Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

KEYMAKER-U01 Substudy 1: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents with Pembrolizumab in Combination with Chemotherapy in Treatment-Naive Patients with Advanced Non-small Cell Lung Cancer (NSCLC)

This study, called KEYMAKER-U01, is exploring new ways to treat advanced non-small cell lung cancer in people who are just starting treatment. It's a 'Phase 2' study, which means it's still in the earlier stages of research, focusing on whether new drugs, like rolistobart or boserolimab, work well when given alongside pembrolizumab (KEYTRUDA) and standard chemotherapy. Researchers want to see if these new combinations can shrink tumors and what side effects they might cause. The goal is to find more effective treatments that can help patients live longer and better.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

163

Start

03 Jan 2024

non-small cell lung cancer

What is this study about?

This research study is about finding better treatments for a type of lung cancer called non-small cell lung cancer, specifically when it's advanced and hasn't been treated before. It's like a scientific experiment where doctors are trying out different new medications in combination with a drug called pembrolizumab (also known as KEYTRUDA) and standard chemotherapy. Think of it as trying different recipes with some well-known ingredients and some new ones to see which combination tastes best, or in this case, works best against cancer.

The main goal is to see how well these new drug combinations can shrink tumors. They're also carefully watching for any side effects to understand how safe these new treatments are. This is a 'Phase 2' study, meaning it's an important step in developing new medicines. If these combinations show promise here, they might move on to larger studies later.

By participating, patients help doctors learn more about these new treatments, potentially leading to more effective options for people with advanced non-small cell lung cancer in the future. It's all about improving care and outcomes for patients with this condition.

Key takeaways

Tests new drug combinations for advanced lung cancer.
For patients who haven't had previous treatment for their advanced lung cancer.
Aims to see if tumors shrink and to check for side effects.
Includes well-known drugs like KEYTRUDA and chemotherapy.
Participation helps advance future lung cancer treatments.

Who may be eligible?

To join this study, you would need to be at least 18 years old. Both men and women can take part.

The study is specifically for people who have been diagnosed with advanced non-small cell lung cancer and who have not yet received any treatment for their cancer. This means you would be considered 'treatment-naive'.

Other specific medical details will be checked by the study doctors to make sure the treatment is safe and suitable for you. This might include certain blood test results or how well other organs in your body are working.

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?
Have you been diagnosed with advanced non-small cell lung cancer?
Have you NOT had any treatment for your advanced lung cancer yet?
Are you able to attend regular appointments and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive different medications as part of your treatment plan, likely given through an infusion into your vein. You will have regular visits to the hospital or clinic for these treatments and to have check-ups with the doctors and nurses. These visits will include tests like blood samples, scans (like X-rays or CT scans) to see how the cancer is responding, and general health checks.

The doctors will closely monitor you for any side effects. The total length of your participation will vary depending on how you respond to the treatment and your overall health, but you would be under medical care for the duration of the treatment and then usually have follow-up appointments for a period after treatment finishes.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to receive new treatments that are not yet widely available, and these could potentially be more effective than current options for your condition. However, there are also potential risks, as the new drugs might have side effects that are not fully known or could be severe. You will be closely monitored for any unwanted effects. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

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

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Unverified
Italy
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Unverified
Hungary
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Unverified
Poland
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Unverified
Spain

Common questions

What kind of cancer is this study for?

This study is for people with advanced non-small cell lung cancer that hasn't been treated before.

What is a 'Phase 2' study?

Phase 2 means it's an earlier stage of research, testing if a new treatment works well and is safe, after initial safety tests in Phase 1.

What drugs are being tested?

The study is testing new drugs like rolistobart and boserolimab alongside pembrolizumab (KEYTRUDA) and standard chemotherapy.

What will doctors be looking for?

They will primarily check how much the tumors shrink and if the new treatments cause any side effects.

Do I have to pay to be in the study?

No, you don't have to pay for the study drugs or related medical care involved in the trial.