Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A RANDOMIZED, PHASE 2, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY OF DOSTARLIMAB PLUS CHEMOTHERAPY VERSUS PEMBROLIZUMAB PLUS CHEMOTHERAPY IN METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

This research is investigating new ways to treat non-small cell lung cancer that has spread to other parts of the body. The study aims to compare two different treatment plans: one combines a drug called dostarlimab with standard chemotherapy, and the other uses pembrolizumab with chemotherapy. Doctors want to find out if one combination is more effective at shrinking tumours and improving how long people live with the disease. This type of study, known as a Phase 2 trial, helps researchers understand if these new treatments are promising enough to be studied in larger groups of patients. It's a crucial step in developing better options for people with this kind of lung cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

114

Start

16 Feb 2024

Lung Cancer Non-Small Cell

What is this study about?

This study is focusing on a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread in the body. When cancer spreads, it's called 'metastatic'. Doctors are always looking for better ways to treat this condition to help patients live longer and improve their quality of life. This trial is comparing two different treatment approaches to see which one works best. Both approaches involve chemotherapy, which is a standard cancer treatment, combined with a newer type of drug. The drugs being tested are called dostarlimab and pembrolizumab. Both of these drugs are types of 'immunotherapy', which work by helping your body's own immune system fight cancer cells.

The main goal of this study is to see how well these two treatment combinations shrink tumours. Doctors will measure the size of the tumours over time to see if they get smaller or disappear. They will also look at how long people live and how long they live without their cancer growing worse. By carefully comparing these two treatment plans, researchers hope to find out if one is more effective or has different benefits than the other. This information is vital for deciding which treatments should be used in the future.

This is a 'Phase 2' study, which means it's an earlier stage of research. It's designed to gather more information about how safe and effective these treatments are before they are potentially tested in much larger groups of people. Finding better and safer treatments for NSCLC that has spread is very important, as it could offer new hope and improved outcomes for patients.

Key takeaways

This study compares two new drug combinations for metastatic non-small cell lung cancer.
Both combinations include standard chemotherapy plus an immunotherapy drug.
The aim is to find out which treatment is better at shrinking tumours and extending life.
Participants will receive one of the two treatments by chance, and neither they nor their doctors will know which one.
Close monitoring for effectiveness and side effects will be part of the study.
It's a Phase 2 trial, an early step in finding better cancer treatments.

Who may be eligible?

To join this study, people need to be at least 18 years old. Both men and women can take part. The study is specifically for individuals who have non-small cell lung cancer that has spread to other parts of the body.

There will also be other health checks to make sure the treatment is safe for you. For example, doctors will review your general health, your lung cancer history, and any other medical conditions you might have. This is to ensure that the study treatments are appropriate for your specific situation.

It's important to remember that exact details about who can and cannot join are very specific to each study. Your doctor or the study team will be able to tell you if you meet all the criteria.

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 18 years old or older?
Do you have non-small cell lung cancer that has spread?
Are you able to attend regular clinic appointments and tests?
Are you generally well enough to start a new cancer treatment?
Are you able to follow the study's specific treatment plan?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of two treatment combinations: either dostarlimab plus chemotherapy, or pembrolizumab plus chemotherapy. This choice is made at random, like flipping a coin, so neither you nor your doctor can choose which one you get. You also won't know which specific combination you're receiving (this is called 'double-blind').

You would have regular visits to the clinic for your treatments and to have various tests. These tests include blood and urine samples, checks of your heart and vital signs (like blood pressure), physical examinations, and scans to see how your cancer is responding. The study team will also keep track of any side effects you might experience.

The treatments would continue for a certain period, and even after your last dose, you might have follow-up visits or contact to monitor your health. The total time you would be involved in the study can vary depending on your individual response to treatment, but the full duration, including follow-up, will be explained to you by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer you access to new treatments before they are widely available. Your health will be closely monitored, and you will receive regular medical care and attention. However, there are also potential risks, as new treatments can have side effects that aren't fully known, and there's no guarantee the treatment will work for you. Some side effects can be uncomfortable or serious. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Germany
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Unverified
Romania
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Unverified
Italy
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Unverified
France
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Unverified
Spain
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Unverified
Poland

Common questions

What is 'non-small cell lung cancer'?

It's the most common type of lung cancer. This study focuses on cases where it has spread in the body.

What is chemotherapy?

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

What are dostarlimab and pembrolizumab?

These are immunotherapy drugs that help your body's immune system recognise and fight cancer cells.

What does 'double-blind' mean?

It means neither you nor your doctor will know which specific treatment combination you are receiving in the study.

Can I choose which treatment I get?

No, within this study, the choice between the two treatment combinations is made randomly, like drawing lots.