Study Description
This is a phase III randomized open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.
The study has been designed as a Phase III trial and consists of 2 parts:
Randomized part will evaluate the efficacy and safety of JDQ443 as monotherapy in comparison with docetaxel. Participants randomized to docetaxel arm will have the opportunity to cross-over to JDQ443 at disease progression per RECIST 1.1 confirmed by BIRC.
Extension part will be open after final progression-free survival (PFS) analysis (if the primary endpoint has met statistical significance) to allow participants randomized to docetaxel treatment to crossover to receive JDQ443 treatment regardless of progression on docetaxel.
The study population will include adult participants with locally advanced or metastatic (stage IIIB/IIIC or IV) KRAS G12C mutant non-small cell lung cancer (by tissue or plasma as determined by a Novartis-designated central laboratory or accepted local tests) who have received prior platinum-based chemotherapy and prior immune checkpoint inhibitor therapy administered either in sequence or as combination therapy.
Approximately 360 participants will be randomized to JDQ443 or docetaxel in a 1:1 ratio stratified by prior line of therapy and ECOG performance status.
Interventions
docetaxel
JDQ443
Eligibility Criteria
Inclusion Criteria:
Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests.
Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.
Exclusion Criteria:
Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other KRAS G12C inhibitor.
Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines.
Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Participant has an history of interstitial lung disease or pneumonitis grade > 1.
Other inclusion/exclusion criteria may apply
Study Location
Novartis Investigative Site
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Cordoba,X5000JHQ,Argentina
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La Plata,Buenos Aires,B1900AWT,Argentina
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Buenos Aires,C1431FWO,Argentina
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Pilar,Buenos Aires,B1629AHJ,Argentina
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Caba,Buenos Aires,C1414DRK,Argentina
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South Brisbane,Queensland,4101,Australia
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Auchenflower,Queensland,4066,Australia
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Southport,Queensland,4215,Australia
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Hyde Park,Queensland,4812,Australia
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Rio de Janeiro,RJ,22640-000,Brazil
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Rio Grande Do Sul,90035-001,Brazil
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Ijuí,RS,98700-000,Brazil
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Sao Paulo,01509-010,Brazil
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Sao Paulo,SP,01308-050,Brazil
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Sofia,1303,Bulgaria
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Russe,7002,Bulgaria
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Plovdiv,4004,Bulgaria
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Sherbrooke,Quebec,J1H 5N4,Canada
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Levis,Quebec,G6V 3Z1,Canada
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Montreal,Quebec,H4A 3J1,Canada
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Santiago,Region Metropolitana,7560908,Chile
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Changsha,Hunan,410013,China
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Harbin,Heilongjiang,150081,China
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Jinan,Shandong,250117,China
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Guangzhou,Guangdong,51000,China
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Chengdu,Sichuan,610041,China
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Wuhan,Hubei,430022,China
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Hefei,Anhui,230001,China
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Nanjing,Jiangsu,210008,China
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Guangzhou,Guangdong,510080,China
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Chongqing,400042,China
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Wuhan,Hubei,430060,China
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Beijing,100036,China
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Hangzhou,Zhe Jiang,310003,China
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Hangzhou,Zhejiang,310022,China
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Beijing,100730,China
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Shanghai,200025,China
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Fuzhou,Fujian,350014,China
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Zhengzhou,450008,China
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Shenzhen,Guangdong,518000,China
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Medellin,Antioquia,050001,Colombia
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Valledupar,Cesar,5602310,Colombia
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Monteria,230004,Colombia
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Zagreb,10000,Croatia
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Ostrava Vitkovice,703 84,Czech Republic
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Odense C,DK 5000,Denmark
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Tartu,50406,Estonia
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Turku,FI-20521,Finland
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Vaasa,65130,Finland
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Athens,11526,Greece
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Athens,GR,115 27,Greece
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Heraklion Crete,711 10,Greece
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Thessaloniki,54622,Greece
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Hong Kong,999077,Hong Kong
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Shatin New Territories,Hong Kong
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Budapest,1121,Hungary
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Torokbalint,Pest,2045,Hungary
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Reykjavik,IS-101,Iceland
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Bangalore,Karnataka,560076,India
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Hyderabad,Andhra Pradesh,500 034,India
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Mumbai,400 012,India
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Nashik,Maharashtra,422 004,India
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Kolkata,West Bengal,700160,India
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Delhi,110 085,India
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Visakhapatnam,Andhrapradesh,530017,India
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Jaipur,Rajasthan,302019,India
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Lucca,LU,55100,Italy
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Roma,RM,00128,Italy
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Aviano,PN,33081,Italy
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Amman,1857,Jordan
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Irbid,22110,Jordan
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Amman,11941,Jordan
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Seoul,05030,Korea, Republic of
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Seoul,05505,Korea, Republic of
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Jinju,660-702,Korea, Republic of
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Seoul,Korea,08308,Korea, Republic of
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Seoul,Seocho Gu,06591,Korea, Republic of
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Busan,49241,Korea, Republic of
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Daegu,Dalseo Gu,42602,Korea, Republic of
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Seongnam Si,Gyeonggi Do,13620,Korea, Republic of
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Ashrafieh,166830,Lebanon
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Beirut,1107 2020,Lebanon
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Saida,652,Lebanon
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Dora,90375,Lebanon
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Kuching,Sarawak,93586,Malaysia
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Petaling Jaya,Selangor Darul Ehsan,46150,Malaysia
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Petaling Jaya,Selangor,46050,Malaysia
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Kuala Lumpur,59100,Malaysia
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Guadalajara,Jalisco,44280,Mexico
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Cuautitlan Izcalli,Estado De Mexico,54769,Mexico
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Mexico City,06760,Mexico
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Veracruz,91900,Mexico
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Drammen,3004,Norway
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Trondheim,7006,Norway
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Warszawa,02 781,Poland
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Rzeszow,35-055,Poland
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Matosinhos,4454 513,Portugal
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Lisboa,1998-018,Portugal
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Porto,4100-180,Portugal
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Bucharest,022328,Romania
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Iasi,700483,Romania
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Craiova,Dolj,200347,Romania
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Cluj Napoca,400058,Romania
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Floresti,Cluj,407280,Romania
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Cluj-Napoca,400124,Romania
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Alba Iulia,Alba,510077,Romania
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Constanta,905900,Romania
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Timisoara,300425,Romania
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Belgrade,11000,Serbia
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Golnik,4204,Slovenia
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Ljubljana,1000,Slovenia
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Pamplona,Navarra,31008,Spain
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Madrid,28009,Spain
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La Coruna,Galicia,15006,Spain
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Alicante,Comunidad Valenciana,03010,Spain
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Badalona,Catalunya,08916,Spain
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Oviedo,Asturias,33011,Spain
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Cordoba,Andalucia,14004,Spain
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Tainan,70403,Taiwan
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Taipei,103616,Taiwan
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Taoyuan,33305,Taiwan
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Bangkok,10330,Thailand
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Bangkok,10700,Thailand
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Khon Kaen,THA,40002,Thailand
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Sakarya,54290,Turkey
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Fatih,34093,Turkey
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Ankara,06100,Turkey
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Cankaya Ankara,06560,Turkey
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Adana,01140,Turkey
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Ankara,06680,Turkey
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Istanbul,34662,Turkey
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Ankara,Yenimahalle,06200,Turkey
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Istanbul,34890,Turkey
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Antalya,07059,Turkey
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Staffordshire,WS11 5XY,United Kingdom
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Stoke on Trent,Staffordshire,ST46QG,United Kingdom
Exeter Hospital
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Exeter,Julie Bushey email: [email protected] -- Panos Fidias,03833 - New Hampshire,United States
Hope And Healing Care Research
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Hinsdale,Praneetha Achanta email: [email protected] -- Srilata Gundala,60521 - Illinois,United States
Mid Florida Hematology And Onc Ctr
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Orange,Amanda Wise (386-774-1223) email: [email protected] -- Santosh Nair,32763 - Florida,United States
Valley Medical Center Research Valley Professional Center Bld
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Renton,Melissa Bennett email: [email protected] -- Navanshu Arora,98055 - Washington,United States
Clinical Research Alliance Research
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Lake Success,Krishna Pandit (+1 516 488 2918#183) email: [email protected] -- James D Olimpio,11042 - New York,United States
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Ho Chi Minh,700000,Vietnam
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Hanoi,300000,Vietnam
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