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 Expression ≥ 1%
Launched by BRISTOL-MYERS SQUIBB · Aug 16, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different treatments for patients with stage IV or recurrent non-squamous non-small cell lung cancer, specifically those whose tumors have a certain level of PD-L1 expression (between 1% and 49%). Researchers want to see how effective a combination of two drugs, Nivolumab and Relatlimab, plus chemotherapy, is compared to Pembrolizumab with chemotherapy. The goal is to find out which treatment helps patients live longer or feel better.
To be eligible for this trial, participants must be adults aged 65 to 74, have a confirmed diagnosis of stage IV or recurrent non-squamous non-small cell lung cancer, and meet specific health criteria, like having measurable disease and a good performance status. Participants cannot have certain genetic mutations or previous treatments that might interfere with the study. Those who join can expect to receive either treatment for their cancer and will be closely monitored by healthcare professionals throughout the study. This trial is currently recruiting participants, and it’s an important opportunity for patients looking for new treatment options.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
- • Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.
- • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
- • Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
- • Participants must have a life expectancy of at least 3 months at the time of randomization.
- • Exclusion Criteria
- • Participants must not be pregnant and/or breastfeeding.
- • Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.
- • Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.
- • Participants must not have untreated central nervous system (CNS) metastases.
- • Participants must not have leptomeningeal metastases (carcinomatous meningitis).
- • Participants must not have concurrent malignancy requiring treatment.
- • Participants must not have an active autoimmune disease.
- • Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management.
- • Participants must not have a history of myocarditis.
- • Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
- • Other protocol-defined Inclusion/Exclusion criteria apply.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Box Hill, Victoria, Australia
Pembroke Pines, Florida, United States
Houston, Texas, United States
Cincinnati, Ohio, United States
Reno, Nevada, United States
London, , United Kingdom
Gosford, New South Wales, Australia
Paterson, New Jersey, United States
Sapporo, Hokkaido, Japan
Taipei, , Taiwan
San Francisco, California, United States
Hamamatsu, Shizuoka, Japan
Albuquerque, New Mexico, United States
Taichung, , Taiwan
Rosario, Santa Fe, Argentina
Kurume, Fukuoka, Japan
Guangzhou, Guangdong, China
Porto Alegre, Rio Grande Do Sul, Brazil
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Niigata Shi, Niigata, Japan
Kurashiki, Okayama, Japan
Brisbane, Queensland, Australia
Seoul, , Korea, Republic Of
Cleveland, Ohio, United States
Fukushima, , Japan
Kashihara, Nara, Japan
Porto Alegre, Rio Grande Do Sul, Brazil
Asheville, North Carolina, United States
Goyang Si, , Korea, Republic Of
Hangzhou, Zhejiang, China
Liuzhou, Guangxi, China
Taipei, , Taiwan
Murdoch, Western Australia, Australia
Changsha, Hunan, China
Hidaka, Saitama, Japan
Harbin, Heilongjiang, China
Beijing, Beijing, China
Shanghai, Shanghai, China
Saint Petersburg, Florida, United States
Santa Monica, California, United States
Linhai, Zhejiang, China
Yokohama, Kanagawa, Japan
Chengdu, Sichuan, China
Jinan, Shandong, China
Osaka, , Japan
Murdoch, Western Australia, Australia
Cheongju Si, , Korea, Republic Of
Tianjin, Tianjin, China
Kitakyushu, Fukuoka, Japan
Bozeman, Montana, United States
Shenyang, Liaoning, China
Larbert, Falkirk, United Kingdom
Hirakata, Osaka, Japan
West Palm Beach, Florida, United States
Chengdu, , China
Fuzhou, Fujian, China
Tyler, Texas, United States
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Mar Del Plata, , Argentina
Chongqing, Chongqing, China
Zhengzhou, Henan, China
Shenyang, , China
Goyang Si, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Shanghai, Shanghai, China
Chicago Ridge, Illinois, United States
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Edgewood, Kentucky, United States
St Leonards, New South Wales, Australia
Huai'an, Jiangsu, China
Santiago, , Chile
Itajaí, Santa Catarina, Brazil
Barretos, São Paulo, Brazil
Xi'an, Shaanxi, China
São Paulo, , Brazil
Namdong Gu, , Korea, Republic Of
Neijiang, Sichuan, China
Río Cuarto, , Argentina
Huizhou, Guangdong, China
Miami, Florida, United States
London, London, City Of, United Kingdom
Koto, Tokyo, Japan
New Taipei, , Taiwan
Cheongju Si, Chungcheongbuk Do [Chungbuk], Korea, Republic Of
Dundee, Dundee City, United Kingdom
Viña Del Mar, , Chile
Hattiesburg, Mississippi, United States
Nagaizumi Cho,Sunto Gun, Shizuoka, Japan
Río Cuarto, Córdoba, Argentina
Rio De Janeiro, , Brazil
St Leonards, New South Wales, Australia
Hangzhou, Zhejiang, China
Namdong Gu, , Korea, Republic Of
Viña Del Mar, Valparaíso, Chile
Abb, Ciudad Autónoma De Buenos Aires, Argentina
Osaka Sayama, Osaka, Japan
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Wanzhou, Chongqing, China
Brisbane, Queensland, Australia
Guangzhou, Guangdong, China
São Caetano Do Sul, São Paulo, Brazil
Los Angeles, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Francisco, California, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Edgewood, Kentucky, United States
Hattiesburg, Mississippi, United States
Bozeman, Montana, United States
Reno, Nevada, United States
Paterson, New Jersey, United States
Rochester, New York, United States
Cleveland, Ohio, United States
Lancaster, Pennsylvania, United States
Harlingen, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
Abb, Ciudad Autónoma De Buenos Aires, Argentina
Río Cuarto, Córdoba, Argentina
Rosario, Santa Fe, Argentina
Córdoba, , Argentina
Gosford, New South Wales, Australia
Brisbane, Queensland, Australia
Elizabeth Vale, South Australia, Australia
Box Hill, Victoria, Australia
Murdoch, Western Australia, Australia
Krems, Niederösterreich, Austria
Wels, Oberösterreich, Austria
Feldkirch, , Austria
Wien, , Austria
Brussels, Bruxelles Capitale, Région De, Belgium
Hasselt, Limburg, Belgium
Yvoir, Namur, Belgium
Roeselare, West Vlaanderen, Belgium
Natal, Rio Grande Do Norte, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Barretos, São Paulo, Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Hefei, Anhui, China
Beijing, Beijing, China
Chongqing, Chongqing, China
Wanzhou, Chongqing, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Huizhou, Guangdong, China
Nanning, Guangxi, China
Harbin, Heilongjiang, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Changsha, Hunan, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Chengdu, Sichuan, China
Tianjin, Tianjin, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Linhai, Zhejiang, China
Aarhus, Midtjylland, Denmark
Soenderborg, Syddanmark, Denmark
Copenhagen, , Denmark
Montpellier, Hérault, France
Rennes, Ille Et Vilaine, France
Lille, Nord Pas De Calais, France
Toulon, Provence Alpes Côte D'azur, France
Pierre Bénite, Rhône, France
Marseille, , France
Paris, , France
Paris, , France
Esslingen, Baden Württemberg, Germany
Kempten, Bayern, Germany
München, Bayern, Germany
Frankfurt, Hessen, Germany
Marburg, Hessen, Germany
Grosshansdorf, Schleswig Holstein, Germany
Bad Berka, Thüringen, Germany
Berlin, , Germany
Bonn, , Germany
Essen, , Germany
Gauting, , Germany
Heidelberg, , Germany
New Delhi, Delhi, India
New Delhi, Delhi, India
Bengaluru, Karnataka, India
Thiruvananthapuram, Kerala, India
Mumbai, Maharashtra, India
Howrah, West Bengal, India
Monza, Lombardia, Italy
Naples, Napoli, Italy
Bari, Puglia, Italy
Rome, Roma, Italy
Peschiera Del Garda, Verona, Italy
Kashiwa, Chiba, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Fukuyama, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Yokohama, Kanagawa, Japan
Sendai, Miyagi, Japan
Kashihara, Nara, Japan
Niigata Shi, Niigata, Japan
Kurashiki, Okayama, Japan
Hirakata, Osaka, Japan
Osaka Sayama, Osaka, Japan
Hidaka, Saitama, Japan
Hamamatsu, Shizuoka, Japan
Nagaizumi Cho,Sunto Gun, Shizuoka, Japan
Koto, Tokyo, Japan
Akashi, , Japan
Fukushima, , Japan
Osaka, , Japan
Cheongju Si, Chungcheongbuk Do [Chungbuk], Korea, Republic Of
Namdong Gu, , Korea, Republic Of
Goyang Si, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Harderwijk, Gelderland, Netherlands
Heerlen, Limburg, Netherlands
Den Bosch, Noord Brabant, Netherlands
Zwolle, Overijssel, Netherlands
Leiden, Zuid Holland, Netherlands
The Hague, Zuid Holland, Netherlands
Arnhem, , Netherlands
Groningen, , Netherlands
Warsaw, Mazowieckie, Poland
Prabuty, Pomorskie, Poland
Konin, Wielkopolskie, Poland
Poznan, Wielkopolskie, Poland
Skorzewo, Wielkopolskie, Poland
Koszalin, Zachodniopomorskie, Poland
Bydgoszcz, , Poland
łódź, łódzkie, Poland
Bucharest, Bucuresti, Romania
Bucharest, București, Romania
Florești, Cluj, Romania
Craiova, Dolj, Romania
Ploiești, Prahova, Romania
Cluj, , Romania
Iași, , Romania
A Coruña, A Coruña [La Coruña], Spain
Barcelona, Barcelona [Barcelona], Spain
L'hospitalet De Llobregat, Catalunya [Cataluña], Spain
Madrid, Madrid, Comunidad De, Spain
Málaga, , Spain
Sevilla, , Spain
València, , Spain
St.Gallen, Sankt Gallen, Switzerland
Lausanne, Vaud, Switzerland
Basel, , Switzerland
New Taipei, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Larbert, Falkirk, United Kingdom
Glasgow, Glasgow City, United Kingdom
London, Kensington And Chelsea, United Kingdom
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Manchester, , United Kingdom
Wirral, , United Kingdom
Córdoba, , Argentina
Nanning, Guangxi, China
Santiago, Región Metropolitana De Santiago, Chile
Liuzhou, Guangxi, China
Fukuyama Shi, Hiroshima, Japan
Bellinzona, , Switzerland
Fukuyama Shi, Hiroshima, Japan
Tucson, Arizona, United States
Saint Petersburg, Florida, United States
West Palm Beach, Florida, United States
Bronx, New York, United States
Hawthorne, New York, United States
Syracuse, New York, United States
Massillon, Ohio, United States
Abilene, Texas, United States
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Itajaí, Santa Catarina, Brazil
Bauru, São Paulo, Brazil
Huai'an, Jiangsu, China
Mexico, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Santiago De Queretaro, Querétaro, Mexico
San Luis Potosí, , Mexico
Albuquerque, New Mexico, United States
Northport, New York, United States
Houston, Texas, United States
Brisbane, Queensland, Australia
Murdoch, Western Australia, Australia
Dublin, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Bucharest, București, Romania
Bellinzona, Ticino, Switzerland
Adana, , Turkey
Adana, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Istanbul, , Turkey
Canton, Ohio, United States
Abilene, Texas, United States
Fortaleza, Ceará, Brazil
Belem, Pará, Brazil
São Caetano Do Sul, São Paulo, Brazil
Herne, Nordrhein Westfalen, Germany
Lisbon, Lisboa, Portugal
Coimbra, , Portugal
Porto, , Portugal
Porto, , Portugal
Riyadh, Ar Riyāḑ, Saudi Arabia
Jeddah, Makkah Al Mukarramah, Saudi Arabia
Münsterlingen, , Switzerland
New York, New York, United States
Vandoeuvre Lès Nancy, Meurthe Et Moselle, France
Bayonne, , France
Dublin, , Ireland
Naples, Napoli, Italy
Ravenna, , Italy
Akashi, , Japan
Tauranga, Bay Of Plenty, New Zealand
Auckland, , New Zealand
Dunedin, , New Zealand
Wellington, , New Zealand
Palma, Illes Balears [Islas Baleares], Spain
Madrid, Madrid, Comunidad De, Spain
Valencia, València, Spain
Istanbul, , Turkey
Abilene, Texas, United States
Edegem, Antwerpen, Belgium
Xinxiang, Henan, China
Xi'an, Shaanxi, China
Taiyuan, Shanxi, China
Neijiang, Sichuan, China
Ulm, Baden Württemberg, Germany
Hannover, Niedersachsen, Germany
Münster, Nordrhein Westfalen, Germany
Chemnitz, Sachsen, Germany
Dammam, Ash Sharqīyah, Saudi Arabia
Barcelona, Catalunya [Cataluña], Spain
Lancaster, Pennsylvania, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Córdoba, , Argentina
Santiago, Región Metropolitana De Santiago, Chile
Medellín, Antioquia, Colombia
Valledupar, Cesar, Colombia
Bogotá, Distrito Capital De Bogotá, Colombia
Bogotá, Distrito Capital De Bogotá, Colombia
Pereira, Risaralda, Colombia
Cali, Valle Del Cauca, Colombia
Mexico, , Mexico
Tauranga, Bay Of Plenty, New Zealand
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Sandton, Gauteng, South Africa
Soweto, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Exeter, Devon, United Kingdom
New Delhi, Delhi, India
Mumbai, Maharashtra, India
Sendai, Miyagi, Japan
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Greenville, North Carolina, United States
Cincinnati, Ohio, United States
Córdoba, , Argentina
Liège, , Belgium
Bauru, São Paulo, Brazil
Viña Del Mar, Valparaíso, Chile
Toulouse, Haute Garonne, France
Secunderabad, Telangana, India
Ravenna, Emilia Romagna, Italy
Yokohama, Kanagawa, Japan
Nankoku, Kochi, Japan
Majadahonda, Madrid, Comunidad De, Spain
Belo Horizonte, Minas Gerais, Brazil
Hwasun, Jeonranamdo, Korea, Republic Of
Seongnam Si, Kyǒnggi Do, Korea, Republic Of
Busan, Pusan Kwangyǒkshi, Korea, Republic Of
Poznań, Wielkopolskie, Poland
Ploiești, , Romania
Johannesburg, Gp, South Africa
Pretoria, Gp, South Africa
Sandton, Gp, South Africa
Soweto, Gp, South Africa
New York, New York, United States
Fortaleza, Ceará, Brazil
Wanzhou, Chongqing, China
Nanchang, Jiangxi, China
Barretos, , Brazil
Abb, , Argentina
Santiago, , Chile
São Caetano Do Sul, , Brazil
Santiago, , Chile
Krems, , Austria
Wels, , Austria
Brussels, , Belgium
Fortaleza, , Brazil
Belem, , Brazil
Bauru, , Brazil
Santiago, , Chile
Bogotá, , Colombia
Bogotá, , Colombia
Montpellier, , France
Toulon, , France
Pierre Bénite, , France
Esslingen, , Germany
Ulm, , Germany
Seongnam Si, , Korea, Republic Of
Busan, , Korea, Republic Of
Santiago De Queretaro, , Mexico
łódź, , Poland
Bucharest, , Romania
Bucharest, , Romania
Riyadh, , Saudi Arabia
Dammam, , Saudi Arabia
A Coruña, , Spain
Barcelona, , Spain
Barcelona, , Spain
L'hospitalet De Llobregat, , Spain
Palma, , Spain
Madrid, , Spain
Madrid, , Spain
Majadahonda, , Spain
Valencia, , Spain
London, , United Kingdom
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported