A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 1-49%

Phase 3

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Pembrolizumab; Drug: Nivolumab; Drug: Relatlimab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin

• Registration Number: NCT06561386
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 1-49%

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-20
• Study Start: 2024-10-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2030-07-30
• Study Completion: 2033-11-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Pembrolizumab	-
Arm A	Pemetrexed	-
Arm A	Nivolumab	-
Arm A	Relatlimab	-
Arm A	Carboplatin	-
Arm B	Pemetrexed	-
Arm A	Cisplatin	-
Arm B	Carboplatin	-
Arm B	Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 5 years
Overall response rate (ORR)	Up to 5 years
Number of participants with immune-mediated adverse events (IMAEs)	Up to 2.5 years
Number of participants with adverse events (AEs)	Up to 2.5 years
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score	Up to 2 years
Duration of response (DoR)	Up to 5 years
Number of participants with serious adverse events (SAEs)	Up to 2.5 years

Trial Locations

Locations (217)

Saint Elizabeth Medical Center Edgewood; 🇺🇸 Edgewood, Kentucky, United States

Local Institution - 0369; 🇺🇸 Canton, Ohio, United States

Local Institution - 0382; 🇧🇷 Fortaleza, Ceará, Brazil

Local Institution - 0375; 🇧🇷 Belem, Pará, Brazil

Local Institution - 0373; 🇧🇷 São Caetano do Sul, São Paulo, Brazil

Local Institution - 0397; 🇩🇪 Herne, Nordrhein-Westfalen, Germany

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Chungcheongbuk-do [Chungbuk], Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0402; 🇵🇹 Lisbon, Lisboa, Portugal

Local Institution - 0404; 🇵🇹 Coimbra, Portugal

Local Institution - 0401; 🇵🇹 Porto, Portugal

Local Institution - 0111; 🇺🇸 Los Angeles, California, United States

Local Institution - 0112; 🇺🇸 Los Angeles, California, United States

Local Institution - 0403; 🇵🇹 Porto, Portugal

Local Institution - 0408; 🇸🇦 Riyadh, Ar Riyāḑ, Saudi Arabia

Local Institution - 0409; 🇸🇦 Jeddah, Makkah Al Mukarramah, Saudi Arabia

Local Institution - 0398; 🇨🇭 Münsterlingen, Switzerland

Local Institution - 0368; 🇺🇸 Tucson, Arizona, United States

Local Institution - 0304; 🇺🇸 Sacramento, California, United States

Local Institution - 0159; 🇺🇸 San Francisco, California, United States

Local Institution - 0206; 🇺🇸 Miami, Florida, United States

Local Institution - 0162; 🇺🇸 Pembroke Pines, Florida, United States

Local Institution - 0358; 🇺🇸 Saint Petersburg, Florida, United States

Local Institution - 0360; 🇺🇸 West Palm Beach, Florida, United States

Hattiesburg Clinic Hematology/Oncology; 🇺🇸 Hattiesburg, Mississippi, United States

Bozeman Health Deaconess Hospital; 🇺🇸 Bozeman, Montana, United States

Renown Regional Medical Center; 🇺🇸 Reno, Nevada, United States

Local Institution - 0346; 🇺🇸 Paterson, New Jersey, United States

Local Institution - 0381; 🇺🇸 Albuquerque, New Mexico, United States

Local Institution - 0357; 🇺🇸 Bronx, New York, United States

Local Institution - 0356; 🇺🇸 Hawthorne, New York, United States

Local Institution - 0380; 🇺🇸 Northport, New York, United States

Local Institution - 0325; 🇺🇸 Rochester, New York, United States

Local Institution - 0324; 🇺🇸 Syracuse, New York, United States

Local Institution - 0199; 🇺🇸 Cleveland, Ohio, United States

Local Institution - 0366; 🇺🇸 Massillon, Ohio, United States

Local Institution - 0272; 🇺🇸 Lancaster, Pennsylvania, United States

Local Institution - 0359; 🇺🇸 Abilene, Texas, United States

Local Institution - 0305; 🇺🇸 Harlingen, Texas, United States

Local Institution - 0378; 🇺🇸 Houston, Texas, United States

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center; 🇺🇸 Tyler, Texas, United States

Local Institution - 0302; 🇺🇸 Salt Lake City, Utah, United States

Local Institution - 0217; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0236; 🇦🇷 Mar del Plata, Buenos Aires, Argentina

Local Institution - 0219; 🇦🇷 ABB, Ciudad Autónoma De Buenos Aires, Argentina

Local Institution - 0218; 🇦🇷 Río Cuarto, Córdoba, Argentina

Local Institution - 0216; 🇦🇷 Rosario, Santa Fe, Argentina

Local Institution - 0215; 🇦🇷 Córdoba, Argentina

Gosford Hospital; 🇦🇺 Gosford, New South Wales, Australia

Local Institution - 0061; 🇦🇺 St Leonards, New South Wales, Australia

Local Institution - 0243; 🇦🇺 Brisbane, Queensland, Australia

Gallipoli Medical Research Ltd; 🇦🇺 Brisbane, Queensland, Australia

Local Institution - 0057; 🇦🇺 Elizabeth Vale, South Australia, Australia

Local Institution - 0054; 🇦🇺 Box Hill, Victoria, Australia

Local Institution - 0292; 🇦🇹 Wels, Oberösterreich, Austria

Local Institution - 0053; 🇦🇺 Murdoch, Western Australia, Australia

St. John of God Murdoch Hospital; 🇦🇺 Murdoch, Western Australia, Australia

Local Institution - 0314; 🇦🇹 Krems, Niederösterreich, Austria

Local Institution - 0041; 🇧🇪 Roeselare, West-Vlaanderen, Belgium

Local Institution - 0294; 🇦🇹 Feldkirch, Austria

Local Institution - 0293; 🇦🇹 Wien, Austria

Local Institution - 0039; 🇧🇪 Brussels, Bruxelles-Capitale, Région De, Belgium

Local Institution - 0187; 🇧🇪 Hasselt, Limburg, Belgium

Local Institution - 0038; 🇧🇪 Yvoir, Namur, Belgium

Local Institution - 0078; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Local Institution - 0151; 🇧🇷 Natal, Rio Grande Do Norte, Brazil

Local Institution - 0083; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Local Institution - 0076; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Local Institution - 0084; 🇧🇷 Itajaí, Santa Catarina, Brazil

Local Institution - 0152; 🇧🇷 Barretos, São Paulo, Brazil

Local Institution - 0149; 🇧🇷 Bauru, São Paulo, Brazil

Local Institution - 0232; 🇧🇷 Rio de Janeiro, Brazil

Local Institution - 0147; 🇧🇷 São Paulo, Brazil

Local Institution - 0249; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0212; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0214; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0070; 🇨🇳 Beijing, Beijing, China

Local Institution - 0182; 🇨🇳 Hefei, Anhui, China

Local Institution - 0238; 🇨🇳 Chongqing, Chongqing, China

Local Institution - 0244; 🇨🇳 Wanzhou, Chongqing, China

Local Institution - 0075; 🇨🇳 Fuzhou, Fujian, China

Local Institution - 0098; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0307; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0067; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0326; 🇨🇳 Huizhou, Guangdong, China

Local Institution - 0353; 🇨🇳 Liuzhou, Guangxi, China

Local Institution - 0134; 🇨🇳 Nanning, Guangxi, China

Local Institution - 0102; 🇨🇳 Harbin, Heilongjiang, China

Local Institution - 0237; 🇨🇳 Zhengzhou, Henan, China

Local Institution - 0235; 🇨🇳 Wuhan, Hubei, China

Local Institution - 0072; 🇨🇳 Changsha, Hunan, China

Local Institution - 0354; 🇨🇳 Huai'an, Jiangsu, China

Local Institution - 0181; 🇨🇳 Shenyang, Liaoning, China

Local Institution - 0074; 🇨🇳 Jinan, Shandong, China

Local Institution - 0064; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0280; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0318; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0121; 🇨🇳 Chengdu, Sichuan, China

Local Institution - 0177; 🇨🇳 Tianjin, Tianjin, China

Local Institution - 0071; 🇨🇳 Hangzhou, Zhejiang, China

Local Institution - 0099; 🇨🇳 Hangzhou, Zhejiang, China

Local Institution - 0338; 🇨🇳 Hangzhou, Zhejiang, China

Local Institution - 0101; 🇨🇳 Linhai, Zhejiang, China

Local Institution - 0198; 🇩🇰 Aarhus, Midtjylland, Denmark

Local Institution - 0124; 🇩🇰 Soenderborg, Syddanmark, Denmark

Local Institution - 0125; 🇩🇰 Copenhagen, Denmark

Local Institution - 0092; 🇫🇷 Montpellier, Hérault, France

Local Institution - 0093; 🇫🇷 Rennes, Ille-et-Vilaine, France

Local Institution - 0096; 🇫🇷 Lille, Nord-Pas-de-Calais, France

Local Institution - 0091; 🇫🇷 Toulon, Provence-Alpes-Côte-d'Azur, France

Local Institution - 0157; 🇫🇷 Pierre-Bénite, Rhône, France

Local Institution - 0158; 🇫🇷 Marseille, France

Local Institution - 0089; 🇫🇷 Paris, France

Local Institution - 0095; 🇫🇷 Paris, France

Local Institution - 0284; 🇩🇪 Esslingen, Baden-Württemberg, Germany

Local Institution - 0347; 🇩🇪 München, Bayern, Germany

Local Institution - 0283; 🇩🇪 Bad Berka, Thüringen, Germany

Local Institution - 0285; 🇩🇪 Berlin, Germany

Local Institution - 0287; 🇩🇪 Kempten, Bayern, Germany

Local Institution - 0281; 🇩🇪 Frankfurt, Hessen, Germany

Local Institution - 0313; 🇩🇪 Marburg, Hessen, Germany

Local Institution - 0316; 🇩🇪 Grosshansdorf, Schleswig-Holstein, Germany

Local Institution - 0282; 🇩🇪 Bonn, Germany

Local Institution - 0288; 🇩🇪 Essen, Germany

Local Institution - 0286; 🇩🇪 Gauting, Germany

Local Institution - 0317; 🇩🇪 Heidelberg, Germany

Local Institution - 0329; 🇮🇳 New Delhi, Delhi, India

Local Institution - 0337; 🇮🇳 New Delhi, Delhi, India

Local Institution - 0333; 🇮🇳 Bengaluru, Karnataka, India

Local Institution - 0331; 🇮🇳 Thiruvananthapuram, Kerala, India

Local Institution - 0336; 🇮🇳 Mumbai, Maharashtra, India

Local Institution - 0328; 🇮🇳 Howrah, West Bengal, India

Local Institution - 0367; 🇮🇪 Dublin, Ireland

Local Institution - 0029; 🇮🇪 Dublin, Ireland

Local Institution - 0027; 🇮🇪 Dublin, Ireland

Local Institution - 0045; 🇮🇹 Monza, Lombardia, Italy

Local Institution - 0046; 🇮🇹 Naples, Napoli, Italy

Local Institution - 0043; 🇮🇹 Bari, Puglia, Italy

Local Institution - 0250; 🇮🇹 Rome, Roma, Italy

Local Institution - 0221; 🇮🇹 Peschiera del Garda, Verona, Italy

Local Institution - 0312; 🇯🇵 Kashiwa, Chiba, Japan

Local Institution - 0320; 🇯🇵 Kitakyushu, Fukuoka, Japan

Local Institution - 0273; 🇯🇵 Kurume, Fukuoka, Japan

Local Institution - 0276; 🇯🇵 Fukuyama-shi, Hiroshima, Japan

Local Institution - 0311; 🇯🇵 Sapporo, Hokkaido, Japan

Local Institution - 0321; 🇯🇵 Yokohama, Kanagawa, Japan

Local Institution - 0339; 🇯🇵 Sendai, Miyagi, Japan

Local Institution - 0322; 🇯🇵 Kashihara, Nara, Japan

Local Institution - 0279; 🇯🇵 Niigata-shi, Niigata, Japan

Local Institution - 0306; 🇯🇵 Kurashiki, Okayama, Japan

Local Institution - 0275; 🇯🇵 Hirakata, Osaka, Japan

Local Institution - 0277; 🇯🇵 Osaka-sayama, Osaka, Japan

Local Institution - 0274; 🇯🇵 Hidaka, Saitama, Japan

Local Institution - 0278; 🇯🇵 Hamamatsu, Shizuoka, Japan

Local Institution - 0310; 🇯🇵 Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

Local Institution - 0323; 🇯🇵 Koto, Tokyo, Japan

Local Institution - 0327; 🇯🇵 Akashi, Japan

Local Institution - 0319; 🇯🇵 Fukushima, Japan

Local Institution - 0340; 🇯🇵 Osaka, Japan

Local Institution - 0201; 🇰🇷 Goyang-si, Kyǒnggi-do, Korea, Republic of

Local Institution - 0176; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0172; 🇲🇽 Mexico, Distrito Federal, Mexico

Local Institution - 0170; 🇲🇽 Guadalajara, Jalisco, Mexico

Local Institution - 0168; 🇲🇽 Santiago de Queretaro, Querétaro, Mexico

Local Institution - 0169; 🇲🇽 San Luis Potosí, Mexico

Local Institution - 0030; 🇳🇱 Harderwijk, Gelderland, Netherlands

Local Institution - 0193; 🇳🇱 Heerlen, Limburg, Netherlands

Local Institution - 0196; 🇳🇱 Den Bosch, Noord-Brabant, Netherlands

Local Institution - 0195; 🇳🇱 Zwolle, Overijssel, Netherlands

Local Institution - 0036; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Local Institution - 0315; 🇳🇱 The Hague, Zuid-Holland, Netherlands

Local Institution - 0033; 🇳🇱 Arnhem, Netherlands

Local Institution - 0032; 🇳🇱 Groningen, Netherlands

Local Institution - 0259; 🇵🇱 Warsaw, Mazowieckie, Poland

Local Institution - 0258; 🇵🇱 Prabuty, Pomorskie, Poland

Local Institution - 0255; 🇵🇱 Konin, Wielkopolskie, Poland

Local Institution - 0261; 🇵🇱 Poznan, Wielkopolskie, Poland

Local Institution - 0256; 🇵🇱 Skorzewo, Wielkopolskie, Poland

Local Institution - 0257; 🇵🇱 Koszalin, Zachodniopomorskie, Poland

Local Institution - 0260; 🇵🇱 Bydgoszcz, Poland

Local Institution - 0254; 🇵🇱 Łódź, Łódzkie, Poland

Local Institution - 0296; 🇷🇴 Bucharest, București, Romania

Local Institution - 0298; 🇷🇴 Bucharest, București, Romania

Local Institution - 0299; 🇷🇴 Florești, Cluj, Romania

Local Institution - 0295; 🇷🇴 Craiova, Dolj, Romania

Local Institution - 0297; 🇷🇴 Ploiești, Prahova, Romania

Local Institution - 0301; 🇷🇴 Cluj, Romania

Local Institution - 0300; 🇷🇴 Iași, Romania

Local Institution - 0270; 🇪🇸 A Coruña, A Coruña [La Coruña], Spain

Local Institution - 0264; 🇪🇸 Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0267; 🇪🇸 L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain

Local Institution - 0265; 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Local Institution - 0266; 🇪🇸 Málaga, Spain

Local Institution - 0268; 🇪🇸 Sevilla, Spain

Local Institution - 0269; 🇪🇸 València, Spain

Local Institution - 0289; 🇨🇭 st.Gallen, Sankt Gallen, Switzerland

Local Institution - 0341; 🇨🇭 Bellinzona, Ticino, Switzerland

Local Institution - 0291; 🇨🇭 Lausanne, Vaud, Switzerland

Local Institution - 0290; 🇨🇭 Basel, Switzerland

Local Institution - 0118; 🇨🇳 New Taipei, Taiwan

Local Institution - 0117; 🇨🇳 Taichung, Taiwan

Local Institution - 0116; 🇨🇳 Taipei, Taiwan

Local Institution - 0119; 🇨🇳 Taipei, Taiwan

Local Institution - 0361; 🇹🇷 Adana, Turkey

Local Institution - 0365; 🇹🇷 Adana, Turkey

Local Institution - 0383; 🇹🇷 Ankara, Turkey

Local Institution - 0362; 🇹🇷 Ankara, Turkey

Local Institution - 0364; 🇹🇷 Istanbul, Turkey

Local Institution - 0271; 🇬🇧 Larbert, Falkirk, United Kingdom

Local Institution - 0189; 🇬🇧 Glasgow, Glasgow City, United Kingdom

Local Institution - 0021; 🇬🇧 London, Kensington And Chelsea, United Kingdom

Local Institution - 0348; 🇬🇧 London, London, City Of, United Kingdom

Local Institution - 0001; 🇬🇧 London, London, City Of, United Kingdom

Local Institution - 0020; 🇬🇧 Manchester, United Kingdom

Local Institution - 0024; 🇬🇧 Wirral, United Kingdom