Study Comparing Nivolumab and Relatlimab with Chemotherapy to Pembrolizumab with Chemotherapy for Advanced Non-Small Cell Lung Cancer Patients

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC), specifically in its advanced stages, either stage IV or when it has returned after treatment. The study aims to compare two different treatment approaches to see which one helps patients live longer. One group of participants will receive a combination of two medications, nivolumab and relatlimab, along with chemotherapy. The other group will receive pembrolizumab with chemotherapy. These treatments are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The main goal of the study is to determine if the combination of nivolumab and relatlimab with chemotherapy is more effective in extending the lives of patients compared to pembrolizumab with chemotherapy. The study will also look at other factors, such as how long the cancer stays under control and the overall response to the treatments. Participants will be monitored for any side effects from the medications.

The study will take place over several years, with the estimated completion date in 2027. Participants will be randomly assigned to one of the two treatment groups and will receive their assigned treatment as part of the study. The results will help determine the best first-line treatment option for people with this type of lung cancer.

1 joining the study

Upon joining the study, participants will be assigned to one of two groups. Each group will receive a different combination of medications to treat non-small cell lung cancer (NSCLC).

2 treatment group assignment

Participants will be randomly assigned to either Arm A or Arm B. This assignment determines the specific treatment regimen to be followed.

3 treatment in arm a

Participants in Arm A will receive a combination of nivolumab and relatlimab along with chemotherapy. The chemotherapy may include drugs such as pemetrexed disodium, cisplatin, or carboplatin.

All medications will be administered through an intravenous infusion, which means they will be given directly into a vein. The specific dosage and frequency will be determined by the study team.

4 treatment in arm b

Participants in Arm B will receive pembrolizumab along with chemotherapy. The chemotherapy may include drugs such as pemetrexed disodium, cisplatin, or carboplatin.

All medications will be administered through an intravenous infusion. The specific dosage and frequency will be determined by the study team.

5 monitoring and follow-up

Throughout the study, participants will undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects. This will include medical examinations, blood tests, and imaging scans such as CT or MRI.

Participants will be required to attend scheduled visits as determined by the study team.

6 end of study participation

The study is expected to continue until May 2027. Participants will be informed about the end of their participation and any necessary follow-up care.

The main goal of the study is to compare the overall survival of participants in Arm A and Arm B.

Who Can Join the Study?

  • Participants must be men or women who are 18 years or older.
  • They must have a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is either in stage IV or has come back after treatment.
  • This type of cancer must not have been treated with any other cancer drugs before.
  • The cancer cells must have a certain amount of a protein called PD-L1, which will be checked in a lab before the study starts.
  • The cancer must be visible on a CT or MRI scan, and these scans must be done within 32 days before receiving study treatment.
  • Participants should be generally healthy, with a score of 1 or less on a scale that measures how well they can do their daily activities.
  • They should also be expected to live for at least 3 months from the start of the study.

Who Cannot Join the Study?

  • Patients with a type of lung cancer that is not non-squamous (NSQ) Stage IV or Recurrent Non-small Cell Lung Cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Centre hospitalier universitaire de Liege Liege Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Klinikum Wels-Grieskirchen GmbH Wels Austria
Algemeen Ziekenhuis Delta Roeselare Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Radiotherapy Center Cluj S.R.L. Floresti Romania
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Spitalul Municipal Ploiesti Ploiesti Romania
Universitaetsklinikum Krems Krems An Der Donau Austria
Bundeswehrkrankenhaus Ulm Ulm Germany
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Med Polonia Sp. z o.o. Poznan Poland
Institutul Regional De Oncologie Iasi Iasi Romania
Virgen del Rocío University Hospital Sevilla Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Hospital Son Llatzer Palma Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier De La Cote Basque Bayonne France
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
Szpital Specjalistyczny W Prabutach Sp. z o.o. Prabuty Poland
Rigshospitalet Copenhagen Denmark
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Sygehus Soenderjylland Soenderborg Aabenraa Denmark
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Beacon Hospital Dublin Ireland
Onkologie am Raschplatz Dr. Ingo Zander & Dr. Eyck von der Heyde Hanover Germany
Uqmwyaixcakmamiofiiam Eqthx Axw Essen Germany
Ilbbbd Ieevmcqx Ftspwwgudhxka Oxjaaaqwjzy Rome Italy
Ljuzx Uhxbdjkoeuag Mgwvlwr Crhrdku (njchn Leiden The Netherlands
Rriruygjq Zjopaoqhpz Sgwdwlwrf Arnhem The Netherlands
Ijrsldlj Cljkyb Dfezjiywoszcybxmi L'hospitalet De Llobregat Spain
Luq Mwl Oovucdpyw Syv z obar Warsaw Poland
Ergovtfxfgqw Kpvzzhqnawhlyudpxxdtcah Henvfpyolmbodpmissbt gdzey Herne Germany
Awvjubkjym Pmvugyyl Hcvitdcx Dw Mbstvxutv Marseille France
Awijnc Uavolpktic Hfcuhvkg Aarhus Denmark
Csrtdy Hrjxbsuykz E Uyzloppihxiio Dv Chfnoyh Elznub Coimbra Portugal
Ujhxlzlvacnlrdntidhlt Mmlgcitz Anu Munster Germany
Ccnm Dq Nsdpi Vandoeuvre Les Nancy France
Kkoagybd dew Uzbatfgvxzrz Moncpjaj Auo Munich Germany
Hfghzpzq Di Lq Snayo Cugo I Sxly Pkc Barcelona Spain
Uohwqcizqp Ox Azohqmx Edegem Belgium
Htfcgnly Vjrw damaugzw Barcelona Spain
Hvovqrwy Uylectkbkugtq de A Ctemgk A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
30.06.2025
Belgium Belgium
Recruiting
30.06.2025
Denmark Denmark
Recruiting
30.06.2025
France France
Recruiting
30.06.2025
Germany Germany
Recruiting
30.06.2025
Ireland Ireland
Recruiting
30.06.2025
Italy Italy
Recruiting
30.06.2025
Poland Poland
Recruiting
30.06.2025
Portugal Portugal
Recruiting
30.06.2025
Romania Romania
Recruiting
30.06.2025
Spain Spain
Recruiting
30.06.2025
The Netherlands The Netherlands
Recruiting
30.06.2025

Trial locations

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this study, it is used in combination with another medication to see if it can help people with a specific type of lung cancer live longer.

Relatlimab is another immune checkpoint inhibitor. It is used together with nivolumab in a fixed-dose combination. This means both medications are given together in a single treatment. The goal is to enhance the immune system’s ability to fight cancer cells in people with lung cancer.

Pembrolizumab is also an immune checkpoint inhibitor. It helps the immune system target and destroy cancer cells. In this study, it is used alongside chemotherapy to see how well it works compared to the combination of nivolumab and relatlimab with chemotherapy.

Non-squamous Stage IV or Recurrent Non-small Cell Lung Cancer – This type of lung cancer originates in the tissues of the lung, specifically in cells that are not squamous cells. It is classified as Stage IV when it has spread beyond the lungs to other parts of the body, such as the brain, bones, or liver. Recurrent non-small cell lung cancer refers to cancer that has returned after treatment. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with normal lung function. As it advances, it can cause symptoms like persistent cough, chest pain, and difficulty breathing. The spread to other organs can lead to additional symptoms depending on the affected area.

Trial ID:
2024-513682-40-01
Protocol code:
CA2241093
Trial Phase:
Therapeutic confirmatory (Phase III)

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