HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFR mutated Non-Small Cell Lung Cancer (NSCLC)
This clinical trial is testing an experimental medicine called patritumab deruxtecan in adults with non-small cell lung cancer. It is specifically for patients whose cancer has spread (advanced or metastatic) and carries a particular gene change known as an EGFR mutation. While targeted medicines can work well at first for this type of cancer, the cells often find ways to resist treatment over time. When standard therapies stop working, new treatment options are urgently needed. Patritumab deruxtecan is designed to act like a guided missile, finding cancer cells and delivering medicine directly inside them. The main aim of this Phase 2 study is to find out how well the drug shrinks tumours, how long it keeps the cancer under control, and what side effects it may cause. This helps doctors learn if it could become a helpful future treatment option.
At a glance
What is this study about?
Non-small cell lung cancer is the most common type of lung cancer. In some people, the cancer cells have a fault in a gene called EGFR, which tells the cells to grow and divide. Doctors usually treat this with targeted medicines. However, over time, the cancer often changes and finds ways around these medicines, causing the tumours to grow again. When standard treatments stop working, doctors need new, effective ways to tackle the disease.
This study, called HERTHENA-Lung01, is testing an experimental drug called patritumab deruxtecan. It belongs to a modern group of cancer medicines called antibody-drug conjugates. You can think of it like a smart delivery vehicle: one part attaches specifically to a protein found on the cancer cells, while the other part releases a strong cancer-fighting medicine directly inside the cell. The goal is to destroy the cancer while causing as little damage to healthy cells as possible.
Researchers want to see how many patients experience tumour shrinkage with this treatment, and how long those benefits last. They are also measuring how long the treatment keeps the cancer from getting worse and tracking general health and survival. Gathering this information helps doctors understand whether the new drug is both safe and effective enough to be considered for wider use in the future.
Key takeaways
- Tests a new targeted medicine (patritumab deruxtecan) for advanced non-small cell lung cancer.
- Aimed at adults whose cancer has an EGFR gene change and has stopped responding to prior therapies.
- The drug acts like a smart delivery system to target cancer cells directly.
- Involves regular hospital visits for infusions, blood tests, and scans.
- Participation is completely voluntary, and you may leave the study at any point.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with advanced or metastatic non-small cell lung cancer. "Advanced" or "metastatic" means the cancer has spread into surrounding tissues or to other parts of the body.
To be considered, your cancer must have tested positive for a specific genetic change known as an EGFR mutation. Additionally, you must have already tried standard treatments for this cancer that have either stopped working or are no longer suitable for you.
Before taking part, the hospital team will run standard health checks, such as blood tests and scans, to make sure your heart, kidneys, and liver are working well enough for you to safely receive the study medicine.
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 advanced or metastatic non-small cell lung cancer.
- My cancer has a confirmed EGFR gene mutation.
- I have previously received standard lung cancer treatments that are no longer working.
- I am well enough to attend regular hospital appointments for treatment and monitoring.
What does participation involve?
If you join the study, you will receive patritumab deruxtecan as a drip directly into a vein (an intravenous infusion) at the hospital on a regular schedule. During your visits, you will have routine health checks, including physical exams, blood tests, and heart tracings (ECGs). You will also have regular imaging scans, such as CT or MRI scans, to see how your cancer is responding to the treatment. You can usually remain on the study drug for as long as it continues to help you and any side effects remain manageable. Afterwards, the study team will keep in touch to check on your health and wellbeing.
Potential risks and benefits
Locations (6)
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedSpain
Common questions
What is an EGFR mutation?
It is an abnormal change in the DNA of your cancer cells that makes them grow. It is not an inherited fault that you can pass on to your children.
What is a Phase 2 trial?
A Phase 2 study tests how well a drug works against a specific condition and continues to check its safety in a group of several dozen to several hundred patients.
Will I receive a dummy treatment (placebo)?
No. This is an open-label study, meaning every person who takes part receives the active study medicine, and both you and your doctor know what you are receiving.
Do I have to pay to take part?
No, the study medicine and any extra trial-related tests are provided free of charge, and some travel expenses may be covered.
Can I leave the trial if I change my mind?
Yes. You have the right to withdraw from the trial at any time, for any reason, and your usual NHS care will continue as normal.
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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