI scans) to check if your cancer has stayed away. The study team will also monitor any side effects you might experience. Treatment usually continues for a set number of years or until there is any sign that your cancer has returned, and the team will keep in touch to check on your long-term health.
Potential risks and benefits
Locations (5)
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedGermany
Common questions
What is a placebo and why is it used?
A placebo looks just like the real medicine but contains no active ingredients. It is used so researchers can be sure that any health improvements or side effects are truly caused by the study drug and not by chance.
Will I have to pay for the trial medication?
No. The study drug, tests, and any extra visits required for the research will be provided free of charge.
How do I know if my cancer has the ROS1 gene change?
Your hospital team usually tests tissue removed during your surgery for various gene changes. Your doctor can tell you if your tumour has been tested for ROS1.
Can I still have chemotherapy if I need it?
Standard care after surgery sometimes includes chemotherapy. The study team will explain how standard treatments fit into the trial timeline before you start taking the study capsules.
What happens if my cancer comes back during the trial?
Your regular scans will catch any changes early. If your cancer returns, the study treatment will stop, and your doctor will discuss other treatment options available to you on the NHS.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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