Study of BMS-986315 and Nivolumab with Chemotherapy for First-line Treatment in Stage IV or Recurrent Non-Small Cell Lung Cancer Patients

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What is this study about?

This clinical trial is focused on studying treatments for Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer. The study involves a new treatment called BMS-986315 and another medication known as Nivolumab. These treatments will be used in combination with chemotherapy, which is a common cancer treatment that uses drugs to kill cancer cells. The chemotherapy drugs involved in this study include Cisplatin, Paclitaxel, Carboplatin, and Pemetrexed Disodium. The purpose of the study is to compare the effectiveness of the combination of BMS-986315 and Nivolumab with chemotherapy against the combination of Nivolumab and chemotherapy alone.

The study will be conducted in two parts. The first part will focus on assessing the safety of the combination of BMS-986315 and Nivolumab with chemotherapy. Safety in this context means checking for any side effects or adverse reactions that participants might experience. The second part will compare how well the treatments work in reducing the size of tumors, which is referred to as the objective response rate. This will help determine if the new combination treatment is more effective than the existing treatment option.

Participants in the study will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of time, with some participants receiving treatment for up to 24 months. The results will be carefully monitored and reviewed by a team of experts to ensure the safety and effectiveness of the treatments being tested. This study aims to provide valuable information that could lead to improved treatment options for people with advanced or recurrent NSCLC.

1 joining the study

Upon joining the study, participants will be informed about the trial’s purpose, procedures, and potential risks and benefits. Participants will be required to sign an informed consent form, confirming their understanding and willingness to participate.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and necessary tests to ensure the participant meets the study criteria.

3 treatment phase part 1

In the first part of the treatment phase, participants will receive a combination of BMS-986315 and nivolumab along with chemotherapy. The chemotherapy will be based on the participant’s specific type of lung cancer.

The medications will be administered through an intravenous infusion, which means they will be given directly into a vein. The frequency and dosage will be determined by the study protocol and the participant’s response to the treatment.

4 monitoring and safety checks

Throughout the treatment, participants will be closely monitored for any side effects or adverse reactions. Regular check-ups and tests will be conducted to ensure the participant’s safety and to assess the effectiveness of the treatment.

5 treatment phase part 2

In the second part of the treatment phase, the focus will be on comparing the anti-tumor activity of the combination of BMS-986315 and nivolumab with chemotherapy versus nivolumab with chemotherapy alone.

Participants will continue to receive treatments as per the study protocol, with adjustments made based on their response and any side effects experienced.

6 follow-up

After completing the treatment phase, participants will enter a follow-up period. During this time, regular visits will be scheduled to monitor the participant’s health and to gather data on the long-term effects of the treatment.

Who Can Join the Study?

Participants must be 18 years or older at the time of signing the consent form.
Participants must have Non-small Cell Lung Cancer (NSCLC) that is at Stage IV or has come back after treatment for locally advanced disease.
The study treatment must be the first treatment for Stage IV or recurrent disease.
Participants must have measurable disease according to specific guidelines (RECIST v1.1).
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
Participants must have a life expectancy of at least 3 months at the time of the first dose.

Who Cannot Join the Study?

Patients with any other type of cancer besides Non-small Cell Lung Cancer cannot participate.
Patients who have had a severe allergic reaction to similar medications in the past are not eligible.
Patients with uncontrolled or serious heart conditions cannot join the study.
Patients with active infections that require treatment with antibiotics are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
Patients who have received another investigational drug within the last 4 weeks are excluded.
Patients with a history of drug or alcohol abuse that could interfere with the study are not eligible.
Patients with significant liver or kidney disease cannot participate.
Patients who have had major surgery within the last 4 weeks are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medisprof S.R.L.	Cluj Napoca	Romania
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hospital Santa Maria Della Misericordia	Perugia	Italy
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Med Polonia Sp. z o.o.	Poznan	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Centre Hospitalier De Saint-Quentin	Saint Quentin	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Alsrjpg Okiuhorvmob Uzlctzheejpwb Patgs	Parma	Italy
Iliomb Izwtmxpp Fndwtevxoimhg Otecamolbyq	Rome	Italy
Itawkgok Cwvciu Dxfbedgudekhelekm	L'hospitalet De Llobregat	Spain
Uctenbxrraszsw Chphlut Kwmqfmycd	Gdansk	Poland
Hkxjwbcg Vtdx dzktvyfh	Barcelona	Spain
Ihncosjq Cfhsz	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	17.02.2024
Italy	Not recruiting	17.02.2024
Poland	Not recruiting	17.02.2024
Romania	Not recruiting	17.02.2024
Spain	Not recruiting	17.02.2024

Trial locations

Investigated drugs:

BMS-986315 is an experimental medication being tested to see if it can help treat non-small cell lung cancer. It is being studied to understand how safe it is when used with other cancer treatments and to see if it can help shrink tumors or stop them from growing.

Nivolumab is a medication that helps the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. In this trial, it is used in combination with other treatments to see if it can improve the effectiveness of cancer therapy.

Histology-based platinum doublet chemotherapy (PDCT) is a type of cancer treatment that uses two chemotherapy drugs together. These drugs are chosen based on the specific type of lung cancer a patient has. The goal of this therapy is to kill cancer cells or stop them from growing and spreading.

Investigated diseases:

Non-small Cell Lung Cancer – Non-small Cell Lung Cancer (NSCLC) is a group of lung cancers that behave similarly and are the most common type of lung cancer. It typically begins in the epithelial cells lining the lungs and can spread to other parts of the body. The disease progresses through stages, starting from a localized tumor to more advanced stages where it may invade nearby tissues or spread to distant organs. NSCLC grows at a slower rate compared to small cell lung cancer, allowing for a longer period before symptoms become severe. As the cancer advances, it can cause symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary significantly among individuals, influenced by factors such as the specific subtype and genetic mutations present.

Trial ID:

2022-503007-22-00

Protocol code:

CA0471009

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of BMS-986315 and Nivolumab with Chemotherapy for First-line Treatment in Stage IV or Recurrent Non-Small Cell Lung Cancer Patients

What is this study about?

Who Can Join the Study?

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