Study of Durvalumab and Tremelimumab for Patients with Limited Stage Small-Cell Lung Cancer After Chemoradiation Therapy

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What is this study about?

This clinical trial is focused on studying treatments for Limited Stage Small-Cell Lung Cancer (LS-SCLC). The study will explore the effectiveness of two medications, Durvalumab and Tremelimumab, either used together or with a placebo. Durvalumab is also known by its code name MEDI4736. The purpose of the study is to evaluate how well these treatments work in patients who have not experienced disease progression after receiving a combination of chemotherapy and radiation therapy.

Participants in the study will receive one of the following treatments: Durvalumab alone, a combination of Durvalumab and Tremelimumab, or a placebo. The medications are administered as a solution for infusion, which means they are given directly into the bloodstream through a vein. The study will last for a period of up to 24 months, during which the effects of the treatments will be monitored and compared.

The trial aims to provide valuable information on the potential benefits of these treatments for patients with Limited Stage Small-Cell Lung Cancer. By participating in this study, researchers hope to determine if these medications can help improve the outcomes for patients who have already undergone initial treatment with chemotherapy and radiation. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of limited stage small-cell lung cancer (LS-SCLC) and completion of prior chemoradiotherapy.

A tumor sample is required, which may include a biopsy or other forms of tissue samples. This sample should be submitted before or within 60 days of randomization.

2 randomization

Participants are randomly assigned to receive either durvalumab alone, durvalumab with tremelimumab, or a placebo.

This process ensures that each participant has an equal chance of receiving any of the treatments.

3 treatment administration

The treatment involves intravenous administration of the assigned medication. Durvalumab and tremelimumab are given as a solution for infusion.

The frequency and dosage are determined by the study protocol and are administered under medical supervision.

4 monitoring and assessments

Regular monitoring is conducted to assess the treatment’s effectiveness and safety. This includes physical examinations, blood tests, and imaging studies.

Participants are evaluated for progression-free survival (PFS) and overall survival (OS) as primary outcomes.

5 completion of treatment

The treatment phase concludes as per the study’s timeline or if specific criteria are met, such as disease progression.

Participants may continue to be monitored for long-term outcomes and any potential side effects.

Who Can Join the Study?

  • Patients must have Limited Stage Small-Cell Lung Cancer (LS-SCLC), which means the cancer is in a limited area and can be treated with radiation.
  • The cancer must be confirmed through a test called histology or cytology, which examines cells or tissues under a microscope.
  • Patients should have received a specific type of treatment called chemoradiotherapy, which combines chemotherapy and radiation therapy.
  • The chemotherapy must include a drug called platinum and another drug called etoposide, given through a vein (IV).
  • Radiation therapy should have started by the end of the second cycle of chemotherapy and must meet specific dose requirements.
  • Patients must have shown a positive response to the treatment, such as complete response (CR), partial response (PR), or stable disease (SD), and the cancer should not have worsened.
  • Patients need to have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • A sample of the tumor must be available for testing, which can be obtained through various methods like a needle biopsy.
  • Patients can be of any gender.
  • Patients must be within the age range specified by the study.
  • Patients from vulnerable populations may be included in the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Limited Stage Small-Cell Lung Cancer (LS-SCLC) cannot participate. LS-SCLC is a specific type of lung cancer that is still in its early stages.
  • Individuals who are not within the specified age range for the study are excluded. The study has specific age requirements that participants must meet.
  • Participants who are not able to follow the study procedures or who have conditions that might interfere with the study results are not eligible.
  • People who are part of a vulnerable population, which means they might need special protection or care, are not allowed to join the study.
  • Anyone who has a medical condition or is taking medication that could affect the study’s outcome cannot participate.
  • Individuals who have previously received certain treatments that might interfere with the study are excluded.
  • Participants who are pregnant or breastfeeding are not eligible to join the study.
  • People who have a history of severe allergic reactions to any of the study medications are not allowed to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Institut Jules Bordet Anderlecht Belgium
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Azienda Ospedaliera S Maria Di Terni Terni Italy
Asklepios Klinik Gauting GmbH Gauting Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Algemeen Ziekenhuis Delta Roeselare Belgium
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Ziekenhuis St Jansdal Harderwijk The Netherlands
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie Munster Germany
Nemocnice AGEL Ostrava-Vitkovice a.s. Ostrava Czechia
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o. Tomaszow Mazowiecki Poland
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Kliniken der Stadt Koeln gGmbH Cologne Germany
Jessa Ziekenhuis Hasselt Belgium
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
Ctkazlyhj Udjdrgjihbisly Sgoboojwk Woluwe-Saint-Lambert Belgium
Ujavokoyfhsk Mbcwclc Csxvuit Gxbrupfsb Groningen The Netherlands
Dcmzalumzbhy Cqfsfgq Oothggcjw Pfsamozxbiyj I Hmxcujwiscc Wroclaw Poland
Ojhfhdfppmraisjyxfhzdcmnwy Aalst Belgium
Amfipuktr Uuj Amsterdam The Netherlands
Nkxhgbut Iowflmjy Oldaobqfc Iji Mobao Sojzdsuhyhyhsfyjedmgskgdpogm Ijohkpkx Btbgtahk Cracow Poland
Uvgtgrxwsonpzwxlezfrt Wsdkrzqef Aeg Wuerzburg Germany
Ukvyrghkhjhmqz Clbppyj Kskujlbtj Gdansk Poland
Htkdlayo Vtxp dvdkwwla Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
03.06.2024
Czechia Czechia
Not recruiting
03.06.2024
Germany Germany
Not recruiting
03.06.2024
Italy Italy
Not recruiting
03.06.2024
Poland Poland
Not recruiting
03.06.2024
Spain Spain
Not recruiting
03.06.2024
The Netherlands The Netherlands
Not recruiting
03.06.2024

Trial locations

Durvalumab is a medication used in this clinical trial as a consolidation treatment for patients with limited-stage small-cell lung cancer. It is being tested to see if it can help prevent the cancer from progressing after the patients have received chemoradiation therapy. Durvalumab works by helping the immune system recognize and attack cancer cells more effectively.

Tremelimumab is another medication being studied in combination with Durvalumab in this trial. It is also used as a consolidation treatment for small-cell lung cancer. Tremelimumab is designed to enhance the body’s immune response against cancer cells, potentially improving the effectiveness of the treatment when used alongside Durvalumab.

Limited Stage Small-Cell Lung Cancer (LS-SCLC) – This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It is called “limited stage” when the cancer is confined to one side of the chest and can be treated with a single radiation field. The disease progresses rapidly, often spreading to other parts of the body if not treated promptly. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer grows, it can cause additional symptoms such as weight loss and fatigue. Early detection and intervention are crucial to managing the disease effectively.

Trial ID:
2023-509602-29-00
Protocol code:
D933QC00001
NCT ID:
NCT03703297
Trial Phase:
Therapeutic confirmatory (Phase III)

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