Study Comparing BMS-986489 with Chemotherapy to Atezolizumab with Chemotherapy for First-Line Treatment in Patients with Extensive-Stage Small Cell Lung Cancer

3 1 1 1

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 aims to compare two different treatment combinations to see which one helps patients live longer. One group of participants will receive a combination of BMS-986489 (a fixed dose combination of BMS-986012 and nivolumab) along with chemotherapy drugs carboplatin and etoposide. The other group will receive atezolizumab with the same chemotherapy drugs.

The purpose of this study is to determine if the combination of BMS-986489 with chemotherapy is more effective than atezolizumab with chemotherapy in treating ES-SCLC. Participants will be randomly assigned to one of the two treatment groups. The study will monitor how long participants live after starting the treatment, as well as other factors like how long it takes for symptoms to worsen, the safety of the treatments, and how well the tumors respond to the treatments.

Throughout the study, participants will receive their treatments through an intravenous (IV) infusion, which means the medicine will be given directly into a vein. The study will continue until the estimated end date in 2031, with the goal of providing valuable information on the effectiveness and safety of these treatment combinations for people with ES-SCLC.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of extensive-stage small cell lung cancer (ES-SCLC).

Eligibility is determined based on the ability to perform normal activities with little or no help, as assessed by the ECOG performance scale.

At least one tumor must be measurable using imaging techniques like a CT scan or MRI, excluding the brain and nervous system.

2 randomization

Participants are randomly assigned to one of two treatment groups.

One group receives BMS-986489 (a combination of BMS-986012 and nivolumab) with chemotherapy.

The other group receives atezolizumab with chemotherapy.

3 treatment administration

Treatment is administered intravenously as a solution for injection.

The chemotherapy regimen includes carboplatin and etoposide.

The specific dosage and frequency of administration are determined by the study protocol and medical team.

4 monitoring and follow-up

Participants are monitored for overall survival, which is the primary endpoint of the study.

Secondary endpoints include the time for disease-related symptoms to worsen, safety (including side effects), tumor response, duration of response, and progression-free survival.

Regular follow-up visits are scheduled to assess these outcomes and ensure participant safety.

5 study completion

The study is estimated to end on August 31, 2031.

Participants will continue to be monitored until the study’s conclusion to gather comprehensive data on the treatment’s effectiveness and safety.

Who Can Join the Study?

  • Must have a diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). This is a type of lung cancer that has spread widely in the body.
  • Must be healthy enough to do normal activities with little or no help. This is based on the ECOG performance scale, which is a way to measure how well a person can perform daily activities.
  • Must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI. These are types of scans that create detailed pictures of the inside of the body. The tumor must be located in a place other than the brain and nervous system.
  • Both men and women can participate in the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than Extensive-Stage Small Cell Lung Cancer (ES-SCLC) cannot participate. This is a specific type of lung cancer that has spread widely in the body.
  • Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not eligible for the specific treatment plan being tested in the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Zentralklinik Bad Berka GmbH Bad Berka Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Klinikum Wels-Grieskirchen GmbH Wels Austria
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Vitaz Sint-Niklaas Belgium
Hospital Universitario De Jaen Jaen Spain
Radiotherapy Center Cluj S.R.L. Floresti Romania
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Henry Dunant Hospital Center Athens Greece
Nemocnice AGEL Ostrava-Vitkovice a.s. Ostrava Czechia
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
General University Hospital Of Larissa Larissa Greece
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital General Universitario De Valencia Valencia Spain
Kliniken der Stadt Koeln gGmbH Cologne Germany
Kepler Universitaetsklinikum GmbH Linz Austria
Pratia S.A. Skorzewo Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A. Peschiera Del Garda Italy
University Hospital Olomouc Olomouc Czechia
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Szpital Specjalistyczny W Prabutach Sp. z o.o. Prabuty Poland
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Centre Hospitalier Lyon Sud Pierre Benite France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
Les Hopitaux Nord-Ouest Villefranche sur Saône France
Cvtsxsypy Ukylhqayipexta Slzawtyuv Woluwe-Saint-Lambert Belgium
Ixmupv Ivulhhpp Fqknayzretkrc Owvzmwsxbbv Rome Italy
Roxenhyzj Zzdcapenet Scrtljllr Arnhem The Netherlands
Uqpofojyzasy Mvszwrd Cqpgsyq Gnwghjeie Groningen The Netherlands
Terajhgpun Cadtuo Hyrfskra Thessaloniki Greece
Lanvv Gmuhedm Hvmydegv Ob Avpjoq Athens Greece
Lwn Fzzqmsjta Ibphtu E at Lzm Rvmryduf Rankweil Austria
Postvvjptof Lnibjneu &qbzuzccnahknzrusnhl Rhftt Kcmceuugalr Konin Poland
Amgslewjy Uxk Amsterdam The Netherlands
Arhidsqjfk Pqhqsrie Hrvsslmf Dy Mdtuqixwm Marseille France
Awfdmx Mwdbzlh Crlvgq Syxq Thessaloniki Greece
Ayjlcdf Uxlbb Swlfpixgg Ljdovm Dt Blbqyez Bologna Italy
Hqaqbhyq Dq La Sxeqq Cxgk I Sazr Psz Barcelona Spain
Iqqmihhx Cpaaw Paris France

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
31.03.2025
Belgium Belgium
Not recruiting
31.03.2025
Czechia Czechia
Not recruiting
31.03.2025
France France
Not recruiting
31.03.2025
Germany Germany
Recruiting
31.03.2025
Greece Greece
Not recruiting
31.03.2025
Italy Italy
Not recruiting
31.03.2025
Poland Poland
Not recruiting
31.03.2025
Romania Romania
Not recruiting
31.03.2025
Spain Spain
Not recruiting
31.03.2025
The Netherlands The Netherlands
Not recruiting
31.03.2025

Trial locations

BMS-986489: This is a combination of two medications, BMS-986012 and Nivolumab, used together as a fixed dose. It is being tested to see if it can help people with extensive-stage small cell lung cancer live longer when used with chemotherapy.

Carboplatin: This is a chemotherapy medication that is used to treat various types of cancer, including lung cancer. It works by stopping the growth of cancer cells.

Etoposide: This is another chemotherapy medication used to treat lung cancer. It works by interfering with the DNA of cancer cells, preventing them from dividing and growing.

Atezolizumab: This is an immunotherapy medication that helps the immune system recognize and attack cancer cells. It is used in combination with chemotherapy to treat extensive-stage small cell lung cancer.

Extensive-Stage Small Cell Lung Cancer (ES-SCLC) – This is a type of lung cancer characterized by the rapid growth and spread of cancer cells in the lungs and potentially to other parts of the body. It is called “extensive-stage” because the cancer has spread beyond the lung to other areas, such as the opposite lung, lymph nodes, or distant organs. The disease progresses quickly, often leading to symptoms like coughing, chest pain, and difficulty breathing. As the cancer advances, it may cause additional symptoms related to the areas it has spread to, such as bone pain or neurological issues. The aggressive nature of this cancer means it can change rapidly, requiring close monitoring.

Trial ID:
2024-515740-23-00
Protocol code:
CA245-0001
NCT ID:
NCT06646276
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study to evaluate the effectiveness of tarlatamab in patients with extensive-stage small cell lung cancer that has progressed after prior treatment and who have limited health status

    Recruiting

    2 1 1
    Investigated drugs:
    France Greece Italy Spain
  • A study of PF-08634404 and a drug combination for adult patients with extensive-stage small cell lung cancer

    Recruiting

    4 1 1 1
    France Germany Italy Spain