Study of Pembrolizumab, Lenvatinib, and Chemotherapy for First-Line Treatment in Extensive-Stage Small Cell Lung Cancer Patients

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as extensive-stage small cell lung cancer (ES-SCLC). The study will explore the effects of a combination treatment that includes the medications pembrolizumab and lenvatinib, along with chemotherapy drugs carboplatin and etoposide. Pembrolizumab is administered as a solution for infusion, while lenvatinib is taken in capsule form. The purpose of the study is to evaluate the safety and effectiveness of this combination treatment in patients who are receiving their first line of treatment for this type of lung cancer.

The study will be conducted in two parts. In the first part, the focus will be on assessing the safety and tolerability of lenvatinib when used with pembrolizumab and chemotherapy. This means checking how well patients can handle the treatment and identifying any side effects. In the second part, the study will look at how long patients can live without their cancer getting worse, which is known as progression-free survival. This will help determine if the combination treatment is effective in controlling the cancer.

Participants in the study will receive the treatment over a period of time, with regular monitoring by healthcare professionals. The study aims to provide valuable information on the potential benefits and risks of using pembrolizumab and lenvatinib together with chemotherapy for treating extensive-stage small cell lung cancer. This research could contribute to improving treatment options for patients with this type of cancer.

1 initial treatment phase

The initial phase involves the administration of medications to evaluate their safety and how well they are tolerated. This phase is known as the safety run-in.

During this phase, you will receive a combination of medications: lenvatinib at a dose of 8 mg taken orally, pembrolizumab administered through an intravenous infusion, and chemotherapy drugs carboplatin and etoposide.

2 treatment phase

In the treatment phase, the focus is on assessing how long the disease does not progress, known as progression-free survival.

You will receive lenvatinib at a higher dose of 20 mg taken orally, along with pembrolizumab and the chemotherapy drugs carboplatin and etoposide.

3 monitoring and assessment

Throughout the trial, regular monitoring will occur to assess the response to treatment and any side effects.

The effectiveness of the treatment will be evaluated using criteria known as RECIST 1.1, which helps in measuring how the cancer responds to the treatment.

4 completion and follow-up

After completing the treatment phases, follow-up assessments will be conducted to monitor your health and any long-term effects of the treatment.

The trial is expected to continue until March 2028, with regular check-ins to ensure your well-being and gather data on the treatment’s effectiveness.

Who Can Join the Study?

Have a new diagnosis of small cell lung cancer confirmed by a test called histology or cytology, which examines cells from the lungs.
Male participants must agree to avoid donating sperm and either abstain from heterosexual intercourse or use contraception during the study and for a specified time after the last dose of medication.
Female participants must not be pregnant or breastfeeding and must use a highly effective form of birth control or abstain from heterosexual intercourse during the study and for a specified time after the last dose of medication. They must also have a negative pregnancy test before starting the study.
Agree to participate in the study by signing a written consent form.
Have organs that are working well enough to participate in the study.
Have extensive-stage small cell lung cancer, which is a specific stage of the disease.
Have at least one tumor that can be measured according to specific criteria used by doctors.
Provide a sample of tumor tissue for testing, either from a previous biopsy or a new one.
Be at least 18 years old at the time of signing the consent form.
Have a life expectancy of at least 3 months from the start of the study.
Have a performance status of 0 to 1, which means being fully active or having some symptoms but still able to carry out light work, as assessed within 7 days before the first dose of the study medication.

Who Cannot Join the Study?

Patients who have received previous treatment for their lung cancer.
Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have allergies to the study medications.
Patients with a history of other cancers, unless they have been in remission for a certain period.
Patients with active infections that require treatment.
Patients with certain heart conditions that could be worsened by the study medications.
Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Basurto	Bilbao	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Pumq Tlzwt Hjvrnlus Ufiotrslowgs	Sabadell	Spain
Hvcrtvgm Dt Lr Shyng Cobb I Spvr Pqc	Barcelona	Spain
Idxysbln Cfhnqh Djpijituggetfmvky	L'hospitalet De Llobregat	Spain
Hydepqeq Vzab dktlzcdu	Barcelona	Spain
Hdiutlvh Uxwmllosvafhj dr A Crrtms	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	20.03.2024

Trial locations

Investigated drugs:

Pembrolizumab is a medication that helps the immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better detect and attack these cells.

Lenvatinib is a medication that helps stop the growth of cancer cells by blocking certain proteins that cancer cells need to grow. It is used in combination with other treatments to enhance their effectiveness.

Carboplatin is a type of chemotherapy that works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is used to treat various types of cancer, including lung cancer.

Etoposide is another chemotherapy drug that works by interfering with the DNA of cancer cells, stopping them from multiplying. It is often used in combination with other chemotherapy drugs to treat lung cancer.

Investigated diseases:

Small cell lung cancer extensive stage

Extensive-Stage Small Cell Lung Cancer (ES-SCLC) – This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It is called “extensive-stage” when the cancer has spread beyond the lungs to other parts of the body. The disease often progresses rapidly, affecting the respiratory system and potentially other organs. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer advances, it can lead to more severe respiratory issues and systemic symptoms. The progression of ES-SCLC can vary, but it typically involves a rapid spread to distant organs.

Trial ID:

2024-511412-25-00

NCT ID:

NCT05384015

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab, Lenvatinib, and Chemotherapy for First-Line Treatment in Extensive-Stage Small Cell Lung Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?