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Study of BMS-986012 with Chemotherapy 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 a type of lung cancer known as Extensive-Stage Small Cell Lung Cancer (SCLC). The trial is testing a new treatment called BMS-986012, which is a special kind of medicine known as a human IgG1 monoclonal antibody. This medicine is designed to target a specific part of cancer cells. The study will also use standard chemotherapy drugs, cisplatin and etoposide, which are commonly used to treat this type of cancer.

The purpose of the study is to find out how safe and tolerable the new treatment is when used with chemotherapy, and to determine the best dose to use. The study will be conducted in several parts. Initially, participants will receive BMS-986012 along with four cycles of either cisplatin or another similar drug called carboplatin, combined with etoposide. After these cycles, participants will continue to receive BMS-986012 alone until the cancer progresses. In another part of the study, the effectiveness of the combination of BMS-986012 with chemotherapy will be compared to chemotherapy alone.

Participants in the study will be monitored for any side effects and how well the treatment works in controlling the cancer. The study aims to improve understanding of how this new treatment can be used to help people with extensive-stage SCLC. The trial will continue until the estimated end date in 2024, with the goal of providing valuable information on the potential benefits of BMS-986012 for patients with this type of lung cancer.

1 initial treatment phase

The trial begins with the administration of a combination of medications. This includes BMS-986012, a human monoclonal antibody, given through an intravenous injection. The treatment is combined with chemotherapy drugs, either cisplatin or carboplatin, along with etoposide.

This phase involves four cycles of treatment. Each cycle typically lasts for a few weeks, during which the medications are administered according to a specific schedule determined by the healthcare team.

2 monotherapy phase

After completing the initial four cycles, the treatment continues with BMS-986012 alone. This phase is known as monotherapy, where only one medication is used.

The monotherapy phase continues until there is evidence of disease progression, meaning the cancer is no longer responding to the treatment.

3 monitoring and assessment

Throughout the trial, regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking for any adverse events or side effects.

Blood tests and other assessments are performed to measure the concentration of the medication in the body and to monitor the body’s response to the treatment.

4 completion of trial

The trial is estimated to conclude by June 29, 2024. At the end of the trial, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

  • The patient must have Small Cell Lung Cancer that is confirmed by a test called histology or cytology. These are tests that look at cells under a microscope to check for cancer.
  • The cancer must be in an extensive stage, which means it has spread to other parts of the body.
  • The patient must have an ECOG performance status of 0 or 1. This is a scale that measures how well a patient can perform daily activities. A score of 0 means the patient is fully active, and a score of 1 means the patient is restricted in physically strenuous activity but can do light work.
  • The patient must be 18 years of age or older.
  • Both males and females can participate in the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have already received treatment for their lung cancer.
  • Patients who have serious health problems that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures.
  • Patients who have allergies to the study medications.
  • Patients who are participating in another clinical trial.
  • Patients who have had a recent major surgery.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
13.10.2016

Trial locations

Investigated drugs:

BMS-986012 is an experimental medication being tested for its safety and effectiveness in treating extensive-stage small cell lung cancer. In this trial, it is used in combination with other cancer treatments and also as a standalone therapy to see how well it works in stopping the progression of the disease.

Cisplatin is a chemotherapy drug used to treat various types of cancer, including lung cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing.

Etoposide is another chemotherapy medication that is often used in combination with other drugs to treat lung cancer. It helps to stop cancer cells from dividing and growing by interfering with their DNA.

Carboplatin is similar to cisplatin and is used as a chemotherapy treatment for lung cancer. It works by damaging the DNA in cancer cells, which helps to stop their growth and spread.

Investigated diseases:

Extensive-Stage Small Cell Lung Cancer – This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It is called “extensive-stage” when the cancer has spread beyond the lungs to other parts of the body. The disease often progresses rapidly, affecting organs such as the liver, brain, and bones. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer advances, it can lead to more severe respiratory issues and general health decline. The progression of this disease is typically aggressive, requiring prompt medical attention.

Trial ID:
2024-511824-15-00
Protocol code:
CA001-044
NCT ID:
NCT02815592
Trial Phase:
Human Pharmacology (Phase I) – Other

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