Not recruiting

Study of Abemaciclib and Erlotinib for Patients with Stage IV Non-Small Cell Lung Cancer with KRAS Mutation After Platinum-Based Chemotherapy

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC), specifically in patients who have a detectable KRAS mutation and have previously been treated with chemotherapy. The study is comparing two treatments: one group of participants will receive a medication called Abemaciclib (also known by its code name LY2835219) along with the best supportive care, while the other group will receive a medication called Erlotinib along with the best supportive care. Both medications are taken orally.

The purpose of the study is to compare the effectiveness of these two treatments in terms of overall survival, which means the length of time patients live after starting the treatment. Participants will be randomly assigned to one of the two treatment groups. The study will continue for a period of up to eight months, during which participants will receive their assigned treatment and be monitored regularly by the study team.

Throughout the study, participants will receive supportive care, which includes treatments and therapies aimed at improving quality of life and managing symptoms. The study aims to provide valuable information on which treatment may offer better outcomes for patients with this specific type of lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, a confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) with a KRAS mutation is required. Previous chemotherapy treatment is also necessary.
Step 2
Randomization
Participants are randomly assigned to one of two groups. One group receives abemaciclib with best supportive care, and the other group receives erlotinib with best supportive care.
Step 3
Medication administration
Abemaciclib and erlotinib are both administered orally. The specific dosage and frequency are determined by the study protocol and will be communicated to participants by the study team.
Step 4
Monitoring and follow-up
Participants are monitored regularly to assess their overall survival and response to the treatment. This includes routine check-ups and assessments as outlined by the study protocol.
Step 5
Study duration
The study is expected to continue until December 31, 2024. Participants will be followed from the date of randomization until the date of death from any cause, or until the study ends, whichever comes first.

Who can join the trial?

5 criteria

The participant must have a confirmed diagnosis of **stage IV non-small cell lung cancer (NSCLC)**. This means the cancer has spread to other parts of the body.
The participant must have a tumor with a **KRAS mutation**. This is a specific change in the cancer cells that will be checked during the screening process.
The participant must have received **prior chemotherapy**. This means they have already been treated with cancer-fighting drugs.
The study is open to both **male and female** participants.
The study includes participants from a **vulnerable population**. This means people who might need extra protection or care.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer than Non-Small Cell Lung Cancer cannot participate. This type of cancer affects the lungs.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible to participate.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study, cannot participate.

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Verified sites

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Assistance Publique Hopitaux De Marseille
Verified
Marseille, France

Trial locations

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Investigated drugs

Abemaciclib
is a medication used in this study to help treat patients with advanced lung cancer. It works by blocking certain proteins that are involved in the growth and spread of cancer cells. This medication is given alongside the best supportive care to help improve the patient's overall survival.
Erlotinib
is another medication used in this study for treating advanced lung cancer. It targets specific proteins on cancer cells, which can help slow down or stop their growth. Like abemaciclib, erlotinib is also given with the best supportive care to enhance the patient's chances of survival.

What is already known about the treatment

Abemaciclib
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC) with a KRAS mutation. It is classified as a CDK4/6 inhibitor, which works by blocking proteins that promote cell division, thereby slowing the growth of cancer cells. Abemaciclib is being compared to erlotinib in terms of overall survival in patients who have progressed after platinum-based chemotherapy.
Erlotinib
This medication is also taken orally and is used in the treatment of non-small cell lung cancer. It is an established medication in medical literature and is classified as an EGFR inhibitor. Erlotinib works by blocking the epidermal growth factor receptor, which is involved in the growth and spread of cancer cells. It is being evaluated in clinical trials alongside abemaciclib to assess its effectiveness in improving overall survival in patients with advanced NSCLC.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and difficulty breathing. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. Early detection is crucial for managing the disease effectively.