Active not recruitingPHASE2INTERVENTIONAL

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

This research study, called HERTHENA-Lung01, is testing a new medicine named patritumab deruxtecan for people with advanced non-small cell lung cancer. This cancer must have a particular genetic change, known as an EGFR mutation. The study is for patients whose cancer has come back or worsened after they've already received an EGFR-targeting medicine and chemotherapy. The main goal is to see how well patritumab deruxtecan works against the cancer. Participants will be randomly assigned to receive the medicine in one of two ways: either a standard amount or a gradually increasing amount. This helps researchers understand the best way to give the treatment and if it can shrink tumours.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Daiichi Sankyo

Enrolment target

277

Start

02 Feb 2021

Estimated completion

03 Jul 2026

Non-Small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor

Results

Results from this study

Posted April 2024

Results have been published for this study.

Primary outcome

Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)

ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.

Full results on the registry

What is this study about?

This study is for people in the UK who have a type of lung cancer called non-small cell lung cancer. Specifically, it's for those whose cancer has spread (metastatic) or is advanced locally and cannot be cured by surgery or radiation. Doctors have found a specific genetic change in their cancer, called an EGFR mutation (either 'exon 19 deletion' or 'L858R').

The study is looking at a new medicine called patritumab deruxtecan. This medicine is designed to target cancer cells that have the EGFR mutation. It's for patients who have already tried and are no longer responding to at least one EGFR-targeting medicine (like osimertinib) and at least one type of chemotherapy that includes a platinum-based drug. The research aims to see if patritumab deruxtecan can help shrink tumours or stop the cancer from growing.

Participants will be split into two groups by chance (like flipping a coin). One group will receive a set dose of patritumab deruxtecan, and the other group will start with a smaller dose that slowly increases. This helps the researchers find the most effective and safest way to give the new medicine. It's an important step in developing new treatments for this specific type of lung cancer.

Key takeaways

This study is for advanced non-small cell lung cancer with a specific EGFR genetic change.
It's for patients who have already received an EGFR-targeting drug and chemotherapy.
The study tests a new medicine called patritumab deruxtecan.
Participants will be randomly assigned to different dosing approaches.
The goal is to see if the new medicine can shrink tumours or stop cancer growth.

Who may be eligible?

To join this study, you would need to be at least 18 years old. Your non-small cell lung cancer must be advanced or have spread, and doctors must have found a specific change in the cancer's genes called an EGFR mutation (either 'exon 19 deletion' or 'L858R').

It's important that your cancer has previously been treated with at least one EGFR-targeting medicine (like gefitinib, erlotinib, or osimertinib) and at least one chemotherapy treatment that included a platinum-based drug. The cancer must have shown signs of growing or getting worse since your last treatment. You would also need to have at least one spot on your body where the cancer can be easily measured by scans.

You would also need to be willing to provide a recent tumour tissue sample, or one that was taken previously, for analysis. This is to confirm the type of cancer and its genetic makeup. Your study doctor will check all these points carefully to see if this study 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.

Are you at least 18 years old?
Do you have advanced non-small cell lung cancer with an EGFR mutation?
Has your cancer progressed on or after an EGFR-targeting drug and platinum-based chemotherapy?
Are you able to provide a recent or existing tumour tissue sample?
Do you have at least one measurable cancer spot on your scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first sign consent forms after discussing the study thoroughly with the medical team. You would undergo several tests, including blood tests, scans, and potentially a new tumour biopsy if a suitable existing tissue sample isn't available. These tests help ensure you meet all the study requirements and are healthy enough to participate.

Once enrolled, you would receive the study medication, patritumab deruxtecan, given through a drip (intravenously) at regular intervals. You would have regular appointments for check-ups, blood tests, and scans to monitor how the treatment is working and to check for any side effects. These visits would continue for as long as you are on the treatment and show benefit. After stopping the treatment, there would also be follow-up visits to monitor your health. The total time you might spend in the study will depend on how you respond to the treatment, but monitoring for safety and effectiveness is ongoing.

Potential risks and benefits

Participating in a clinical trial may offer benefits, such as receiving a new investigational treatment that might help with your cancer when other treatments have stopped working. You would also be closely monitored by a specialised medical team. However, there are also potential risks. Like all medicines, patritumab deruxtecan may cause side effects, which can vary from mild to serious, and some may be unknown. The treatment might not work for you, or it might not work as well as expected. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (123)

Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
City of Hope
Verified postcode
Duarte, United States
Moores Cancer Center at the UC San Diego Health
Verified postcode
La Jolla, United States
Pacific Shores Medical Group
Verified postcode
Long Beach, United States
USC Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States
University of California at Irvine
Verified postcode
Orange, United States
Cedars Sinai
Verified postcode
West Hollywood, United States
University of Colorado Denver - Anschutz Medical Campus
Verified postcode
Aurora, United States
Florida Cancer Specialists - South
Verified postcode
Fort Myers, United States
AdventHealth Orlando
Verified postcode
Orlando, United States
Memorial Healthcare System
Verified postcode
Pembroke Pines, United States
Florida Cancer Specialist-North
Verified postcode
St. Petersburg, United States

Common questions

What is an EGFR mutation?

An EGFR mutation is a specific change in the genes of some lung cancer cells that can make them grow more quickly. This study focuses on two common types of these changes.

What does 'metastatic' or 'locally advanced' mean?

Metastatic means the cancer has spread to other parts of the body. Locally advanced means the cancer has grown to nearby tissues and may be too big or spread too far to be removed with surgery or radiation alone.

What is patritumab deruxtecan?

It's a new investigational drug being tested as a treatment for certain types of lung cancer. It's designed to specifically target cancer cells.

Why do I need to have tried other treatments first?

This study is designed for people whose cancer has not responded well to standard treatments that are usually given first for this type of lung cancer. This helps researchers understand how effective the new drug is when other options are no longer working.

Will I know which dose of the medicine I am getting?

Initially, you will be randomly assigned to one of two groups, receiving either a fixed dose or a dose that gradually increases. You and your doctor might not know which specific group you are in, as this helps ensure the study results are unbiased.