Not recruiting

Study of Erlotinib and LY2875358 for Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Mutations After Initial Erlotinib Treatment

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 certain changes in a gene called EGFR. The study involves two treatments: a drug called erlotinib and an experimental drug known by its code name LY2875358, which is also called emibetuzumab. Erlotinib is a medication taken by mouth, while LY2875358 is given through an infusion, which means it is delivered directly into the bloodstream.

The purpose of the study is to compare the effectiveness of using LY2875358 together with erlotinib against using erlotinib alone as the first treatment for patients with advanced NSCLC who have shown disease control after an initial 8-week treatment with erlotinib. Initially, all participants will receive erlotinib for 8 weeks. If they show clinical benefit, they will then be randomly assigned to continue with either the combination of LY2875358 and erlotinib or erlotinib alone.

The study will last for a maximum of 240 days, during which the participants' health and response to the treatment will be closely monitored. The main goal is to see how long patients can live without their cancer getting worse, which is known as progression-free survival. This study aims to provide valuable information on whether adding LY2875358 to erlotinib can offer better outcomes for patients with this 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
Initial treatment phase
The study begins with an 8-week treatment period using the medication erlotinib. This medication is taken orally.
During this phase, the goal is to assess the response to the treatment. The patient will continue with this medication if there is a clinical benefit.
Step 2
Randomization and treatment allocation
After the initial 8-week period, if the disease is controlled, the patient will be randomly assigned to one of two groups.
One group will continue to receive erlotinib alone, while the other group will receive a combination of erlotinib and an experimental drug called LY2875358.
Step 3
Combination treatment phase
For patients in the combination group, LY2875358 is administered through an infusion. The frequency and duration of this treatment will be determined by the study protocol.
The purpose of this phase is to compare the effectiveness of the combination treatment against the use of erlotinib alone.
Step 4
Monitoring and assessment
Throughout the study, regular assessments will be conducted to monitor the patient's health and the progression of the disease.
The primary measure of success in this study is progression-free survival, which refers to the time during which the disease does not worsen.
Step 5
End of study
The study is expected to conclude by December 31, 2024.
At the end of the study, the collected data will be analyzed to determine the effectiveness of the treatments.

Who can join the trial?

10 criteria

Have a confirmed diagnosis of **metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)**, which means the cancer has spread to other parts of the body.
Agree to use adequate **contraceptive methods** if you are of reproductive potential, during the study and for at least 12 weeks after the last dose of study therapy.
Have at least one **measurable lesion**, which is a tumor that can be measured using standard medical techniques. If you had radiation therapy before, the measurable lesion must be outside the area that was treated, unless the disease has progressed in that area.
Have **molecular evidence** of a specific type of genetic change in the cancer called **EGFR mutation (EGFRmt)**, which is known to respond to certain drugs. This should be confirmed by testing a sample of the tumor.
Provide enough **tumor material** from a biopsy or surgery for further analysis.
Have a **performance status of 2** on the Eastern Cooperative Oncology Group (ECOG) scale, which is a way to measure how well you can perform daily activities.
Have not received previous **systemic chemotherapy** or other specific treatments for Stage IV NSCLC. If you had chemotherapy for early-stage NSCLC and finished it at least 6 months before joining the study, you may be eligible.
Have **adequate organ function**, meaning your organs are working well enough to participate in the study.
If you need to take **oral anticoagulants** (medications that prevent blood clots), you can participate as long as your blood levels are closely monitored. Your doctor might consider switching you to a different type of blood thinner if needed.
Be at least **18 years old** at the time of screening.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer other than Non-Small Cell Lung Cancer.
Patients who have not shown disease control after an 8-week treatment with erlotinib alone.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medications as required.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent major surgery or are recovering from one.
Patients who have a known allergy to the study medications.
Patients who have a history of drug or alcohol abuse.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
HELIOS Klinikum Emil von Behring GmbH
Berlin, Germany
Verified
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcon, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

LY2875358
is an investigational medication being studied for its potential to enhance the effects of other cancer treatments. In this trial, it is being tested in combination with another medication to see if it can improve outcomes for patients with a specific type of lung cancer.
Erlotinib
is a medication used to treat certain types of lung cancer. It works by blocking the action of a protein that signals cancer cells to grow. In this trial, erlotinib is used both alone and in combination with another investigational medication to determine the best treatment approach for patients with specific genetic mutations in their cancer.

What is already known about the treatment

LY2875358
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication is for patients with NSCLC who have shown disease control after initial treatment with erlotinib. LY2875358 works by targeting specific pathways involved in cancer cell growth and survival, potentially enhancing the effects of other cancer treatments. It is classified as a targeted therapy, focusing on molecular mechanisms specific to cancer cells.
Erlotinib
This medication is taken orally and is an established treatment for certain types of cancer, including non-small cell lung cancer (NSCLC) with specific genetic mutations. It is widely recognized in medical literature and used in clinical practice. Erlotinib is primarily indicated for patients with NSCLC who have specific mutations in the epidermal growth factor receptor (EGFR). It works by inhibiting the activity of EGFR, a protein that promotes the growth of cancer cells. Erlotinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, 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 shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. Early stages may not show noticeable symptoms, making it challenging to detect without medical screening.