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%
NCT Number: NCT06561386
Acronym: RELATIVITY1093
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Non-small Cell Lung Cancer
Interventions: DRUG: Nivolumab|DRUG: Relatlimab|DRUG: Pembrolizumab|DRUG: Carboplatin|DRUG: Pemetrexed|DRUG: Cisplatin
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-20
Completion Date: 2033-11-11
Locations: Local Institution - 0111, Los Angeles, California, 90404, United States|Local Institution - 0112, Los Angeles, California, 90404, United States|Local Institution - 0304, Sacramento, California, 95817, United States|Local Institution - 0159, San Francisco, California, 94115, United States|Local Institution - 0206, Miami, Florida, 33136, United States|Local Institution - 0162, Pembroke Pines, Florida, 33028, United States|Local Institution - 0128, Edgewood, Kentucky, 41017, United States|Local Institution - 0226, Hattiesburg, Mississippi, 39401-7233, United States|Local Institution - 0308, Bozeman, Montana, 59715, United States|Local Institution - 0207, Reno, Nevada, 89502, United States|Local Institution - 0346, Paterson, New Jersey, 07503, United States|Local Institution - 0325, Rochester, New York, 14642, United States|Local Institution - 0199, Cleveland, Ohio, 44106, United States|Local Institution - 0272, Lancaster, Pennsylvania, 17602, United States|Local Institution - 0305, Harlingen, Texas, 78550, United States|Local Institution - 0303, Tyler, Texas, 75701, United States|Local Institution - 0302, Salt Lake City, Utah, 84112, United States|Local Institution - 0217, Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina|Local Institution - 0236, Mar del Plata, Buenos Aires, 7600, Argentina|Local Institution - 0219, ABB, Ciudad Autónoma De Buenos Aires, C1199ABB, Argentina|Local Institution - 0218, Río Cuarto, Córdoba, X5800AEV, Argentina|Local Institution - 0216, Rosario, Santa Fe, S2000DSV, Argentina|Local Institution - 0215, Córdoba, 5016, Argentina|Local Institution - 0058, Gosford, New South Wales, 2250, Australia|Local Institution - 0068, Brisbane, Queensland, 4120, Australia|Local Institution - 0057, Elizabeth Vale, South Australia, 5112, Australia|Local Institution - 0054, Box Hill, Victoria, 3128, Australia|Local Institution - 0056, Murdoch, Western Australia, 6150, Australia|Local Institution - 0314, Krems, Niederösterreich, 3500, Austria|Local Institution - 0292, Wels, Oberösterreich, 4600, Austria|Local Institution - 0294, Feldkirch, 6800, Austria|Local Institution - 0293, Wien, 1210, Austria|Local Institution - 0039, Brussels, Bruxelles-Capitale, Région De, 1090, Belgium|Local Institution - 0187, Hasselt, Limburg, 3500, Belgium|Local Institution - 0038, Yvoir, Namur, 5530, Belgium|Local Institution - 0041, Roeselare, West-Vlaanderen, 8800, Belgium|Local Institution - 0151, Natal, Rio Grande Do Norte, 59075-740, Brazil|Local Institution - 0083, Porto Alegre, Rio Grande Do Sul, 90035-903, Brazil|Local Institution - 0152, Barretos, São Paulo, 14784400, Brazil|Local Institution - 0232, Rio de Janeiro, 20231-050, Brazil|Local Institution - 0147, São Paulo, 01246-000, Brazil|Local Institution - 0249, Santiago, Región Metropolitana De Santiago, 7500921, Chile|Local Institution - 0212, Santiago, Región Metropolitana De Santiago, 8330032, Chile|Local Institution - 0214, Santiago, Región Metropolitana De Santiago, 8420383, Chile|Local Institution - 0182, Hefei, Anhui, 230031, China|Local Institution - 0070, Beijing, Beijing, 100142, China|Local Institution - 0238, Chongqing, Chongqing, 400030, China|Local Institution - 0244, Wanzhou, Chongqing, 404199, China|Local Institution - 0075, Fuzhou, Fujian, 350014, China|Local Institution - 0098, Guangzhou, Guangdong, 0, China|Local Institution - 0307, Guangzhou, Guangdong, 510080, China|Local Institution - 0067, Guangzhou, Guangdong, 510120, China|Local Institution - 0326, Huizhou, Guangdong, 516001, China|Local Institution - 0134, Nanning, Guangxi, 530021, China|Local Institution - 0102, Harbin, Heilongjiang, 150081, China|Local Institution - 0237, Zhengzhou, Henan, 450000, China|Local Institution - 0235, Wuhan, Hubei, 430079, China|Local Institution - 0072, Changsha, Hunan, 410013, China|Local Institution - 0181, Shenyang, Liaoning, 110042, China|Local Institution - 0074, Jinan, Shandong, 250117, China|Local Institution - 0064, Shanghai, Shanghai, 200030, China|Local Institution - 0280, Shanghai, Shanghai, 200030, China|Local Institution - 0318, Shanghai, Shanghai, 200032, China|Local Institution - 0121, Chengdu, Sichuan, 610041, China|Local Institution - 0177, Tianjin, Tianjin, 300060, China|Local Institution - 0071, Hangzhou, Zhejiang, 310003, China|Local Institution - 0099, Hangzhou, Zhejiang, 310016, China|Local Institution - 0338, Hangzhou, Zhejiang, 310022, China|Local Institution - 0101, Linhai, Zhejiang, 317000, China|Local Institution - 0198, Aarhus, Midtjylland, 8200, Denmark|Local Institution - 0124, Soenderborg, Syddanmark, 6400, Denmark|Local Institution - 0125, Copenhagen, 2100, Denmark|Local Institution - 0092, Montpellier, Hérault, 34298, France|Local Institution - 0093, Rennes, Ille-et-Vilaine, 35033, France|Local Institution - 0096, Lille, Nord-Pas-de-Calais, 59037, France|Local Institution - 0091, Toulon, Provence-Alpes-Côte-d'Azur, 83100, France|Local Institution - 0157, Pierre-Bénite, Rhône, 69310, France|Local Institution - 0158, Marseille, 13915, France|Local Institution - 0089, Paris, 75014, France|Local Institution - 0095, Paris, 75248, France|Local Institution - 0284, Esslingen, Baden-Württemberg, 73730, Germany|Local Institution - 0287, Kempten, Bayern, 87439, Germany|Local Institution - 0347, München, Bayern, 81377, Germany|Local Institution - 0281, Frankfurt, Hessen, 60488, Germany|Local Institution - 0313, Marburg, Hessen, 35033, Germany|Local Institution - 0316, Grosshansdorf, Schleswig-Holstein, 22927, Germany|Local Institution - 0283, Bad Berka, Thüringen, 99437, Germany|Local Institution - 0285, Berlin, 13353, Germany|Local Institution - 0282, Bonn, 53127, Germany|Local Institution - 0288, Essen, 45122, Germany|Local Institution - 0286, Gauting, 82131, Germany|Local Institution - 0317, Heidelberg, 69126, Germany|Local Institution - 0329, New Delhi, Delhi, 110029, India|Local Institution - 0337, New Delhi, Delhi, 110085, India|Local Institution - 0333, Bengaluru, Karnataka, 560017, India|Local Institution - 0331, Thiruvananthapuram, Kerala, 695011, India|Local Institution - 0336, Mumbai, Maharashtra, 400012, India|Local Institution - 0328, Howrah, West Bengal, 711103, India|Local Institution - 0045, Monza, Lombardia, 20900, Italy|Local Institution - 0046, Naples, Napoli, 80131, Italy|Local Institution - 0043, Bari, Puglia, 70124, Italy|Local Institution - 0250, Rome, Roma, 00144, Italy|Local Institution - 0221, Peschiera del Garda, Verona, 37019, Italy|Local Institution - 0312, Kashiwa, Chiba, 277-8577, Japan|Local Institution - 0320, Kitakyushu, Fukuoka, 807-8556, Japan|Local Institution - 0273, Kurume, Fukuoka, 830-0011, Japan|Local Institution - 0276, Fukuyama, Hiroshima, 720-0001, Japan|Local Institution - 0311, Sapporo, Hokkaido, 003-0804, Japan|Local Institution - 0321, Yokohama, Kanagawa, 2418515, Japan|Local Institution - 0339, Sendai, Miyagi, 9810914, Japan|Local Institution - 0322, Kashihara, Nara, 634-0813, Japan|Local Institution - 0279, Niigata-shi, Niigata, 951-8566, Japan|Local Institution - 0306, Kurashiki, Okayama, 710-8602, Japan|Local Institution - 0275, Hirakata, Osaka, 573-1191, Japan|Local Institution - 0277, Osaka-sayama, Osaka, 589-8511, Japan|Local Institution - 0274, Hidaka, Saitama, 350-1298, Japan|Local Institution - 0278, Hamamatsu, Shizuoka, 431-3192, Japan|Local Institution - 0310, Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan|Local Institution - 0323, Koto, Tokyo, 135-8550, Japan|Local Institution - 0327, Akashi, 6738558, Japan|Local Institution - 0319, Fukushima, 960-1295, Japan|Local Institution - 0340, Osaka, 541-8567, Japan|Local Institution - 0220, Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, Korea, Republic of|Local Institution - 0234, Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565, Korea, Republic of|Local Institution - 0201, Goyang-si, Kyǒnggi-do, 10408, Korea, Republic of|Local Institution - 0175, Seoul, Seoul-teukbyeolsi [Seoul], 03722, Korea, Republic of|Local Institution - 0233, Seoul, Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of|Local Institution - 0176, Seoul, Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of|Local Institution - 0030, Harderwijk, Gelderland, 3844 DG, Netherlands|Local Institution - 0193, Heerlen, Limburg, 6419 PC, Netherlands|Local Institution - 0196, Den Bosch, Noord-Brabant, 5223 GZ, Netherlands|Local Institution - 0195, Zwolle, Overijssel, 8025 AB, Netherlands|Local Institution - 0036, Leiden, Zuid-Holland, 2333 ZA, Netherlands|Local Institution - 0315, The Hague, Zuid-Holland, 2512 VA, Netherlands|Local Institution - 0033, Arnhem, 6815 AD, Netherlands|Local Institution - 0032, Groningen, 9700 RB, Netherlands|Local Institution - 0259, Warsaw, Mazowieckie, 04-125, Poland|Local Institution - 0258, Prabuty, Pomorskie, 82-550, Poland|Local Institution - 0255, Konin, Wielkopolskie, 62-500, Poland|Local Institution - 0261, Poznan, Wielkopolskie, 60-693, Poland|Local Institution - 0256, Skorzewo, Wielkopolskie, 60-185, Poland|Local Institution - 0257, Koszalin, Zachodniopomorskie, 75-581, Poland|Local Institution - 0260, Bydgoszcz, 85796, Poland|Local Institution - 0254, Łódź, Łódzkie, 93-338, Poland|Local Institution - 0296, Bucharest, Bucuresti, 013812, Romania|Local Institution - 0298, Bucharest, București, 022338, Romania|Local Institution - 0299, Florești, Cluj, 407280, Romania|Local Institution - 0295, Craiova, Dolj, 200542, Romania|Local Institution - 0297, Ploiești, Prahova, 100337, Romania|Local Institution - 0301, Cluj, 400015, Romania|Local Institution - 0300, Iași, 700483, Romania|Local Institution - 0270, A Coruña, A Coruña [La Coruña], 15006, Spain|Local Institution - 0264, Barcelona, Barcelona [Barcelona], 08035, Spain|Local Institution - 0267, L'Hospitalet de Llobregat, Catalunya [Cataluña], 08908, Spain|Local Institution - 0265, Madrid, Madrid, Comunidad De, 28041, Spain|Local Institution - 0266, Málaga, 29011, Spain|Local Institution - 0268, Sevilla, 41013, Spain|Local Institution - 0269, València, 46026, Spain|Local Institution - 0289, st.Gallen, Sankt Gallen, 9007, Switzerland|Local Institution - 0291, Lausanne, Vaud, 1011, Switzerland|Local Institution - 0290, Basel, 4031, Switzerland|Local Institution - 0118, New Taipei, 235, Taiwan|Local Institution - 0117, Taichung, 407, Taiwan|Local Institution - 0116, Taipei, 10002, Taiwan|Local Institution - 0119, Taipei, 11217, Taiwan|Local Institution - 0271, Larbert, Falkirk, FK5 4WR, United Kingdom|Local Institution - 0189, Glasgow, Glasgow City, g12OYN, United Kingdom|Local Institution - 0021, London, Kensington And Chelsea, SW3 6JJ, United Kingdom|Local Institution - 0348, London, London, City Of, EC1A 7BE, United Kingdom|Local Institution - 0001, London, London, City Of, SE1 9RT, United Kingdom|Local Institution - 0020, Manchester, M20 4BX, United Kingdom|Local Institution - 0024, Wirral, CH63 4JY, United Kingdom

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%

Primary Outcome Measures: Overall survival (OS), Up to 5 years
Secondary Outcome Measures: Progression-free survival (PFS), Up to 5 years|Overall response rate (ORR), Up to 5 years|Duration of response (DoR), Up to 5 years|Number of participants with adverse events (AEs), Up to 2.5 years|Number of participants with serious adverse events (SAEs), Up to 2.5 years|Number of participants with immune-mediated adverse events (IMAEs), 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