Study of Relatlimab and Nivolumab with Chemotherapy for Patients with Stage IV or Recurrent Non-Small Cell Lung Cancer

2 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for , which is a type of lung cancer. The study involves two main treatments: and , both of which are given through an intravenous infusion, meaning they are delivered directly into the bloodstream. These treatments are being tested in combination with various chemotherapy drugs, including , , , , and . The purpose of the study is to compare the effectiveness of Relatlimab plus Nivolumab with chemotherapy against Nivolumab with chemotherapy in patients with advanced or recurrent NSCLC.

Participants in the study will receive either the combination of Relatlimab and Nivolumab with chemotherapy or Nivolumab with chemotherapy. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment each participant is receiving. This helps ensure that the results are not biased. The study will take place over a period of time, with regular monitoring to assess the safety and effectiveness of the treatments. Participants will be closely observed for any side effects or changes in their condition.

The study aims to provide valuable information on how these treatments work together and their potential benefits for people with stage IV or recurrent NSCLC. By participating, individuals contribute to research that may improve future treatment options for this type of lung cancer. The trial will help determine if the combination of Relatlimab and Nivolumab with chemotherapy offers a better outcome compared to the current standard treatment of Nivolumab with chemotherapy.

1 initial treatment phase

The treatment begins with the administration of nivolumab and relatlimab through an intravenous infusion. The dosage of relatlimab is either 360 mg or 720 mg, depending on the specific group assignment.

This phase also includes chemotherapy, which may involve drugs such as cisplatin, pemetrexed disodium, paclitaxel, carboplatin, or paclitaxel albumin-bound. These medications are administered via intravenous infusion as well.

2 monitoring and assessment

Regular monitoring is conducted to evaluate the body’s response to the treatment. This includes imaging tests like computed tomography (CT) or magnetic resonance imaging (MRI) to measure the size of the tumor.

The assessment follows the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, which helps in determining the effectiveness of the treatment.

3 continuation or adjustment of treatment

Based on the initial response and any side effects experienced, the treatment plan may be continued or adjusted. This decision is made to optimize the effectiveness of the therapy while minimizing adverse effects.

The primary goal is to evaluate the occurrence of treatment-related adverse events (TRAEs) that might lead to discontinuation within the first 12 weeks.

4 ongoing evaluation

Throughout the trial, ongoing evaluations are conducted to monitor the overall response rate (ORR) and progression-free survival (PFS) using the RECIST criteria.

These evaluations help in understanding the long-term benefits and risks associated with the treatment regimen.

5 completion of trial

The trial is estimated to conclude by July 2025. At the end of the trial, a comprehensive analysis of the data collected will be performed to determine the overall efficacy and safety of the treatment combinations.

Who Can Join the Study?

Participants must be males or females who are 18 years or older.
Participants must have non-small cell lung cancer (NSCLC) that is metastatic (spread to other parts of the body) or has come back after treatment for locally advanced disease. The cancer can be of squamous or non-squamous type.
The disease must be measurable using imaging tests like CT scans or MRI. These tests should be done within 28 days before joining the study.
Participants should not have received any systemic anti-cancer treatment as the main therapy for advanced or metastatic disease.
Participants must have an ECOG performance status of 1 or less. This is a scale that measures how well a person can perform daily activities.
Participants should have a life expectancy of at least 3 months at the time of the first dose.
A tissue sample from a previous biopsy or surgery must be available. This sample should be sent to a central laboratory for testing.
Participants must have results from a PD-L1 immunohistochemistry (IHC) test from a central laboratory during the screening period before joining the study. This test checks for a specific protein in the cancer cells.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Non-Small Cell Lung Cancer cannot participate. This type of cancer affects the lungs and is not the same as other lung cancers.
Patients who have not been diagnosed with Stage IV or recurrent Non-Small Cell Lung Cancer are excluded. Stage IV means the cancer has spread to other parts of the body, and recurrent means it has come back after treatment.
Patients who are not able to safely receive the study medications, such as nivolumab or relatlimab, are not eligible. These are specific drugs used in the study.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are not able to follow the study procedures or attend the required visits are excluded. This means they need to be able to come to appointments and follow instructions.
Patients who are part of a vulnerable population that the study cannot safely include are not eligible. This means people who might be at higher risk for complications.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centr Georges Francois Leclerc	Dijon	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland
Show more
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Onco Clinic Consult S.A.	Craiova	Romania
Universitair Ziekenhuis Gent	Gent	Belgium
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Az Maria Middelares Gent	Gent	Belgium
Oncolab S.R.L.	Craiova	Romania
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Ziekenhuis St Jansdal	Harderwijk	The Netherlands
Azienda Ospedaliera Ospedali Riuniti Marche Nord	Pesaro	Italy
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Centre Hospitalier Le Mans	Le Mans	France
Philipps-Universitaet Marburg	Marburg	Germany
Oncocenter Oncologie Clinica S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
St Vincent’s University Hospital	Dublin	Ireland
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Studienzentrum Onkologie Ravensburg GmbH	Ravensburg	Germany
Beaumont Hospital	Dublin	Ireland
Mandziuk Slawomir – Specjalistyczna Praktyka Lekarska	Lublin	Poland
Rngqofdaa Ztotrufdth Szxvfsrfx	Arnhem	The Netherlands
Npntbjyi Ifdhntgj Ogccdqotg Ijf Mxvbm Svusdfwlgzkrffqupwovrhwykban Iqnxmydh Bhtzjbxu	Cracow	Poland
Hvcqjzcw Df Li Spmcu Chct I Stii Ppp	Barcelona	Spain
Imdtgbfx Cejing Debaennaesthuvgfp	L'hospitalet De Llobregat	Spain
Fescplnmr Pnzs Lc Ihmbajavzxyvu Bzpuubktu Dpm Huewuvgw Uvoghljrxzuyd Ll Poc	Madrid	Spain
Kouwyqwn Eiafhtuouuszusxgxpwxnvzx Hpfejaccwyvyvjbxp	Essen	Germany
Hsdttkku Vcaq drttszfe	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	19.05.2021
France	Not recruiting	19.05.2021
Germany	Not recruiting	19.05.2021
Ireland	Not recruiting	19.05.2021
Italy	Not recruiting	19.05.2021
Poland	Not recruiting	19.05.2021
Romania	Not recruiting	19.05.2021
Spain	Not recruiting	19.05.2021
The Netherlands	Not recruiting	19.05.2021

Trial locations

Investigated drugs:

Relatlimab is an experimental medication being studied for its potential to help the immune system fight cancer. It is being tested in combination with other treatments to see if it can improve outcomes for patients with advanced or recurrent non-small cell lung cancer.

Nivolumab is a medication that helps the immune system attack cancer cells. It is used in this study to see if it can be more effective when combined with other treatments for patients with advanced or recurrent non-small cell lung cancer.

Chemotherapy is a type of cancer treatment that uses drugs to kill cancer cells. In this study, it is used in combination with other medications to see if it can improve treatment outcomes for patients with advanced or recurrent non-small cell lung cancer.

Investigated diseases:

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. Early stages may not show significant symptoms, making it challenging to detect without medical screening.

Trial ID:

2023-508372-10-00

Protocol code:

CA224-104

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Relatlimab and Nivolumab with Chemotherapy for Patients with Stage IV or Recurrent Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?