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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
HELIOS Klinikum Emil von Behring GmbH Berlin Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
20.08.2023
Spain Spain
Not recruiting
20.08.2023

Trial locations

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.

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.

Trial ID:
2024-514268-18-00
Protocol code:
I4C-MC-JTBB
NCT ID:
NCT01897480
Trial Phase:
Therapeutic exploratory (Phase II)

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