Study of MK-7684A, Etoposide, and Platinum Drugs for Patients with Extensive-Stage Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for extensive-stage small-cell lung cancer (ES-SCLC), a type of lung cancer that has spread widely throughout the body. The study is comparing two different treatment combinations to see which one is more effective in helping patients live longer. One treatment involves a combination of a medication called MK-7684A with chemotherapy drugs etoposide and platinum, followed by continued treatment with MK-7684A. The other treatment involves a medication called atezolizumab combined with the same chemotherapy drugs, followed by continued treatment with atezolizumab.

The purpose of the study is to compare the overall survival of patients receiving these treatments. Participants will receive their assigned treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over several months, with regular visits to monitor the participants’ health and response to the treatment. The study will also look at other factors, such as how long the cancer stays under control and the quality of life of the participants during the treatment.

Throughout the study, some participants will receive a saline placebo as part of the treatment process. This is a standard practice in clinical trials to help researchers understand the effects of the actual medications being tested. The trial aims to provide valuable information that could lead to better treatment options for people with extensive-stage small-cell lung cancer in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

A diagnosis of extensive-stage small-cell lung cancer is required, and the condition must be at a specific stage as defined by medical guidelines.

2 treatment group assignment

Participants are randomly assigned to one of two treatment groups. This process is double-blind, meaning neither the participant nor the researchers know which group the participant is in.

One group receives MK-7684A in combination with etoposide and platinum followed by MK-7684A. The other group receives atezolizumab in combination with etoposide and platinum followed by atezolizumab.

3 treatment administration

The medications are administered through an intravenous infusion, which means they are given directly into a vein.

The specific dosage, frequency, and duration of administration are determined by the study protocol and will be explained by the healthcare team.

4 regular monitoring

Participants undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.

This includes physical examinations, imaging tests, and laboratory tests as needed.

5 quality of life assessments

Participants complete questionnaires to evaluate their quality of life during the study. These assessments help understand the impact of the treatment on daily living.

The questionnaires cover various aspects such as physical functioning, pain, and overall health status.

6 end of treatment

At the end of the treatment period, a final assessment is conducted to evaluate the overall response to the therapy.

Participants may be asked to continue follow-up visits to monitor long-term effects and overall survival.

Who Can Join the Study?

The patient has a confirmed diagnosis of extensive-stage small-cell lung cancer (ES-SCLC), which means the cancer has spread widely in the body.
The patient has ES-SCLC that is classified as Stage IV or has large tumors in the lungs that cannot be treated with radiation.
Males must agree to use contraception, not donate sperm, and avoid sexual intercourse with women.
Females must not be pregnant or breastfeeding. If they can have children, they must use a highly effective birth control method or avoid sexual intercourse with men.
The patient has a disease that can be measured according to specific medical guidelines called RECIST 1.1.
The patient is expected to live for more than 3 months.

Who Cannot Join the Study?

Patients with any other type of cancer besides extensive-stage small-cell lung cancer cannot participate.
Patients who have had a different cancer treatment recently may not be eligible.
Patients with serious heart problems or uncontrolled high blood pressure cannot participate.
Patients with active infections, including HIV or hepatitis, are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to similar drugs cannot participate.
Patients with certain autoimmune diseases, where the immune system attacks the body, may not be eligible.
Patients who have had a major surgery recently may not be eligible.
Patients who are currently participating in another clinical trial cannot participate.
Patients with a history of drug or alcohol abuse may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Vall d’Hebron	Barcelona	Spain
Beaumont Hospital	Dublin	Ireland
Assistance Publique Hopitaux De Marseille	Marseille	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)	Rotterdam	The Netherlands
Turku University Hospital	Turku	Finland
Kepler Universitaetsklinikum GmbH	Linz	Austria
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Athens Medical Center S.A.	Thessaloniki	Greece
Medical University Of Graz	Graz	Austria
University Hospital Maastricht	Maastricht	The Netherlands
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
I.F.O. Istituti Fisioterapici Ospitalieri	Rome	Italy
Ordensklinikum Linz GmbH	Linz	Austria
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Oulu University Hospital	Oulu	Finland
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Bacs-Kiskun Varmegyei Oktatokorhaz	Kecskemet	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Med Polonia Sp. z o.o.	Poznan	Poland
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras	Vilnius	Lithuania
Centre Hospitalier Et Universitaire De Limoges	Limoges	France
Champalimaud Clinical Centre	Lisbon	Portugal
Tuedogyogyintezet Toeroekbalint	Torokbalint	Hungary
Centro Hospitalar Universitario Do Porto E.P.E.	Porto	Portugal
Isala Klinieken Stichting	Zwolle	The Netherlands
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Henry Dunant Hospital Center	Athens	Greece
Thoracic General Hospital Of Athens I Sotiria	Athens	Greece
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu	Przemysl	Poland

Other Sites

Site Name	City	Country
Medeuropa S.R.L.	Bucharest	Romania
Wiener Gesundheitsverbund	Vienna	Austria
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.	Siedlce	Poland
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Kkkychbrcxl Nfrr Ksvhal Fqhabkvmgjb	Vienna	Austria
Pfzedqvcoak Lilzxozb &mzlbxpyueejqauftvlh Rocos Kjzrgmyfced	Konin	Poland
Mdsdxcabxhks Htmcfbdj	Athens	Greece
Mektvkd Cozbfav Lgjzfxeguq Bqeq	Leeuwarden	The Netherlands
Snybcmq Svppsiogxfftion W Pobbvdhbt Syc z owal	Prabuty	Poland
Sjn Wneokwdgqvtkh Gqpg Gahh	Gera	Germany
Jpqcdz Bqehb Zhhjmrefhb Sbzxxregf	S-Hertogenbosch	The Netherlands
Hpgpfghi Csu Dgcqvnxzujx Sqzx	Lisbon	Portugal
Vsrbr Cfpftys Homglhxq	Vaasa	Finland
Cyapofq Pelbpnlodsbs I Txkuydpbxcnrumc W Bfamdvk	Wilkowice	Poland

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	31.03.2022
Finland	Not recruiting	31.03.2022
France	Not recruiting	31.03.2022
Germany	Not recruiting	31.03.2022
Greece	Not recruiting	31.03.2022
Hungary	Not recruiting	31.03.2022
Ireland	Not recruiting	31.03.2022
Italy	Not recruiting	31.03.2022
Lithuania	Not recruiting	31.03.2022
Poland	Not recruiting	31.03.2022
Portugal	Not recruiting	31.03.2022
Romania	Not recruiting	31.03.2022
Spain	Not recruiting	31.03.2022
The Netherlands	Not recruiting	31.03.2022

Trial locations

Investigated Drugs:

MK-7684A is an experimental medication being tested in this clinical trial. It is being studied to see if it can help treat extensive-stage small cell lung cancer. This medication is used in combination with other cancer treatments to see if it can improve the overall survival of patients. It is given to patients after they receive a combination of other cancer drugs, and researchers are trying to find out if it works better than another medication called atezolizumab.

Etoposide is a medication used in this trial as part of a combination treatment for extensive-stage small cell lung cancer. It works by interfering with the growth of cancer cells, which are eventually destroyed. Etoposide is often used with other cancer drugs to enhance its effectiveness in treating cancer.

Platinum refers to a group of chemotherapy drugs that contain the metal platinum. In this trial, a platinum-based drug is used alongside etoposide and other medications to treat extensive-stage small cell lung cancer. These drugs work by damaging the DNA of cancer cells, which helps to stop their growth and spread.

Atezolizumab is another medication being tested in this trial. It is an immunotherapy drug that helps the body’s immune system fight cancer. Atezolizumab is used in combination with etoposide and a platinum-based drug to treat extensive-stage small cell lung cancer. The trial aims to compare the effectiveness of atezolizumab with the experimental drug MK-7684A in improving patient survival.

Extensive-stage small-cell lung cancer – This is a type of lung cancer characterized by the rapid growth and spread of small cancerous cells in the lungs. It is called “extensive-stage” when the cancer has spread beyond the lungs to other parts of the body. The disease progresses quickly, often involving the lymph nodes and other organs. Symptoms may include coughing, chest pain, shortness of breath, and fatigue. As the cancer advances, it can lead to more severe respiratory issues and systemic symptoms. The progression is typically aggressive, requiring prompt medical attention.

Trial ID:

2023-503517-30-00

Protocol code:

MK-7684A-008

NCT ID:

NCT05224141

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of MK-7684A, Etoposide, and Platinum Drugs for Patients with Extensive-Stage Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?