Study of BMS-986012, carboplatin, etoposide and nivolumab combination as first treatment for patients with extensive-stage small cell lung cancer

2 1 1 1

What is this study about?

This clinical trial studies a combination treatment for Extensive-stage Small Cell Lung Cancer. The study tests a new treatment approach that combines several medications: BMS-986012 (an experimental antibody), carboplatin, etoposide, and nivolumab. The purpose is to evaluate how safe and effective this combination therapy is compared to standard treatment.

The study involves two different treatment approaches. One group of patients receives all four medications (BMS-986012, carboplatin, etoposide, and nivolumab) for the first part of treatment, followed by continued treatment with BMS-986012 and nivolumab. The other group receives only carboplatin, etoposide, and nivolumab initially, followed by nivolumab alone.

During the study, patients will undergo regular medical examinations and imaging tests such as computed tomography or magnetic resonance imaging to monitor how well the treatment is working. The researchers will track how the cancer responds to treatment and monitor any side effects that may occur. The study will also measure how long patients live without their cancer getting worse and their overall survival time.

1 Initial treatment phase – Induction therapy

You will be randomly assigned to one of two treatment groups (Arm A or Arm B)

The induction phase consists of 4 treatment cycles with the following medications:

Arm A receives: carboplatin, etoposide, nivolumab, and BMS-986012 – all given as intravenous infusions

Arm B receives: carboplatin, etoposide, and nivolumab – all given as intravenous infusions

2 Maintenance treatment phase

After completing the 4 cycles of induction therapy, you will continue with maintenance treatment:

Arm A continues with: BMS-986012 and nivolumab infusions

Arm B continues with: nivolumab infusions only

3 Monitoring and evaluation

Your condition will be monitored through regular imaging scans (CT or MRI)

Healthcare providers will track any side effects or reactions to the treatment

Treatment response will be evaluated using standardized criteria (RECIST v1.1)

Blood tests will be performed to check your body’s response to the medications

4 Study duration

The study continues from March 2021 to December 2026

Your participation duration will depend on how your body responds to the treatment

Regular assessments will determine if you should continue with the treatment

Who Can Join the Study?

  • Must be an adult aged 18 years or older
  • Must have a good physical condition, measured by ECOG performance status of 0 or 1 (meaning able to perform all or most daily activities without assistance)
  • Must have at least one tumor that can be measured using CT scan (detailed X-ray imaging) or MRI (magnetic imaging) according to specific measurement criteria called RECIST v1.1
  • Must have adequate blood cell counts and proper functioning of vital organs (such as liver and kidneys)
  • Must be willing and able to use effective birth control methods during the study if capable of having children
  • Both men and women may participate in the study

Who Cannot Join the Study?

  • History of previous treatments with anti-cancer therapy for extensive-stage small cell lung cancer
  • Active brain metastases (cancer spread to the brain) or spinal cord compression that is not fully treated
  • Other types of cancer within the last 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Serious heart conditions in the past 6 months, including heart attack, unstable angina, or heart failure
  • Active autoimmune disease that requires systemic treatment
  • History of organ transplantation
  • Previous severe allergic reactions to study medications or similar compounds
  • Pregnancy or breastfeeding
  • Any condition that, in the investigator’s opinion, would interfere with the safety of the participant
  • Unable to give informed consent or follow study procedures
  • Current participation 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
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Grand Hopital De Charleroi Charleroi Belgium
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
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
Metropolitan Hospital Athens Greece
Rruwxzjei Zyzdpmjpeo Sfyvzmhzq Arnhem The Netherlands
Uodaxrgsycyo Mgsdyra Cdhsbat Gifjbixaw Groningen The Netherlands
Lpyvb Gjgrgma Hctuzgrk Ow Awvsza Athens Greece
Adtajoeav Ula Amsterdam The Netherlands
Uwsbukhqajpubd Cxbsxxl Kvrjsnpsi Gdansk Poland
Hwjgsxro Vhox dhweyptz 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
17.03.2021
Greece Greece
Not recruiting
17.03.2021
Italy Italy
Not recruiting
17.03.2021
Poland Poland
Not recruiting
17.03.2021
Romania Romania
Not recruiting
17.03.2021
Spain Spain
Not recruiting
17.03.2021
The Netherlands The Netherlands
Not recruiting
17.03.2021

Trial locations

BMS-986012 is an investigational medication being studied for the treatment of small cell lung cancer. It is being tested in combination with other cancer medications as a first-line treatment.

Carboplatin is a chemotherapy medication commonly used to treat various types of cancer. It works by interfering with cancer cell growth and division.

Etoposide is another chemotherapy medication that works by blocking an enzyme needed for cancer cell growth. It is often used in combination with other cancer treatments.

Nivolumab is an immunotherapy medication that helps the body’s immune system recognize and fight cancer cells. It works by blocking a protein that prevents T-cells (immune cells) from attacking cancer cells.

Small Cell Lung Cancer (Extensive Stage) – A fast-growing type of lung cancer that typically starts in the bronchi, the large airways in the center of the chest. It is characterized by small, round cancer cells that form into masses and spread quickly to other parts of the body. In extensive stage, the cancer has spread beyond one lung and nearby lymph nodes to other parts of the body. The disease often develops in people with a history of smoking and can cause symptoms such as persistent cough, chest pain, and difficulty breathing. Small cell lung cancer can spread rapidly to the lymph nodes, liver, bones, brain, and other organs.

Trial ID:
2024-510700-36-00
Protocol code:
CA001-050
NCT ID:
NCT04702880
Trial Phase:
Therapeutic exploratory (Phase II)

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