Active not recruitingPHASE3INTERVENTIONAL

A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

This research study is investigating an experimental medicine called abemaciclib for people in the UK who have a type of advanced lung cancer known as non-small cell lung cancer (NSCLC). Specifically, it's for those whose cancer has a particular genetic change called a KRAS mutation (in codons 12 or 13), and whose cancer has continued to grow after previous treatments, including platinum-based chemotherapy and another therapy like immunotherapy. The main goal is to find out how safe abemaciclib is and how well it works compared to another approved treatment, erlotinib. This is a Phase 3 study, meaning it's a key step in seeing if this new treatment could become widely available for eligible patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

453

Start

03 Oct 2014

Estimated completion

01 Dec 2026

Non Small Cell Lung Cancer

Results

Results from this study

Posted December 2018

Results have been published for this study.

Primary outcome

Overall Survival (OS)

OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

Full results on the registry

What is this study about?

This research is looking into a new treatment for non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. Sometimes, cancer cells have specific changes in their genes that can make them grow. This study focuses on people whose NSCLC has a particular gene change called a KRAS mutation. This mutation is found in some lung cancers and can make them harder to treat.

The study is testing a drug called abemaciclib. This drug works by targeting specific processes in cancer cells that help them grow and divide. The main aim is to see if abemaciclib is a safe and effective treatment for people whose KRAS-mutated NSCLC has progressed even after they've had other treatments like chemotherapy and possibly immunotherapy. Researchers want to compare abemaciclib to another standard treatment called erlotinib to determine which works better.

Finding new ways to treat lung cancer, especially when it has specific gene changes like the KRAS mutation, is very important. This study is a 'Phase 3' trial, which is usually the last step before a new medicine might be considered for approval. By taking part, people could help researchers learn more about abemaciclib and potentially help future patients with similar conditions.

Key takeaways

Tests a new drug (abemaciclib) for advanced lung cancer.
Specifically for non-small cell lung cancer with a KRAS gene mutation.
For those whose cancer has progressed after previous treatments.
Compares abemaciclib to another approved drug (erlotinib).
Aims to check safety and how well the treatment works.
Participation could help advance lung cancer treatment.

Who may be eligible?

To be able to take part in this study, you would need to meet several specific criteria. Firstly, you must have been diagnosed with advanced non-small cell lung cancer (Stage 4). Your doctors would also need to confirm that your cancer has a specific gene change called a KRAS mutation.

Your cancer must have continued to grow despite having tried at least two different types of treatment in the past. This includes a platinum-based chemotherapy, and then another treatment, which could be immunotherapy or another anti-cancer medicine. Alternatively, if your doctor believes you are not well enough for further standard chemotherapy, you might still be considered.

There are also some things that would mean you couldn't join the study. For example, if you've had certain heart problems or if you've recently used other experimental drugs. Your overall health and how well you can carry out daily activities (known as performance status) would also be checked, and you would need to be in a generally good condition.

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.

Have I been diagnosed with advanced (Stage 4) non-small cell lung cancer?
Has my doctor confirmed that my cancer has a KRAS gene mutation?
Has my cancer continued to grow after I've had at least two previous treatments (like chemotherapy and another therapy)?
Am I at least 18 years old?
Am I generally in good health, able to carry out daily activities?
Have I stopped any previous cancer treatments at least 2-3 weeks ago?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study drug, abemaciclib, or another approved drug called erlotinib. This would be determined randomly, like flipping a coin for fairness. You would have regular visits to the hospital or clinic for check-ups, blood tests, and scans to see how your body is responding to the treatment and to monitor for any side effects. The study will continue as long as the treatment is helping you and you are not experiencing severe side effects. The total length of your participation would depend on how your cancer responds to the treatment and your general health, but you would be fully informed about the schedule and expectations before you start.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from receiving a new treatment that could be more effective for your cancer, or you might help advance medical knowledge. However, there's no guarantee that the treatment will work for you, and you might experience side effects, some of which could be serious. All potential side effects would be fully explained to you before you agree to join. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (231)

Highlands Oncology Group
Verified postcode
Fayetteville, United States
St. Bernards Medical Center
Verified postcode
Jonesboro, United States
City of Hope National Medical Center
Verified postcode
Duarte, United States
University of California - San Diego
Verified postcode
La Jolla, United States
Loma Linda University School of Medicine
Verified postcode
Loma Linda, United States
CBCC Global Research, Inc.
Verified postcode
Los Angeles, United States
Central Coast Medical Oncology Corporation
Verified postcode
Los Angeles, United States
Fort Wayne Oncology & Hematology
Verified postcode
Los Angeles, United States
SMO TRIO -Translational Research
Verified postcode
Los Angeles, United States
St. Joseph Heritage Medical Group
Verified postcode
Los Angeles, United States
UCLA Department of Medicine-Hematology/Oncology
Verified postcode
Los Angeles, United States
Cancer Care Associates Medical Group
Verified postcode
Los Angeles, United States

Common questions

What is non-small cell lung cancer (NSCLC) Stage 4?

Stage 4 NSCLC means the cancer has spread from the lung to other parts of the body.

What is a KRAS mutation?

It's a specific change in a gene within the cancer cells that can make them grow. This study is for people with this particular change.

What does 'platinum-based chemotherapy' and 'immunotherapy' mean?

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

What is abemaciclib?

Abemaciclib is an investigational drug being tested to see if it can help treat certain lung cancers with a specific gene change.

Is this study a new treatment for everyone with lung cancer?

No, this study is only for people with a very specific type of advanced lung cancer that has a KRAS genetic mutation and has progressed after other treatments.