Active not recruitingPHASE3INTERVENTIONAL

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

This research study, called eVOLVE-Lung02, is for people with advanced non-small cell lung cancer that has spread to other parts of the body (metastatic). We want to find out if a new medicine called volrustomig, given with chemotherapy, works better and is safer than another common treatment, pembrolizumab, also given with chemotherapy. Both treatments are being tested as a first-time treatment for this type of cancer in patients whose cancer cells don't have a lot of a certain marker called PD-L1. Participants will be randomly assigned to one of the two treatment groups. Doctors will carefully monitor how well the treatments work and check for any side effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,200

Start

24 Oct 2023

Estimated completion

23 Mar 2029

Metastatic Non-small Cell Lung Cancer

What is this study about?

This study is looking into new ways to treat advanced non-small cell lung cancer. This is a common type of lung cancer where the disease has spread to other parts of the body. When lung cancer spreads, it's called metastatic. The goal of this study is to compare two different treatment approaches for patients who are just starting treatment for their metastatic non-small cell lung cancer.

The first treatment being looked at is a new medicine called volrustomig, given together with standard chemotherapy. The second treatment involves pembrolizumab, which is a well-known cancer drug, also given with standard chemotherapy. By comparing these two approaches, doctors hope to understand if volrustomig with chemotherapy can be a more effective or safer first treatment option for some patients.

Participants in the study will be split into two groups by chance, like flipping a coin, to receive one of these treatment combinations. Doctors will regularly check how the treatments are working by performing scans, and they will also closely monitor patients for any side effects. The study aims to find the best treatment to help patients live longer and feel better.

Key takeaways

This study is testing two main treatments for advanced lung cancer.
It's for people whose non-small cell lung cancer has spread.
The treatments involve new combinations of drugs plus chemotherapy.
You'll be randomly assigned to one of the treatment groups.
Regular check-ups and scans will be part of your participation.
You can leave the study at any time without affecting your medical care.

Who may be eligible?

This study is for adults who have been diagnosed with non-small cell lung cancer that has spread to other parts of the body. Your doctors will need to confirm the type of lung cancer you have, and that it's advanced and can't be cured by surgery or radiation yet.

To be considered, your cancer should not have certain gene changes (like EGFR, ALK, or ROS1 mutations) that would mean a different, already approved targeted therapy would be a better first choice for you. Your doctors will check for these. Also, if you have certain rare types of lung cancer, or a combination of small-cell and non-small cell lung cancer, you wouldn't be able to join.

There are also some health conditions that might prevent you from joining. For example, if you have severe spinal cord problems or serious, active brain tumours that are causing symptoms and need medication, you might not be suitable. If you’ve had another type of cancer in the last two years that wasn't fully cured, you might also not be able to participate. The study team will review your full medical history to see if this study is right for you.

Quick self-check

Do I have non-small cell lung cancer that has spread?
Has my doctor confirmed my cancer doesn't have certain specific gene changes (like EGFR, ALK, ROS1)?
Am I generally well enough to take part in a study?
Have I been free of other serious cancers for at least two years?
Do I have ongoing serious spinal cord problems or symptomatic brain tumours?

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

What does participation involve?

If you decide to join this study, you would be randomly assigned to one of two groups: one receiving volrustomig plus chemotherapy, and the other receiving pembrolizumab plus chemotherapy. This is like a lottery, and you won't get to choose which group you're in. The specific chemotherapy drugs will be either carboplatin and paclitaxel, or carboplatin and pemetrexed, depending on the type of your lung cancer.

You will have regular visits to the clinic for your treatments and check-ups. These visits will involve blood tests, physical examinations, and scans (like CT scans) to see how the treatment is affecting your cancer. These scans will continue until your doctors see that your cancer has grown. Even after that, you will continue to be monitored for how you are doing overall until the very end of the study, which could be for a long time.

Throughout the study, you'll be told what to expect at each appointment. You'll receive your study medications, and the medical team will keep a close eye on your health and any side effects.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving close medical attention and potentially new, effective treatments for your cancer. However, there's no guarantee that the treatments in this study will work better than standard care, or even work for you specifically. There's also a chance you could experience side effects from the study drugs, some of which might be serious. The medical team will explain all potential risks in detail before you decide to join. It's incredibly important to remember that participating is completely voluntary, and you can change your mind and withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (256)

Research Site
Prescott, United States
Research Site
Hot Springs, United States
Research Site
Springdale, United States
Research Site
Long Beach, United States
Research Site
Lone Tree, United States
Research Site
Fort Myers, United States
Research Site
Gainesville, United States
Research Site
Orlando, United States
Research Site
St. Petersburg, United States
Research Site
West Palm Beach, United States
Research Site
Fort Wayne, United States
Research Site
Indianapolis, United States

+244 more sites — see the official record for the full list.

Common questions

What is 'metastatic' lung cancer?

Metastatic means the cancer has spread from where it started in the lung to other parts of the body.

What is chemotherapy?

Chemotherapy uses strong medicines to kill cancer cells or slow their growth.

What does 'first-line treatment' mean?

It means this is the first set of treatments you would receive for your cancer after it's diagnosed as advanced.

Will I know which treatment I'm getting?

You will be randomly assigned to one of the two treatment groups, so you won't get to choose. Sometimes, in studies like this, you and your doctor will know which treatment you are on.

What is a 'clinical trial phase 3'?

Phase 3 trials are large studies that compare a new treatment to existing ones, often involving many people to confirm if a new treatment is better or safer before it can be widely approved.