Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Study of Pembrolizumab in Combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

This important study is testing new treatment options for a type of lung cancer called metastatic squamous non-small cell lung cancer, which has spread to other parts of the body. Researchers want to find out if combining standard chemotherapy (carboplatin and a taxane, like paclitaxel) with pembrolizumab (also known as Keytruda) is a more effective first treatment. In some cases, after this initial treatment, participants might also receive pembrolizumab with or without another drug called olaparib. The goal is to see if these combinations can help patients live longer and keep the cancer from growing for a longer period, while also considering their quality of life. This is a large study (Phase 3) to confirm if these treatments are better.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

151

Start

22 Mar 2024

Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

What is this study about?

This research is focused on a specific type of lung cancer called metastatic squamous non-small cell lung cancer. "Metastatic" means the cancer has spread from where it started to other parts of the body, making it more challenging to treat. The study aims to find better ways to help people living with this condition.

Currently, chemotherapy is a standard treatment for lung cancer. This study is exploring if adding a newer drug called pembrolizumab (also known as Keytruda) to the usual chemotherapy (carboplatin and a taxane like paclitaxel) can improve how well patients do. Pembrolizumab works by helping your body's immune system fight the cancer. After the initial treatment, some people will continue with pembrolizumab, either on its own or with another drug called olaparib. Olaparib is a targeted therapy which can be effective in certain cancers.

The main things the researchers want to find out are whether these new combinations can stop the cancer from growing for a longer time, and if they can help people live longer. They also want to understand how these treatments affect a person's daily life and overall well-being. By carefully comparing different treatment groups, the study hopes to identify better, more effective, and manageable ways to treat this form of lung cancer.

Key takeaways

This study is testing new treatments for a type of spread lung cancer.
It combines standard chemotherapy with newer drugs like pembrolizumab.
The aim is to improve how long people live and keep cancer from growing.
Participants will receive study drugs and have regular health checks.
Your quality of life will also be tracked throughout the study.

Who may be eligible?

To join this study, participants generally need to be at least 18 years old. Both men and women are welcome to take part.

However, there will be very specific medical criteria that you would need to meet. For example, you must have been diagnosed with metastatic squamous non-small cell lung cancer and not have received treatment for this specific stage of cancer yet. It's important that your general health is good enough to safely undergo the treatments in the study.

Your doctor or the study team will carefully review your medical history and current health to determine if this study is a good fit for you. They will make sure it's safe for you to participate and that your specific type of cancer matches the study requirements.

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 metastatic squamous non-small cell lung cancer?
Have you not yet received any treatment for your metastatic lung cancer?
Are you in generally good health, able to cope with chemotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive several different medications. Initially, you would get a combination of pembrolizumab, carboplatin, and either paclitaxel or nab-paclitaxel, which are given as infusions into your vein. After this initial stage, you might receive pembrolizumab on its own, or pembrolizumab combined with olaparib (which would be taken as tablets), or a placebo (a dummy pill) with pembrolizumab. The specific treatment you receive would be decided by chance, like flipping a coin.

Throughout the study, you would have regular visits to the clinic for your treatments, check-ups, and to monitor your health. These visits will involve blood tests, physical exams, and scans to see how the treatment is working and to keep an eye on any side effects. You will also be asked to fill out questionnaires about how you are feeling, which helps the researchers understand the impact on your quality of life. The total duration of your participation in the study, including follow-up, would be communicated by the study team, but generally, these types of trials can last for several months or even a few years.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new treatments before they are widely available. You would also receive very close medical attention during the study. However, there are potential risks, as new treatments can have side effects that aren't fully known yet. These could be mild, like feeling tired, or more serious. The treatments might not work for everyone, or they might not be better than existing options. 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
Austria
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Unverified
Spain
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Unverified
France
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Unverified
Poland
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Unverified
Romania

Common questions

What kind of cancer is this study for?

This study is for a type of lung cancer that has spread, called metastatic squamous non-small cell lung cancer.

What are the main drugs being tested?

The main drugs being tested are pembrolizumab (Keytruda), carboplatin, a taxane (like paclitaxel), and sometimes olaparib.

What are the researchers hoping to achieve?

They hope to find out if these new drug combinations can stop the cancer from growing for longer and help people live longer, while also checking how it affects their quality of life.

Will I definitely receive the new drugs?

You will receive parts of the new drug combinations, but which specific combination you get will be decided by chance, similar to a lottery, to ensure fair testing.

What does 'Phase 3' mean for a study?

Phase 3 means this is a large, advanced stage of research, usually involving many people, to confirm if a new treatment is truly effective and safe compared to current options.