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Study on Pembrolizumab, Etoposide, and Cisplatin or Carboplatin for First-Line Treatment in Patients with Extensive-Stage Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of extensive-stage small cell lung cancer (ES-SCLC), a type of lung cancer that has spread widely throughout the body. The study aims to evaluate the effectiveness and safety of a combination of treatments for patients who are receiving their first line of therapy for this condition. The treatments being tested include a combination of Pembrolizumab, also known as Keytruda, with other investigational agents such as Lenvatinib (code name MK-7902), MK-4830, and Boserolimab (code name MK-5890), along with standard chemotherapy drugs like Etoposide, Cisplatin, or Carboplatin.

The purpose of this study is to determine how well these treatments work together in controlling the cancer and to assess their safety. Participants in the study will receive these medications either through an intravenous infusion, which is a method of delivering medicine directly into the bloodstream, or orally in the form of capsules. The study will monitor the participants over a period to see how their cancer responds to the treatment and to check for any side effects.

Throughout the study, participants will undergo regular assessments to track the progress of their cancer and to ensure their safety. These assessments will help researchers understand the potential benefits and risks of using these combinations of treatments for patients with extensive-stage small cell lung cancer. The study is designed to provide valuable information that could lead to improved treatment options for this challenging condition.

1 initial treatment phase

Begin with the administration of etoposide and cisplatin or carboplatin. These medications are given through an intravenous infusion. The specific dosage and frequency will be determined by the medical team based on individual needs.

In addition to the above, pembrolizumab is administered as a concentrate for solution for infusion. This is also given intravenously.

2 combination therapy phase

Receive lenvatinib in capsule form for oral use. The dosage and frequency will be specified by the healthcare provider.

Continue with MK-4830 and boserolimab, both administered through intravenous infusion. The schedule for these medications will be provided by the medical team.

3 monitoring and assessment phase

Undergo regular assessments to monitor the response to treatment. This includes imaging studies and other tests as required.

The objective response rate and progression-free survival will be evaluated according to specific criteria.

4 follow-up phase

After completing the treatment regimen, participate in follow-up visits to assess long-term outcomes and any potential side effects.

The duration of response and overall survival will be monitored, along with any changes in quality of life.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC), which means the cancer has spread widely in the body and needs first-line treatment.
  • The patient must have adequate organ function, meaning their organs are working well enough, within 10 days before starting the study treatment.
  • The patient must have controlled blood pressure, which means their blood pressure is at or below 150/90 mm Hg, with or without medication, and no changes in blood pressure medication within one week before starting the study.
  • The patient must have ES-SCLC classified as Stage IV, which is a stage where the cancer has spread to other parts of the body.
  • Male patients must agree to use contraception or be abstinent from heterosexual intercourse during the study and for a certain time after the last dose of study treatment, depending on the specific medication.
  • Female patients must not be pregnant or breastfeeding and must agree to use effective contraception or be abstinent during the study and for a certain time after the last dose of study treatment, depending on the specific medication.
  • Women of childbearing potential must have a negative pregnancy test before starting the study treatment.
  • Female patients must not breastfeed during the study and for at least 120 days after the study treatment.
  • The patient must have measurable disease, meaning the cancer can be measured by doctors using specific criteria.
  • The patient must provide a sample of their tumor tissue, either from a previous biopsy or a new one, if available.
  • The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work, assessed within 7 days before starting the study.

Who Cannot Join the Study?

  • Patients who have received prior treatment for their lung cancer.
  • Patients with other types of cancer that are not under control.
  • Patients with serious heart problems.
  • Patients with active infections that require treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients with known allergies to the study medication.
  • Patients who are unable to follow the study procedures.
  • Patients with a history of drug or alcohol abuse.
  • Patients with certain medical conditions that could interfere with the study.
  • Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Koranyi National Institute For Pulmonology Budapest Hungary

Other Sites

Site Name City Country Status
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Krankenhaus Nord Klinik Floridsdorf Vienna Austria
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Ospedale San Raffaele S.r.l. Milan Italy
Semmelweis University Budapest Hungary
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Ijytqkuj Cnjmkt Dqbzgnbwbfbuisfgp L'hospitalet De Llobregat Spain
Aqjgdze Orcuatgybyn Uzzpbryaeaktk Sbolqh Siena Italy
Nvqafmbk Ihozmzwy Olyogbphf Ird Mnasn Sjtssnlymppikssiihwsmqoefxfh Iebveiie Buvyixqo Cracow Poland
Hotpwekt Vppn dbwasbri Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
02.07.2021
Hungary Hungary
Not recruiting
02.07.2021
Italy Italy
Not recruiting
02.07.2021
Poland Poland
Not recruiting
02.07.2021
Spain Spain
Not recruiting
02.07.2021

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this trial to help the immune system detect and fight cancer cells. It works by blocking a specific protein that prevents the immune system from attacking cancer cells, thereby enhancing the body’s natural defense against cancer.

Etoposide is a chemotherapy drug that helps stop the growth of cancer cells by interfering with their DNA. It is used in combination with other medications to treat small cell lung cancer by slowing or stopping the spread of cancer cells.

Cisplatin is another chemotherapy medication used in this trial. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. This helps to reduce the size of tumors and slow the progression of cancer.

Carboplatin is similar to cisplatin and is used as an alternative chemotherapy drug in this study. It also targets the DNA of cancer cells, helping to stop their growth and spread. It is often chosen for patients who may experience fewer side effects compared to cisplatin.

Extensive-Stage Small Cell Lung Cancer – This is a type of lung cancer characterized by the rapid growth of small cells in the lung tissue. It is classified as “extensive-stage” when the cancer has spread beyond the lung to other parts of the body. The disease progresses quickly, often leading to symptoms such as coughing, chest pain, and difficulty breathing. As the cancer advances, it may also cause weight loss, fatigue, and swelling in the face or neck. The progression of the disease can vary, but it typically involves the spread to distant organs, including the liver, brain, and bones.

Trial ID:
2023-506538-56-00
Protocol code:
MK-3475-B99
NCT ID:
NCT04924101
Trial Phase:
Therapeutic exploratory (Phase II)

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