Not recruiting

Study of Ramucirumab and Erlotinib for Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer

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 Metastatic Non-Small Cell Lung Cancer (NSCLC). This is a condition where cancer cells have spread from the lungs to other parts of the body. The study is investigating the effectiveness and safety of a treatment combination involving two medications: Ramucirumab and Erlotinib. Ramucirumab is given as a solution through an infusion, which means it is administered directly into the bloodstream, while Erlotinib is taken orally in pill form.

The purpose of the study is to evaluate how well the combination of Ramucirumab and Erlotinib works compared to a combination of a placebo and Erlotinib in patients who have not received any previous treatment for their cancer. The study is specifically looking at patients whose cancer has a specific change in their genes called an EGFR mutation. This mutation affects the epidermal growth factor receptor, which is involved in the growth and spread of cancer cells. The study will also explore the use of Ramucirumab with another medication, Gefitinib, and later with Osimertinib for patients whose cancer progresses despite initial treatment.

Participants in the study will receive treatment over a period of time, with regular monitoring to assess the safety and effectiveness of the medications. The study is divided into different parts, with each part focusing on different combinations of treatments and patient groups. The goal is to find the best treatment approach for patients with this type of lung cancer, particularly those with the EGFR mutation. The study will help determine if these medication combinations can improve outcomes for patients with metastatic NSCLC.

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 involves the use of two medications: ramucirumab and erlotinib. Ramucirumab is administered through an infusion, while erlotinib is taken orally.
Participants will receive erlotinib as a first-line treatment. The dosage and frequency of erlotinib will be determined by the study protocol and the healthcare team overseeing the trial.
Step 2
Combination treatment phase
In this phase, participants will receive a combination of ramucirumab and erlotinib. The purpose is to evaluate the effectiveness and safety of this combination compared to a placebo with erlotinib.
The treatment will continue as long as it is deemed beneficial and safe for the participant, or until the disease progresses.
Step 3
Monitoring and assessment
Participants will undergo regular monitoring to assess the response to the treatment. This includes medical examinations, imaging tests, and laboratory tests.
The primary goal is to measure progression-free survival, which is the time from the start of treatment until the disease progresses or the participant passes away from any cause.
Step 4
Safety evaluation
Throughout the study, any side effects or adverse events will be closely monitored. This is to ensure the safety and tolerability of the treatment combination.
Participants will be required to report any new symptoms or changes in their health to the study team promptly.
Step 5
End of study
The study is expected to conclude by December 16, 2024. Participants will be informed about the results and any further steps if necessary.
Upon completion, participants may have follow-up visits to monitor their health and discuss any ongoing treatment needs.

Who can join the trial?

6 criteria

The patient must have a confirmed diagnosis of **Stage IV Non-Small Cell Lung Cancer (NSCLC)**. This means the cancer has spread beyond the lungs.
The patient should be eligible for first-line treatment with a medication called **erlotinib**. This is based on evidence that the tumor has a specific change in the **EGFR gene** (either exon 19 deletion or exon 21 L858R mutation).
The patient must provide a sample of their cancer tissue. This is usually from a previous biopsy or surgery. For some parts of the study, this may not be required.
The patient must have at least one **measurable lesion**. This means there is a tumor that can be measured to see if it changes in size during the study.
The patient should have a life expectancy of at least 3 months.
Both male and female patients can participate.

Who cannot join the trial?

10 criteria

Patients who have received any previous treatment for their lung cancer.
Patients with other types of cancer that are currently being treated.
Patients with serious heart problems, such as heart failure or a recent heart attack.
Patients with uncontrolled high blood pressure.
Patients with active infections that require treatment.
Patients who are pregnant or breastfeeding.
Patients with known allergies to the study medications.
Patients with a history of bleeding disorders.
Patients with severe liver or kidney disease.
Patients who are unable to follow the study procedures or attend study visits.

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Verified sites

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

Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
Hospital Universitario Quironsalud Madrid
Verified
Pozuelo De Alarcon, Spain
Institut Catala D'oncologia
Verified
L'hospitalet De Llobregat, Spain

Trial locations

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Investigated drugs

Erlotinib
is a medication used to treat non-small cell lung cancer (NSCLC) that has specific mutations in the epidermal growth factor receptor (EGFR). It works by blocking the activity of EGFR, which can slow down or stop the growth of cancer cells.
Ramucirumab
is a medication that targets and blocks a protein called VEGFR-2, which is involved in the formation of blood vessels that supply nutrients to tumors. By blocking this protein, ramucirumab can help to slow the growth of cancer by cutting off its blood supply.
Gefitinib
is another medication used to treat non-small cell lung cancer with EGFR mutations. Similar to erlotinib, it works by inhibiting the activity of EGFR, thereby slowing the growth and spread of cancer cells.
Osimertinib
is a medication used for treating non-small cell lung cancer that has specific mutations, including the T790M mutation. It works by targeting and inhibiting the mutated forms of EGFR, helping to control the growth of cancer cells that have become resistant to other treatments.

What is already known about the treatment

Erlotinib
Erlotinib is administered orally in tablet form and is used primarily for the treatment of metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. It is well-documented in medical literature as a targeted therapy that inhibits the epidermal growth factor receptor (EGFR) tyrosine kinase, which is involved in the growth and spread of cancer cells. Erlotinib belongs to the pharmacological class of tyrosine kinase inhibitors and is often used in combination with other medications to enhance its effectiveness.
Ramucirumab
Ramucirumab is administered intravenously and is used in combination with other drugs for the treatment of metastatic non-small cell lung cancer (NSCLC) with EGFR mutations. It is recognized in medical literature as a monoclonal antibody that targets the vascular endothelial growth factor receptor 2 (VEGFR-2), thereby inhibiting angiogenesis, which is the formation of new blood vessels that tumors need to grow. Ramucirumab is classified as an angiogenesis inhibitor and is used to improve outcomes in cancer therapy.
Gefitinib
Gefitinib is taken orally in tablet form and is used for treating metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. It is well-established in medical literature as a targeted therapy that blocks the activity of the epidermal growth factor receptor (EGFR) tyrosine kinase, which plays a role in cancer cell proliferation. Gefitinib is part of the tyrosine kinase inhibitor class and is often used in combination with other treatments to enhance its therapeutic effects.
Osimertinib
Osimertinib is administered orally in tablet form and is used for treating metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations, particularly in cases where the disease has progressed after other treatments. It is known in medical literature as a third-generation EGFR tyrosine kinase inhibitor that targets both the EGFR mutation and the T790M resistance mutation, which can develop during treatment. Osimertinib is classified as a tyrosine kinase inhibitor and is used to manage advanced stages of lung cancer.

Investigated diseases

Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and has spread to other parts of the body. It is characterized by the uncontrolled growth of abnormal cells in the lung tissue, which can form tumors. As the disease progresses, these cancerous cells can invade nearby tissues and organs, and eventually spread to distant parts of the body through the bloodstream or lymphatic system. The progression of the disease can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. The presence of specific genetic mutations, such as those in the epidermal growth factor receptor (EGFR), can influence the behavior and progression of the cancer.