Active not recruitingPHASE3INTERVENTIONAL

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

This study is for people with a type of lung cancer called non-small cell lung cancer (NSCLC) that has a specific gene change (EGFR mutation). These patients have already tried and stopped responding to other targeted treatments. We want to see if a new drug, patritumab deruxtecan, is more effective and has fewer side effects than standard chemotherapy. The study will look at how long people live without their cancer growing and how long they live overall. This is an important step to find better treatments for this specific type of lung cancer when other options are no longer working well.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Daiichi Sankyo

Enrolment target

586

Start

08 Jul 2022

Estimated completion

30 Jun 2026

Nonsquamous Non-small Cell Lung Cancer EGFR L858R EGFR Exon 19 Deletion

What is this study about?

This study is called HERTHENA-Lung02 and it's looking into a new treatment for a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for people whose cancer has a particular change in a gene called EGFR (often referred to as an 'EGFR mutation'). These mutations are specific changes in the lung cancer cells that can make them grow. You might have been treated with certain targeted therapies that aim to block these specific changes, like osimertinib, but if your cancer has started to grow again, this study might be for you.

At the moment, if your cancer progresses after these targeted treatments, the usual next step is chemotherapy. However, chemotherapy can have a lot of side effects and might not always work as well as we'd like for this specific type of lung cancer. That's why researchers are looking for new and better options. This study wants to see if a new drug, patritumab deruxtecan, can be a more effective and gentle way to treat this cancer.

Patritumab deruxtecan is a new type of drug that's designed to deliver a powerful medicine directly to cancer cells while sparing healthy cells as much as possible. This study will compare it to the standard chemotherapy treatment to see which one works better at stopping the cancer from growing and helping people to live longer. This is a "Phase 3" study, which means it’s a big, very important step in seeing if this new drug could become a standard treatment in the future.

Key takeaways

This study evaluates a new treatment for advanced NSCLC with specific EGFR gene changes.
It's for patients whose cancer has progressed after prior targeted EGFR treatments.
The new drug, patritumab deruxtecan, is compared to standard chemotherapy.
The goal is to find a treatment that works better and is safer.
Participation involves regular hospital visits for infusions, tests, and monitoring.

Who may be eligible?

This study is open to both men and women aged 18 or older. To be considered, you need to have a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or is locally advanced (meaning it can't be fully removed with surgery or radiation). Your cancer must also have a specific gene change in the EGFR gene, such as an "exon 19 deletion" or "L858R" mutation, which would have been found when you were first diagnosed or since then.

You should have already received at least one, but no more than two, previous treatments for your advanced or spread lung cancer. One of these treatments must have been a "third-generation EGFR TKI" medicine, like osimertinib. Your cancer must have started to grow again while you were on this treatment, or shortly after, for you to qualify.

Also, your general health and fitness levels will be checked to make sure you can take part safely. This will include blood tests to check your organs and blood counts. You should feel well enough to carry out most daily activities. The study will also need to be able to measure your cancer on scans, and you'll need to be willing to provide a new small sample of your tumour (a biopsy) or existing tissue from a past biopsy.

Quick self-check

Are you 18 years old or older?
Do you have advanced or spread non-small cell lung cancer with an EGFR L858R or Exon 19 deletion mutation?
Has your cancer started growing again after you've already taken a third-generation targeted EGFR drug (like osimertinib)?
Have you had no more than two previous treatments for your advanced lung cancer?
Are you generally well and able to manage most daily activities?
Do your doctors think your cancer can be measured on scans?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be randomly assigned to receive either the new drug, patritumab deruxtecan, or standard platinum-based chemotherapy. This means you won't get to choose which treatment you receive, similar to flipping a coin. You will receive your assigned treatment in cycles, usually through an intravenous drip. You'll have regular hospital visits for infusions, check-ups, blood tests, and scans to monitor your health and how the treatment is working.

These visits will happen frequently at first, then less often as treatment continues. The treatment will continue for as long as it is benefiting you and you are tolerating it well. You'll also have follow-up appointments after you finish treatment to monitor your health and collect information on your progress. The total length of your participation will vary depending on how long your treatment lasts and the follow-up, but generally, studies like this involve regular contact for many months or even a few years.

Potential risks and benefits

Patients in this study might benefit from a new treatment that could be more effective and better tolerated than current options, potentially helping to control their cancer for longer or improving their quality of life. However, like all medicines, the new drug and the chemotherapy treatments may cause side effects, which can vary from mild to severe, and could include things like feeling sick, tiredness, or changes in blood counts. Your study doctor and nurse will carefully monitor you for any side effects and help manage them. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (182)

Alaska Oncology and Hematology LLC
Anchorage, United States
Highlands Oncology
Springdale, United States
City of Hope
Duarte, United States
Moores Cancer Center at the UC San Diego Health
La Jolla, United States
Scripps MD Anderson Cancer Center
La Jolla, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
Kaiser Permanente - Vallejo Medical Center
Vallejo, United States
Innovative Clinical Research Institute
Whittier, United States
Sarah Cannon/Florida Cancer Specialists - FCS South
Port Charlotte, United States
Emory University
Atlanta, United States
St Luke's Cancer Institute
Boise, United States
American Oncology Partners of Maryland
Bethesda, United States

+170 more sites — see the official record for the full list.

Common questions

What type of lung cancer is this study for?

It's for non-small cell lung cancer (NSCLC) that has spread or is advanced, and has a specific EGFR gene change.

What does 'EGFR mutation' mean?

It means your cancer cells have a particular change in the EGFR gene that can make them grow, which your doctors will have tested for.

What if my cancer is growing even after my current treatment?

This study is specifically for people whose cancer has progressed after taking a targeted EGFR treatment like osimertinib.

Will I get the new drug or chemotherapy?

You will be randomly assigned to one or the other, like drawing lots, so you won't get to choose.

What is the new drug supposed to do?

It's designed to deliver medicine directly to the cancer cells to stop them growing, hopefully with fewer side effects than traditional chemotherapy.