Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer

This research study is for people with advanced non-small cell lung cancer who haven't had treatment for it before. The study aims to look at new ways to treat this type of cancer. It’s comparing two different treatment combinations: a new drug called vudalimab combined with standard chemotherapy, or an existing drug called pembrolizumab (also known as KEYTRUDA) combined with standard chemotherapy. The main goals are to see how safe these new treatment approaches are (checking for side effects) and how well they work at stopping the cancer from growing or shrinking it. This is a clinical trial to find better treatment options for patients.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Xencor Inc.

Enrolment target

116

Start

21 May 2024

Advanced Non-small Cell Lung Cancer

What is this study about?

This study is a clinical trial looking at new ways to treat advanced non-small cell lung cancer, which is a type of lung cancer that has spread to other parts of the body. If you have this type of cancer and haven't had treatment for it yet, this study might be for you. The researchers want to find out if combining certain new medicines with standard chemotherapy can be more effective than current treatments.

The study is divided into two main parts. In the first part, the researchers will mainly be checking how safe these new drug combinations are and carefully monitoring for any side effects. This helps them understand the best and safest doses to use. In the second part, once the doses are set, the main goal is to see how well the treatments work. They'll be looking at how long people live without their cancer getting worse, and also checking how many people see their cancer shrink or disappear a bit.

This kind of research is really important because it helps doctors develop better treatments for life-limiting illnesses like advanced non-small cell lung cancer. By understanding how these new combinations work, both in terms of safety and effectiveness, the hope is to improve the lives of patients in the future. Participation in studies like this contributes greatly to medical progress.

Key takeaways

Tests new drug combinations for advanced non-small cell lung cancer.
Compares vudalimab + chemotherapy vs. pembrolizumab + chemotherapy.
Aims to check safety and how well treatments work.
For patients who haven't had previous treatment for advanced disease.
Involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To join this study, people generally need to be 18 years old or older. Both men and women can take part. The study is specifically for individuals who have been diagnosed with advanced non-small cell lung cancer. It's important that you haven't received any treatment for this advanced cancer before, as the study is looking at first-time treatments.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with advanced non-small cell lung cancer?
Have you NOT received any prior treatment for your advanced lung cancer?
Are you able to attend regular hospital appointments?

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

What does participation involve?

If you decide to take part in this study, you might receive one of two treatment combinations: either vudalimab plus chemotherapy, or pembrolizumab (KEYTRUDA) plus chemotherapy. You won't get to choose which one you receive; it will be decided randomly, like flipping a coin. You will have regular visits to the hospital or clinic for your treatments and to have check-ups. These check-ups will involve things like blood tests, scans (X-rays, CT scans, or MRI scans), and physical examinations to see how you're responding to the treatment and to monitor for any side effects. The exact number of visits and the total length of your participation will depend on how you respond to the treatment, but you would receive more detailed information about the schedule from the study team.

Potential risks and benefits

Taking part in a clinical trial means you might get a new treatment that could be more effective than existing ones, but there's no guarantee. You'll also be closely monitored by a medical team. However, there are also risks, as new treatments can have side effects, and some might be serious. The combination of drugs might also lead to unpredictable reactions. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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Netherlands
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Belgium
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Spain
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Greece
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Portugal
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Romania
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Poland

Common questions

What is 'advanced non-small cell lung cancer'?

This is a type of lung cancer that has grown or spread beyond where it started in the lung, often to other parts of the body.

What is chemotherapy?

Chemotherapy is a type of cancer treatment that uses powerful drugs to kill fast-growing cells in your body, usually cancer cells.

What are vudalimab and pembrolizumab?

These are newer types of cancer medicines called immunotherapy. They work by helping your body's immune system fight cancer cells more effectively.

Will I know which treatment I'm getting?

No, in this study, you won't know if you're getting vudalimab or pembrolizumab with chemotherapy; it's decided by chance to ensure the study is fair.

What does 'first-line treatment' mean?

It means this study is for people who are receiving treatment for their advanced non-small cell lung cancer for the very first time. They haven't had other treatments for it yet.