Active not recruitingPHASE1INTERVENTIONAL

A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

This research study is investigating a new treatment approach for advanced non-small cell lung cancer and a certain type of breast cancer (hormone receptor positive, HER2 negative). It's looking at using two medicines together: abemaciclib and pembrolizumab. The main goal is to understand how safe this combination is and how well it works to treat these cancers. This is an early-stage study, meaning it's one of the first times this combination is being tested in people. If you have one of these conditions and meet certain criteria, you might be able to take part. The study will carefully monitor participants to see how they respond to the treatment and whether there are any side effects.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Eli Lilly and Company

Enrolment target

100

Start

14 Nov 2016

Estimated completion

01 Dec 2026

Non Small Cell Lung Cancer Breast Cancer

What is this study about?

This study is an important step in finding new and better ways to treat advanced non-small cell lung cancer and a specific kind of breast cancer. These conditions can be challenging, and doctors are always looking for more effective treatments. This research focuses on giving two different medicines, abemaciclib and pembrolizumab, at the same time. Abemaciclib is a type of targeted therapy, and pembrolizumab is an immunotherapy, which helps your body's immune system fight cancer.

The idea behind combining these medicines is that they might work better together than either one alone. Scientists believe that by tackling the cancer from different angles, they could improve how well the treatment works and help people live longer or have a better quality of life. This is a "Phase 1" study, which means it's one of the first human trials. It's mainly designed to find the safest dose of the combined medicines and see if there are any serious side effects.

While the primary goal is to check safety, researchers will also be looking closely at how effective the treatment is against the cancer. They'll measure things like whether the tumours shrink or stop growing. The information gathered from this study will help doctors decide if this combination treatment should be tested in larger studies in the future, potentially bringing new hope to people living with these cancers.

Key takeaways

This study evaluates a new combination treatment for advanced lung and breast cancers.
It's a Phase 1 study, focusing on safety and finding the right dose.
Participation involves regular clinic visits, blood tests, and scans.
You'll need to provide tumour tissue samples before and after treatment starts.
Potential benefits include access to new treatment; risks include possible side effects.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and have advanced non-small cell lung cancer or a specific type of breast cancer (which means it's hormone receptor positive and HER2 negative). Your cancer needs to be at a stage where it has spread to other parts of your body or is advanced locally.

There are some specific requirements based on your cancer type and past treatments. For example, some people with lung cancer must not have had chemotherapy for their advanced cancer before, while others must have had at least one platinum-based chemotherapy. For breast cancer, some participants need to have had one or two previous chemotherapy treatments for their advanced cancer, while others can't have had any hormone therapy or chemotherapy for their advanced disease. Everyone needs to be able to provide tumour tissue samples both before starting treatment and after.

There are also some reasons why you might not be able to join. For instance, if you have a history of certain heart problems like fainting often, irregular heartbeats, or sudden cardiac arrest, this study might not be suitable for you. You also need to be generally well, meaning you can do most of your daily tasks without much trouble, and doctors will need to be able to measure your tumour to see if the treatment is working. For some women with breast cancer, you would also need to be past menopause.

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 advanced non-small cell lung cancer or specific breast cancer?
Are you generally well enough to do your daily activities?
Are you able to provide tumour samples?
Have you discussed your past treatments with the study team?
Do you have a history of certain serious heart problems?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the experimental medicines, abemaciclib and pembrolizumab. You'll have regular visits to the clinic for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. Your tumour will be measured regularly to track its size. You will also be asked to provide tumour samples before the treatment starts and again after you begin treatment. The number of visits and the total length of your participation will depend on how you respond to the treatment and your health. The study team will explain the full schedule to you in detail.

Potential risks and benefits

Like all medical treatments, there are potential benefits and risks to consider. A potential benefit of joining this study is getting access to a new treatment combination that might work better than existing options. It could also help doctors learn more about cancer, which could benefit others in the future. However, there are also potential risks, including side effects from the medicines, which could range from mild to serious. The study team will closely monitor you for any side effects and will explain all known risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (24)

Highlands Oncology Group - Duplicate 2
Verified postcode
Springdale, United States
Univ of California San Francisco
Verified postcode
San Francisco, United States
University of Colorado School of Medicine
Verified postcode
Aurora, United States
Dana Farber Cancer Institute
Verified postcode
Boston, United States
Karmanos Cancer Institute
Verified postcode
Detroit, United States
Karmanos Cancer Institute
Verified postcode
Farmington Hills, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Verified postcode
Leuven, Belgium
Centre Hospitalier Universitaire Sart Tilman
Verified postcode
Liège, Belgium
Centre Oscar Lambret
Verified postcode
Lille, France
Hôpital Arnaud de Villeneuve - CHU Montpellier
Verified postcode
Montpellier, France
Hopital Larrey
Verified postcode
Toulouse, France

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer, and it's called 'non-small cell' because of how the cancer cells look under a microscope.

What is breast cancer (HR+, HER2-)?

This is a type of breast cancer where the cancer cells grow in response to hormones (HR+), but they don't have too much of a protein called HER2 (HER2-).

What does a 'Phase 1' study mean?

It's an early-stage study designed to find the safest dose of a new treatment and understand its side effects, rather than primarily proving how well it works.

Will I get paid to join the study?

Most clinical trials do not pay participants directly, but they may cover costs related to study visits, like travel expenses.

What happens if the treatment doesn't work for me?

The study doctors will discuss your options with you and help you decide on the next steps for your care.