Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

This research study is looking at a new combination of two drugs, Tuvusertib and Cemiplimab, to treat a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC). This trial is for patients whose cancer has continued to grow even after receiving standard treatments like immunotherapy (anti-PD-(L)1 therapy) and platinum-based chemotherapy. The study will happen in two stages. Researchers want to find out how well this new combination works, if it's safe, how patients tolerate it, and how the body handles the drugs. It aims to offer a potential new option for patients who have limited choices after their initial treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrolment target

Start

13 Sep 2023

Estimated completion

30 Sep 2026

Non-Small Cell Lung Cancer

What is this study about?

This clinical trial is exploring a new treatment approach for non-small cell lung cancer (NSCLC), specifically the 'non-squamous' type. If you or someone you know has been diagnosed with this kind of lung cancer, you might be interested to know that this study is for individuals whose cancer has unfortunately progressed, meaning it has continued to grow, even after trying standard treatments. These standard treatments typically include a type of immunotherapy (drugs that help your body's immune system fight cancer, often called anti-PD-(L)1 therapy) and also platinum-based chemotherapy.

The study involves giving two medicines together: Tuvusertib and Cemiplimab. Tuvusertib is a new drug that works by blocking a specific protein in cancer cells, which might make cancer cells more vulnerable. Cemiplimab is an existing immunotherapy drug. By combining them, researchers hope to see if they can work better together than current options available to patients at this stage of their illness.

This trial is being conducted in two main phases. In the first phase, the focus is on safety and finding the right dose of the new combination. The second phase will then look at how effective the treatment is, and how well people tolerate it over a longer period. The ultimate goal is to find new, more effective ways to treat this type of lung cancer when standard therapies are no longer working as well.

Key takeaways

This study evaluates two drugs, Tuvusertib and Cemiplimab, for advanced non-squamous NSCLC.
It's for patients whose cancer has progressed after immunotherapy and platinum-based chemotherapy.
The trial aims to find out if this new combination is safe and effective.
Participation involves regular clinic visits, tests, and taking the study medications.
You will be closely monitored for treatment effects and side effects.
Joining is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to have non-squamous non-small cell lung cancer that has been confirmed by a doctor. Your cancer must also have grown or spread even after you've had certain specific treatments.

Specifically, you must have previously received one line of immunotherapy (like anti-PD-(L)1 therapy) and platinum-based chemotherapy for your advanced lung cancer. It's important that your cancer showed some positive response, like stable disease or shrinkage, to the immunotherapy at some point, but has since progressed. Your general health also needs to be good enough for you to participate, as assessed by the research team.

There are also some reasons why you might not be able to join. For example, if your cancer has specific genetic changes (like EGFR or ALK), you wouldn't be eligible. Also, if you've had another cancer recently (within the last 3 years), you generally wouldn't be able to join, unless it was a very common and less serious type of skin cancer.

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.

Do you have non-squamous non-small cell lung cancer?
Has your cancer grown or spread after receiving immunotherapy (like anti-PD-(L)1 therapy)?
Have you also received platinum-based chemotherapy for your advanced lung cancer?
Has your doctor confirmed that your overall health is good enough to participate in a study?
Are you aged 18 or over?
Do you not have specific genetic changes in your cancer (like EGFR or ALK)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study drugs, Tuvusertib and Cemiplimab. The study is 'open-label,' meaning both you and your doctors will know which treatments you are receiving. You'll have regular hospital visits for assessments, which will include blood tests, physical examinations, and scans (like X-rays or CT scans) to check how the treatment is working and monitor your health. How often these visits happen will vary, but they will be more frequent at the start of the study. You will continue to receive the treatment for as long as it is benefiting you and you are tolerating it well. After you stop receiving the study treatment, there will be follow-up appointments to monitor your health over time. The total duration of your participation will depend on how you respond to the treatment and the follow-up period, but clinical trials generally involve ongoing monitoring.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new treatments before they are widely available. While the specific benefits cannot be guaranteed, this combination therapy could potentially help control your cancer where previous treatments haven't. However, like all medications, the study drugs may cause side effects, some of which could be serious. The research team will monitor you closely for any side effects and will explain all known risks before you make a decision. Remember, participating in any clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (54)

UCLA Hematology and Oncology - Santa Monica
Verified postcode
Santa Monica, United States
UPMC Cancer Center
Verified postcode
Pittsburgh, United States
Tennessee Cancer Specialists - Biomedical Research
Verified postcode
Knoxville, United States
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States
Millennium Research & Clinical Development
Verified postcode
Houston, United States
Virginia Cancer Specialists, PC
Verified postcode
Fairfax, United States
Institut Jules Bordet - Department of Institut Jules Bordet'
Verified postcode
Anderlecht, Belgium
UZA - Oncology
Verified postcode
Edegem, Belgium
Jessa Ziekenhuis Hospital
Verified postcode
Hasselt, Belgium
Universitair Ziekenhuis Brussel - UZB
Verified postcode
Jette, Belgium
UZ Leuven
Verified postcode
Leuven, Belgium
CHU de Liège - PARENT
Verified postcode
Liège, Belgium

Common questions

What type of lung cancer is this study for?

This study is specifically for people with 'non-squamous non-small cell lung cancer' (NSCLC).

What are the new medicines being tested?

The study is testing a combination of two medicines called Tuvusertib and Cemiplimab.

Why is this study important?

It's important because it's looking for new treatment options for patients whose lung cancer has grown despite having tried standard immunotherapy and chemotherapy.

Will I know which treatment I am getting?

Yes, this study is 'open-label,' meaning both you and your doctors will know you are receiving the active study medications.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point without it affecting your medical care.