Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy

This research study is looking at a new treatment called MK-7684A for people with a type of lung cancer known as non-small cell lung cancer. This is for patients whose cancer has worsened after already having standard chemotherapy and immunotherapy. The study will compare MK-7684A, either by itself or combined with another common cancer drug called docetaxel, against docetaxel alone. Doctors want to find out if these new approaches can help keep the cancer from growing for a longer time, and if they are safe. This is a Phase 2 study, meaning it's an early stage of testing to see if the new medicine is promising before it's tested on a much larger group of people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

150

Start

13 Feb 2023

Non Small Cell Lung cancer

What is this study about?

This study is about finding better ways to treat a type of lung cancer called non-small cell lung cancer. This particular study is for people whose cancer has already been treated with standard chemotherapy and immunotherapy, but the cancer has unfortunately started to grow again.

Researchers are testing a new medicine, which we'll call MK-7684A for now. They want to see how well it works, both on its own and when given together with a common cancer drug called docetaxel. They'll compare these new treatments to just using docetaxel by itself. The main goal is to find out if these new approaches can stop the cancer from growing for a longer time, which doctors call "progression-free survival." This is a common way to measure whether a cancer treatment is working.

It's important to understand that this is a Phase 2 study. This means it's an earlier stage of research where doctors are trying to get a better idea of how effective and safe a new treatment might be. If the results are promising, the treatment might then move on to larger studies. This research aims to offer new possibilities for patients when their current treatments are no longer enough.

Key takeaways

This study is for advanced non-small cell lung cancer that has progressed after previous treatments.
It tests a new medicine, MK-7684A, alone or with docetaxel, against docetaxel alone.
The main goal is to see if new treatments can stop cancer growth for longer.
It's a Phase 2 study, an early stage in testing promising new treatments.
Regular hospital visits, tests, and scans will be part of participation.

Who may be eligible?

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

You would also need to have non-small cell lung cancer that has spread, and your cancer must have gotten worse after you've already had two specific types of treatment: one called platinum-based chemotherapy and another called immunotherapy. Doctors would carefully check your medical records and do some tests to make sure you meet all the necessary health requirements for the study.

The research team will review all your medical information to see if this study is suitable for you. It's really important that you discuss your full medical history with them.

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 at least 18 years old?
Have you been diagnosed with non-small cell lung cancer that has spread?
Has your cancer started to grow again after receiving both platinum-based chemotherapy and immunotherapy?
Are you able to attend regular hospital appointments and tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to one of three treatment groups: you might receive the new medicine MK-7684A on its own, MK-7684A combined with docetaxel, or docetaxel alone. You won't get to choose which group you're in, and in some parts of the study, neither you nor your doctors will know which specific treatment you are getting. Regular visits to the hospital will be needed for your treatments, health checks, blood tests, and scans (like X-rays or CT scans) to see how the treatment is working. These scans will help doctors measure if the cancer is growing or shrinking. You would continue treatment as long as it's helping you and you're not experiencing severe side effects. The total duration of your participation in the study, including follow-up after treatment, will depend on how you respond to the treatment and the study plan, but there will be ongoing checks for your health over time.

Potential risks and benefits

Participating in a clinical trial offers the chance to access a new treatment that isn't yet widely available, which might help control your cancer. However, there's no guarantee that the new treatment will work for everyone, and it might not be better than standard care. All medications have potential side effects, and the new medicine (MK-7684A) or the combination might cause unexpected reactions, some of which could be serious. The research team will monitor you very closely for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (9)

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

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Unverified
Spain
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Unverified
Denmark
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Unverified
Italy
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Unverified
Finland
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Unverified
Germany
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Unverified
Belgium
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Unverified
France
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Unverified
Austria
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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 advanced cases that have worsened after initial treatments.

What does 'Metastatic' mean?

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

What is 'Platinum Doublet Chemotherapy' and 'Immunotherapy'?

These are common types of cancer treatments. Chemotherapy uses strong drugs to kill cancer cells, and immunotherapy helps your body's immune system fight the cancer.

Will I get a placebo (dummy treatment)?

One group in the study will receive docetaxel, a standard cancer drug. If you're in the group getting MK-7684A plus docetaxel, only the MK-7684A part is compared against a 'placebo' (normal saline, like salty water) to keep the study fair, but you would still receive docetaxel. So everyone receives some form of active treatment relevant to their cancer.

What does a 'Phase 2' study mean?

Phase 2 means it's an early step where researchers check if the new medicine works well enough and is safe enough to be tested on more people in the future.