A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
- Trial number:
- NCT05920356
- Trial phase:
- 3
- Study type:
- Chemotherapy, Targeted therapy
- Overall status:
- Not yet recruiting
Study start date
November, 2023
Scientific title
A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)
Summary
The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testingNo history of systemic anticancer therapy in metastatic/non-curable settings Eastern Cooperative Oncology Group (ECOG) ≤ 1
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Masking:
None (Open Label),
Conditions
Non-Small Cell Lung Cancer (NSCLC)
Other study ID numbers
20190341; 2022-501863-41
Choose trial site (202)
Tan Tock Seng Hospital Singapore
University of New Mexico Cancer Center
1201 Camino de Salud NE, Albuquerque, NM 87102, USA
Duke University Medical Center
Durham, NC 27710, USA
University of Tennessee Medical Center Knoxville
Knoxville, TN 37996, USA
GenesisCare -North Shore Oncology
North Shore Health Hub, Tower A, Level 1/7 Westbourne St, St Leonards NSW 2065, Australia
Toowoomba Hospital
Private Mail Bag 2, Pechey St, Toowoomba City QLD 4350, Australia
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102, Australia
Cancer Research South Australia
337 South Tce, Adelaide SA 5000, Australia
Peter MacCallum Cancer Centre
305 Grattan St, Melbourne VIC 3052, Australia
The Alfred Hospital
55 Commercial Rd, Melbourne VIC 3004, Australia
Universitaetsklinikum Krems
Mitterweg 10, 3500 Krems an der Donau, Austria
Landeskrankenhaus Salzburg
Müllner Hauptstraße 48, 5020 Salzburg, Austria
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
ul. "Georgi Benkovski" 100, 4500 Panagyurishte, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Клиника по гастроентерология, Sofia Center, ul. "Byalo more" №8, 1527 Sofia, Bulgaria
Clinica CIDO
4810218 Temuco, Araucania, Chile
Fundacion Arturo Lopez Perez
José Manuel Infante 805, 7500921 Providencia, Región Metropolitana, Chile
Aarhus Universitetshospital
Palle Juul-Jensens Blvd. 99, 8200 Aarhus, Denmark
Regionshospitalet Godstrup
Hospitalsparken 15, 7400 Herning, Denmark
Rigshospitalet
Blegdamsvej 9, 2100 København, Denmark
Sonderborg Sygehus
Sydvang 1, 6400 Sønderborg, Denmark
Centre Hospitalier Intercommunal de Créteil
40 Av. de Verdun, 94000 Créteil, France
Centre Hospitalier de Cornouaille
14 Av. Yves Thépot, 29000 Quimper, France
Klinikverbund Allgaeu
Robert-Weixler-Straße 50, 87439 Kempten (Allgäu), Germany
Henry Dunant Hospital Center
Leof. Mesogeion 107, Athina 115 26, Greece
Alexandra Hospital
Lourou 4-2, Athina 115 28, Greece
Metropolitan Hospital
Ethnarchou Makariou 9, Pireas 185 47, Greece
Iaso General Clinic
Iaso, Chomatianou 37, Marousi 151 23, Greece
Agios Loukas Clinic
Panorama 552 36, Greece
European Interbalkan Medical Center
Asklipiou 10, Pilea 555 35, Greece
Orszagos Koranyi Pulmonologiai Intezet
Budapest, Korányi Frigyes út 1, 1122 Hungary
Farkasgyepui Tudogyogyintezet
Farkasgyepű, Tüdőgyógyintézet, 8582 Hungary
Matrai Gyogyintezet
Gyöngyös, 3200 Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, Dózsa György út 77, 2800 Hungary
Torokbalinti Tudogyogyintezet
Törökbálint, Munkácsy Mihály u. 70, 2045 Hungary
Azienda Ospedaliera Universitaria Careggi
Largo Piero Palagi, 1, 50139 Firenze FI, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Via Piero Maroncelli, 40, 47014 Meldola FC, Italy
Fondazione IRCCS San Gerardo dei Tintori
Via G. B. Pergolesi, 33, 20900 Monza MB, Italy
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
Via Leonardo Bianchi, 80131 Napoli NA, Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, Province of Perugia, Italy
Nagoya University Hospital
Japan, 〒466-8560 愛知県名古屋市昭和区鶴舞町６５
Hirosaki University Hospital
53 Honchō, Hirosaki, Aomori 036-8563, Japan
Chiba Cancer Center
666-2 Nitonachō, Chuo Ward, Chiba, 260-0801, Japan
National Cancer Center Hospital East
Japan, 〒277-8577 Chiba, Kashiwa, Kashiwanoha, 6-chōme−５−１
National Hospital Organization Shikoku Cancer Center
甲１６０ Minamiumemotomachi, Matsuyama, Ehime 791-0245, Japan
National Hospital Organization Kyushu Cancer Center
811-1395, Japan
Hospital of the University of Occupational and Environmental Health Japan
1-1-1 Iseigaoka, Yahatanishi Ward, Kitakyushu, Fukuoka 807-8556, Japan
Kurume University Hospital
67 Asahimachi, Kurume, Fukuoka 830-0011, Japan
Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers
Fukuyama, Hiroshima, Japan
National Hospital Organization Hokkaido Cancer Center
2-chōme-3-54 Kikusui 4 Jō, Shiroishi Ward, Sapporo, Hokkaido 003-0804, Japan
Kobe Minimally invasive Cancer Center
650-0046, Japan
Takarazuka City Hospital
4-chōme-5-1 Kohama, Takarazuka, Hyogo 665-0827, Japan
Kanazawa University Hospital
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
Miyagi Cancer Center
Nodayama-47-1 Medeshimashiote, Natori, Miyagi 981-1239, Japan
Okayama University Hospital
2-chōme-5-1 Shikatachō, Kita Ward, Okayama, 700-8558, Japan
Kansai Medical University Hospital
2-chōme-3-1 Shinmachi, Hirakata, Osaka 573-1191, Japan
Osaka International Cancer Institute
3-chōme-1-69 Ōtemae, Chuo Ward, Osaka, 540-0008, Japan
National Hospital Organization Kinki-chuo Chest Medical Center
1180 Nagasonechō, Kita Ward, Sakai, Osaka 591-8025, Japan
Shizuoka Cancer Center
1007 Shimonagakubo, Nagaizumi, Sunto District, Shizuoka 411-8777, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
3-chōme-8-31 Ariake, Koto City, Tokyo 135-0063, Japan
Tottori University Hospital
３６番地１ Nishichō, Yonago, Tottori 683-8504, Japan
Wakayama Medical University Hospital
811番地１ Kimiidera, Wakayama, 641-0012, Japan
National Hospital Organization Yamaguchi-Ube Medical Center
685 Higashikiwa, Ube, Yamaguchi 755-0241, Japan
National Cancer Center
323 Ilsan-ro, Goyang-si, Gyeonggi-do, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Korea University Anam Hospital
South Korea, Seoul, Seongbuk-gu, 고려대로 73
Asan Medical Center
88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
Samsung Medical Center
81 Irwon-ro, Gangnam-gu, Seoul, South Korea
Pauls Stradins Clinical University Hospital
Pilsoņu iela 13, Zemgales priekšpilsēta, Rīga, LV-1002, Latvia
Riga East Clinical University Hospital
Hipokrāta iela 2, Vidzemes priekšpilsēta, Rīga, LV-1038, Latvia
Meander Medisch Centrum
Maatweg 3, 3813 TZ Amersfoort, Netherlands
Sint Jansdal Ziekenhuis
Wethouder Jansenlaan 90, 3844 DG Harderwijk, Netherlands
Elisabeth-TweeSteden Ziekenhuis
Hilvarenbeekse Weg 60, 5022 GC Tilburg, Netherlands
Centrum Pulmunologii i Torakochirurgii w Bystrej
Juliana Fałata 2, 43-360 Bystra, Poland
Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
Osiedle Złotej Jesieni 1, 31-826 Kraków, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Doktora Kazimierza Jaczewskiego 8, 20-954 Lublin, Poland
Med Polonia Sp zoo
Obornicka 262, 60-693 Poznań, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Monte Cassino 18, 37-700 Przemyśl, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Wilhelma Konrada Roentgena 5, 02-781 Warszawa, Poland
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, Romania
Centrul de Oncologie Sf Nectarie SRL
Strada Caracal 109, Craiova, Romania
Institutul Regional de Oncologie Iasi
Strada General Henri Mathias Berthelot 2-4, Iași 700483, Romania
SC Oncomed SRL
Timișoara, Romania
Hospital Universitario Virgen del Rocio
Av. Manuel Siurot, S/n, 41013 Sevilla, Spain
Hospital del Mar
Pg. Marítim de la Barceloneta, 25, 29, Ciutat Vella, 08003 Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
C. de Villarroel, 170, L'Eixample, 08036 Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
C/ de Sant Quintí, 89, Horta-Guinardó, 08025 Barcelona, Spain
Hospital Universitario La Paz
P.º de la Castellana, 261, Fuencarral-El Pardo, 28046 Madrid, Spain
Gavle Sjukhus
Gävle, Sweden
Kantonsspital Aarau
Kantonsspital Aarau, 5000 Aarau, Switzerland
Kantonsspital Baden
Im Ergel 1, 5404 Baden, Switzerland
Universitaetsspital Basel
Universitätsspital CH, Petersgraben 4, 4031 Basel, Switzerland
National Cheng Kung University Hospital
Tainan City, Taiwan
National Taiwan University Hospital
No. 7號, Zhongshan S Rd, Zhongzheng District, Taipei City, Taiwan 100
Ankara Bilkent Sehir Hastanesi
Üniversiteler, 06800 Çankaya/Ankara, Türkiye
Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli, Kumkısık, Denizli, Türkiye
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Cerrahpaşa, İstanbul Üniversiesi Cerrahpaşa Tıp Fakültesi, Koca Mustafapaşa Cd. No:53, 34098 Fatih/İstanbul, Türkiye
Bagcilar Medipol Mega Universite Hastanesi
TEM Avrupa otoyolu göztepe çıkışı no:1, Göztepe, 34214 Bağcılar/İstanbul, Türkiye
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Eğitim, Göztepe Araştırma Hst., 34722 Kadıköy/İstanbul, Türkiye
Izmir Ekonomi Universitesi Medical Point Hastanesi
Yeni Girne Bulvarı, İmbatlı, 1825. Sk. No:12, 35575 Karşıyaka/İzmir, Türkiye
Hospital Britanico de Buenos Aires
Perdriel 74, C1280 AEB, Buenos Aires, Argentina
Fundacion Ars Medica
Cnel. Puch 497, Y4600 San Salvador de Jujuy, Jujuy, Argentina
Nova Scotia Health Authority, Queen Elizabeth II, Health Sciences Centre
1276 South Park St, Halifax, NS B3H 2Y9, Canada
Orlandi Oncologia
Gral. Salvo 159, 7500713 Providencia, Región Metropolitana, Chile
Centre Hospitalier Universitaire Ambroise Pare
92100 Boulogne-Billancourt, France
Centre de Cancerologie du Grand Montpellier-Clinique Clementville
25 Rue de Clementville, 34070 Montpellier, France
Hôpital Tenon
4 Rue de la Chine, 75020 Paris, France
Centre Hospitalier Universitaire de Reims - Hôpital Maison blanche
45 Rue Cognacq-Jay, 51100 Reims, France
Theagenion Cancer Hospital
Thessaloniki, Greece
St Marianna University Hospital
2-chōme-16-1 Sugao, Miyamae Ward, Kawasaki, Kanagawa 216-8511, Japan
Kindai University Hospital
377-2 Ōnohigashi, Osakasayama, Osaka 589-8511, Japan
Maastricht Universitair Medisch Centrum
P. Debyelaan 25, 6229 HX Maastricht, Netherlands
Spitalul Municipal Ploiesti
Spitalul Municipal Ploiești, Ploiești, Romania
University of Illinois at Chicago
840 S Wood St, Chicago, IL 60612, USA
University of Pittsburgh Medical Center Hillman Cancer Center
5115 Centre Ave, Pittsburgh, PA 15232, USA
Instituto Argentino de Diagnostico y Tratamiento IADT
Larrea 977, C1122 Cdad. Autónoma de Buenos Aires, Argentina
Clinica Viedma
Sarmiento 253, R8500 Viedma, Río Negro, Argentina
Centro Oncologico Korben
Vidt 1923, C1425 CABA, Argentina
Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
Dorrego 269, F5300 La Rioja, Argentina
Centro de Diagnostico Investigacion y Tratamiento
A4400 Salta, Salta Province, Argentina
Klinikum Klagenfurt am Woerthersee
Feschnigstraße 11, 9020 Klagenfurt am Wörthersee, Austria
Chirec - Delta Ziekenhuis
Bd du Triomphe 201, 1160 Auderghem, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Herestraat 49, 3000 Leuven, Belgium
Centre Hospitalier Regional de la Citadelle
Boulevard du Douzième de Ligne 1, 4000 Liège, Belgium
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Faculdade de Engenharia da Pontifícia Universidade Católica do Rio Grande do Sul - Av. Ipiranga, 6690 - Jardim Botânico, Porto Alegre - RS, 90619-900, Brazil
Biocinetic
8330336 Santiago, Santiago Metropolitan Region, Chile
Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
3 Bd Alexandre Fleming, 25000 Besançon, France
Centre Hospitalier - Le Mans
194 Av. Rubillard, 72037 Le Mans Cedex 9, France
Centre Hospitalier Universitaire Nord
Marseille, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Av. du Haut Lévêque, Pessac, France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
2 Rue de la Milétrie, 86000 Poitiers, France
Hopital d instruction des armees sainte anne
2 Bd Sainte-Anne BP600, 83000 Toulon, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
2 Rue Charles Viguerie, 31300 Toulouse, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
2 Bd Tonnellé, 37000 Tours, France
Hopital Nord-Ouest Villefranche
Plateau d'Ouilly, All. d'ouilly, 69400 Gleize, France
Klinikum Chemnitz GmbH
Flemmingstraße 2, 09116 Chemnitz, Germany
Universitaetsmedizin Goettingen
Robert-Koch-Straße 40, 37075 Göttingen, Germany
251 General Airforce Hospital
Leof. Panagioti Kanellopoulou 3, Athina 115 25, Greece
Attikon University Hospital
Rimini 1, Chaidari 124 62, Greece
University of Hong Kong, Queen Mary Hospital
Pok Fu Lam, Hong Kong
IRCCS Istituto Tumori Giovanni Paolo II
Viale Orazio Flacco, 65, 70124 Bari BA, Italy
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
2-chōme-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa 241-8515, Japan
Sendai Kousei Hospital
Japan, 〒980-0873 Miyagi, Sendai, Aoba Ward, Hirosemachi, 4−１５ 2階
Niigata Cancer Center Hospital
2-chōme-15-3 Kawagishichō, Chūō-ku, Niigata, 951-8133, Japan
Saitama Cancer Center
７８０番地 Komuro, Ina, Kitaadachi District, Saitama 362-0806, Japan
Juntendo University Hospital
3-chōme-1-3 Hongō, Bunkyo City, Tokyo 113-0033, Japan
Universitair Medisch Centrum Groningen
Hanzeplein 1, 9713 GZ Groningen, Netherlands
Isala Klinieken
Dokter van Heesweg 2, 8025 AB Zwolle, Netherlands
Centrum Pulmonologii i Torakochirurgii w Bystrej
Juliana Fałata 2, 43-360 Bystra, Poland
Hospital da Luz, SA
Av. Lusíada 100, 1500-650 Lisboa, Portugal
Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
Alameda das Linhas de Torres, 117 1769-001 Lisboa, 1600 Lisboa, Portugal
Hospital Cuf porto
Estr. da Circunvalação 14341, 4100-180 Porto, Portugal
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest, Romania
Spitalul Universitar de Urgenta Bucuresti
Splaiul Independenței 169, București 050098, Romania
Hospital Universitario Marques de Valdecilla
Av. de Valdecilla, 25, 39008 Santander, Cantabria, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
Avinguda de la Granvia de l’Hospitalet, 199, 08908 L'Hospitalet de Llobregat, Barcelona, Spain
Sahlgrenska Universitetssjukhuset
Blå stråket 5, 413 45 Göteborg, Sweden
Maharaj Nakorn Chiang Mai Hospital
110 ถนนอินทวโรรส ซอย 2 Si Phum, Amphoe Mueang Chiang Mai, Chang Wat Chiang Mai 50200, Thailand