Lung Cancer Clinical Trial
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Summary
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.
Full Description
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.
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
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There are 150 Locations for this study
Orange Florida, 32763, United States More Info
Principal Investigator
Hinsdale Illinois, 60521, United States More Info
Principal Investigator
Exeter New Hampshire, 03833, United States More Info
Principal Investigator
Lake Success New York, 11042, United States More Info
Principal Investigator
Renton Washington, 98055, United States More Info
Principal Investigator
Caba Buenos Aires, C1414, Argentina
La Plata Buenos Aires, B1900, Argentina
Pilar Buenos Aires, B1629, Argentina
Buenos Aires , C1431, Argentina
Cordoba , X5000, Argentina
Auchenflower Queensland, 4066, Australia
Hyde Park Queensland, 4812, Australia
South Brisbane Queensland, 4101, Australia
Southport Queensland, 4215, Australia
Rio de Janeiro RJ, 22640, Brazil
Ijuí RS, 98700, Brazil
Sao Paulo SP, 01308, Brazil
Rio Grande Do Sul , 90035, Brazil
Sao Paulo , 01509, Brazil
Plovdiv , 4004, Bulgaria
Russe , 7002, Bulgaria
Sofia , 1303, Bulgaria
Levis Quebec, G6V 3, Canada
Montreal Quebec, H4A 3, Canada
Sherbrooke Quebec, J1H 5, Canada
Santiago Region Metropolitana, 75609, Chile
Hefei Anhui, 23000, China
Fuzhou Fujian, 35001, China
Guangzhou Guangdong, 51000, China
Guangzhou Guangdong, 51008, China
Shenzhen Guangdong, 51800, China
Harbin Heilongjiang, 15008, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43006, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Jinan Shandong, 25011, China
Shenyang Shengyang, 11004, China
Chengdu Sichuan, 61004, China
Hangzhou Zhe Jiang, 31000, China
Hangzhou Zhejiang, 31002, China
Beijing , 10003, China
Beijing , 10073, China
Chongqing , 40004, China
Shanghai , 20002, China
Zhengzhou , 45000, China
Medellin Antioquia, 05000, Colombia
Valledupar Cesar, 56023, Colombia
Monteria , 23000, Colombia
Zagreb , 10000, Croatia
Ostrava Vitkovice , 703 8, Czechia
Aalborg , DK 90, Denmark
Odense C , DK 50, Denmark
Tartu , 50406, Estonia
Turku , FI-20, Finland
Vaasa , 65130, Finland
Athens GR, 115 2, Greece
Athens , 11526, Greece
Heraklion Crete , 711 1, Greece
Thessaloniki , 54622, Greece
Hong Kong , 99907, Hong Kong
Kowloon , , Hong Kong
Shatin New Territories , , Hong Kong
Torokbalint Pest, 2045, Hungary
Budapest , 1121, Hungary
Reykjavik , IS-10, Iceland
Hyderabad Andhra Pradesh, 500 0, India
Visakhapatnam Andhrapradesh, 53001, India
Bangalore Karnataka, 56007, India
Nashik Maharashtra, 422 0, India
Jaipur Rajasthan, 30201, India
Kolkata West Bengal, 70016, India
Delhi , 110 0, India
Mumbai , 400 0, India
Bergamo BG, 24127, Italy
Cremona CR, 26100, Italy
Lucca LU, 55100, Italy
Aviano PN, 33081, Italy
Roma RM, 00128, Italy
Amman , 11941, Jordan
Amman , 1857, Jordan
Irbid , 22110, Jordan
Daegu Dalseo Gu, 42602, Korea, Republic of
Seongnam Si Gyeonggi Do, 13620, Korea, Republic of
Seoul Korea, 08308, Korea, Republic of
Seoul Seocho Gu, 06591, Korea, Republic of
Busan , 49241, Korea, Republic of
Jinju , 660-7, Korea, Republic of
Seoul , 05030, Korea, Republic of
Seoul , 05505, Korea, Republic of
Ashrafieh , 16683, Lebanon
Beirut , 1107 , Lebanon
Dora , 90375, Lebanon
Saida , 652, Lebanon
Kuching Sarawak, 93586, Malaysia
Petaling Jaya Selangor Darul Ehsan, 46150, Malaysia
Petaling Jaya Selangor, 46050, Malaysia
Kuala Lumpur , 59100, Malaysia
Cuautitlan Izcalli Estado De Mexico, 54769, Mexico
Guadalajara Jalisco, 44280, Mexico
Mexico City , 06760, Mexico
Veracruz , 91900, Mexico
Drammen , 3004, Norway
Oslo , NO 04, Norway
Trondheim , 7006, Norway
Rzeszow , 35-05, Poland
Warszawa , 02 78, Poland
Lisboa , 1998-, Portugal
Matosinhos , 4454 , Portugal
Porto , 4100-, Portugal
Alba Iulia Alba, 51007, Romania
Floresti Cluj, 40728, Romania
Craiova Dolj, 20034, Romania
Bucharest , 02232, Romania
Cluj Napoca , 40005, Romania
Cluj-Napoca , 40012, Romania
Constanta , 90590, Romania
Iasi , 70048, Romania
Suceava , 72752, Romania
Timisoara , 30042, Romania
Belgrade , 11000, Serbia
Golnik , 4204, Slovenia
Ljubljana , 1000, Slovenia
Cordoba Andalucia, 14004, Spain
Oviedo Asturias, 33011, Spain
Badalona Catalunya, 08916, Spain
Alicante Comunidad Valenciana, 03010, Spain
La Coruna Galicia, 15006, Spain
Pamplona Navarra, 31008, Spain
Madrid , 28009, Spain
Tainan , 70403, Taiwan
Taipei , 10361, Taiwan
Taoyuan , 33305, Taiwan
Khon Kaen THA, 40002, Thailand
Bangkok , 10110, Thailand
Bangkok , 10330, Thailand
Bangkok , 10700, Thailand
Ankara Yenimahalle, 06200, Turkey
Adana , 01140, Turkey
Ankara , 06100, Turkey
Ankara , 06560, Turkey
Ankara , 06680, Turkey
Antalya , 07059, Turkey
Cankaya Ankara , 06560, Turkey
Fatih / Istanbul , 34093, Turkey
Fatih , 34093, Turkey
Istanbul , 34662, Turkey
Istanbul , 34722, Turkey
Istanbul , 34890, Turkey
Konya , 42080, Turkey
Malatya , 44280, Turkey
Sakarya , 54290, Turkey
Stoke on Trent Staffordshire, ST46Q, United Kingdom
Staffordshire , WS11 , United Kingdom
Hanoi , 30000, Vietnam
Ho Chi Minh , 70000, Vietnam
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