Active not recruitingPHASE2INTERVENTIONAL

Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer

This research study is looking at a new drug called acasunlimab, either by itself or combined with another cancer medicine called pembrolizumab. It's for people with a common type of lung cancer (non-small cell lung cancer) that has either returned after previous treatment or didn't respond to earlier treatments. The main goal is to understand how safe these treatments are and how well they work. The study has two parts: first, to find the right and safest doses, and then to test how effective the treatments are in more people. No one in this study will receive a placebo; everyone will get the active study drugs.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Genmab

Enrolment target

125

Start

27 Oct 2021

Estimated completion

30 Aug 2026

Non Small Cell Lung Cancer Metastatic

What is this study about?

This study is trying to find better ways to treat a common type of lung cancer called non-small cell lung cancer, especially when it has come back after treatment or hasn't responded to earlier care. Doctors are studying a new medicine called acasunlimab (also known as GEN1046). They want to see if it works well on its own or if it's better when given with another cancer drug called pembrolizumab. The main things they are looking for are how safe these treatments are for patients and how effective they are in fighting the cancer.

The study is split into two main parts. In the first part, a small group of people will help researchers figure out the safest doses for the combination of acasunlimab and pembrolizumab. Once they find these doses, the second part of the study will involve more people. In this bigger group, participants will be randomly assigned to receive either acasunlimab on its own or the combination of acasunlimab and pembrolizumab. This random assignment means it's like a coin toss; neither you nor your doctor chooses which specific treatment you get. This helps ensure the study results are fair and unbiased.

It's important to know that everyone in this study will receive active treatment. There won't be a 'placebo' group (a group receiving a dummy treatment). This means all participants will be actively receiving one of the study medications. The researchers hope that the findings from this study will help improve future treatments for non-small cell lung cancer.

Key takeaways

This study evaluates a new drug, acasunlimab, for returned or resistant non-small cell lung cancer.
It tests acasunlimab alone and in combination with another drug, pembrolizumab.
The main goals are to check safety and how well the treatments work.
All participants receive active study medication; no placebo is used.
The study involves regular visits and lasts about 10 months per person.
Eligibility depends on your specific cancer type, previous treatments, and overall health.

Who may be eligible?

To join this study, people generally need to be at least 18 years old and have been diagnosed with stage 4 non-small cell lung cancer that has spread. They must have already received at least one type of treatment for their cancer, which included a specific kind of immunotherapy. Doctors will also check that your general health is good enough for the study, including certain organ functions, and that your cancer can be measured.

There are certain reasons why someone might not be able to join. For example, if your cancer has specific genetic changes that would usually be treated with other targeted medicines, or if you've recently had other cancer treatments, including certain types of radiation or other experimental drugs. Also, if you have certain severe allergies to one of the study drugs (pembrolizumab) or a history of specific lung conditions that required steroid treatment, you might not be suitable.

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 stage 4 non-small cell lung cancer that has come back or not responded to treatment?
Have you already received at least one prior immunotherapy treatment for your cancer?
Is your general health good enough for clinical trial participation (e.g., organ function, fitness level)?
Have you discussed any potential genetic test results for your cancer with your doctor?
Are you able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the amount of time you'll be in the study will be about 10 months on average. During this time, you'll receive the study medication for about 6 months. Depending on which treatment group you're in, you'll get either acasunlimab by itself or acasunlimab with pembrolizumab. These medicines are given into a vein (like a drip) and will be administered every 3 or 6 weeks. Initially, you'll have weekly visits to the clinic, but as the study progresses, these visits will become less frequent, eventually spacing out to once every 3 weeks.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. You might benefit from receiving a new treatment that could help fight your cancer, especially if standard treatments haven't worked or your cancer has returned. However, there's no guarantee the treatment will work for you, and like all medicines, these drugs can have side effects. The study team will closely monitor you for any side effects and will explain all known risks. Remember, your participation is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (40)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

St. Joseph Heritage Healthcare
Verified postcode
Santa Rosa, United States
Florida Cancer Specialists - FCS South
Verified postcode
Fort Myers, United States
Florida Cancer Center
Verified postcode
St. Petersburg, United States
Henry Ford Cancer Institute
Verified postcode
Detroit, United States
Cancer & Hematology Centers of Western Michigan CHCWM P.C.
Verified postcode
Grand Rapids, United States
Medical College of Wisconsin
Verified postcode
Milwaukee, United States
Institut Bergonie
Verified postcode
Bordeaux, France
Hopital Morvan CHU de Brest
Verified postcode
Brest, France
Hopital Charles Nicolle Chu Rouen
Verified postcode
Rouen, France
Hopital dInstruction Des Armees Begin
Verified postcode
Saint-Mandé, France
Institut de Cancerologie Strasbourg Europe (ICANS)
Verified postcode
Strasbourg, France
Hôpital Foch
Verified postcode
Suresnes, France

Common questions

What kind of cancer is this study for?

It's for a common type of lung cancer called non-small cell lung cancer, specifically if it has come back or hasn't responded to previous treatments.

Will I get a dummy treatment (placebo)?

No, everyone in this study will receive the active study drugs, either acasunlimab alone or with pembrolizumab.

How long will I be in the study?

The study will last about 10 months for each person, with treatment given for about 6 months.

How often will I need to visit the clinic?

Initially, you'll have weekly visits, but these will become less frequent over time, eventually once every 3 weeks.

What are acasunlimab and pembrolizumab?

They are cancer medicines given into a vein. Acasunlimab is a new drug being tested, and pembrolizumab is another established cancer drug.