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Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Sponsor: Novartis Pharmaceuticals
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.
Official title: A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
95
Start Date
2022-06-15
Completion Date
2026-03-30
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
JDQ443
JDQ443 tablets, orally administered
docetaxel
docetaxel concentrated solution for infusion, intravenously administered
Locations (53)
Valley Medical Center Research
Renton, Washington, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Pilar, Buenos Aires, Argentina
Novartis Investigative Site
Auchenflower, Queensland, Australia
Novartis Investigative Site
South Brisbane, Queensland, Australia
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Sherbrooke, Quebec, Canada
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Fuzhou, Fujian, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Harbin, Heilongjiang, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Shengyang, Liaoning, China
Novartis Investigative Site
Jinan, Shandong, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Chongqing, China
Novartis Investigative Site
Turku, Finland
Novartis Investigative Site
Athens, GR, Greece
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Heraklion Crete., Greece
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Kowloon, Hong Kong
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Reykjavik, Iceland
Novartis Investigative Site
Jaipur, Rajasthan, India
Novartis Investigative Site
Delhi, India
Novartis Investigative Site
Lucca, LU, Italy
Novartis Investigative Site
Aviano, PN, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Amman, Jordan
Novartis Investigative Site
Ed Daoura, Lebanon
Novartis Investigative Site
Kuching, Sarawak, Malaysia
Novartis Investigative Site
Kuala Lumpur, Malaysia
Novartis Investigative Site
Mexico City, Mexico
Novartis Investigative Site
Matosinhos Municipality, Portugal
Novartis Investigative Site
Porto, Portugal
Novartis Investigative Site
Cluj-Napoca, Cluj, Romania
Novartis Investigative Site
Ljubljana, Slovenia
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Pamplona, Navarre, Spain
Novartis Investigative Site
Oviedo, Principality of Asturias, Spain
Novartis Investigative Site
Córdoba, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Tainan, Taiwan
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Adana, Adana, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Bilkent-Cankaya, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Pendik, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey (Türkiye)
Novartis Investigative Site
Hanoi, Vietnam