Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
Sponsor: AstraZeneca
Summary
The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC. Study details include: 1. The study duration will be event-driven, with an estimated duration of approximately 8 years. 2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met. 3. The visit frequency will be every 3 weeks during the treatment period. Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.
Official title: A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
582
Start Date
2024-04-29
Completion Date
2031-08-29
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
Osimertinib
Osimertinib 80 mg administered orally once daily (QD).
Datopotamab Deruxtecan
Datopotamab Deruxtecan 6 mg/kg administered as an intravenous (i.v.) infusion every 3 weeks (q3w).
Locations (167)
Research Site
Fountain Valley, California, United States
Research Site
Los Alamitos, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Monica, California, United States
Research Site
Walnut Creek, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Jacksonville, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Orange City, Florida, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Chicago, Illinois, United States
Research Site
Hinsdale, Illinois, United States
Research Site
North Chicago, Illinois, United States
Research Site
Fort Wayne, Indiana, United States
Research Site
Bethesda, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
Saint Paul, Minnesota, United States
Research Site
Bridgeton, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Brooklyn, New York, United States
Research Site
New York, New York, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Webster, Texas, United States
Research Site
Woodway, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Fort Belvoir, Virginia, United States
Research Site
Midlothian, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Tacoma, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Camperdown, Australia
Research Site
Clayton, Australia
Research Site
Kogarah, Australia
Research Site
South Brisbane, Australia
Research Site
Westmead, Australia
Research Site
Barretos, Brazil
Research Site
Natal, Brazil
Research Site
Porto Alegre, Brazil
Research Site
Salvador, Brazil
Research Site
São Paulo, Brazil
Research Site
Edmonton, Alberta, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Changsha, China
Research Site
Chengdu, China
Research Site
Chengdu, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Chongqing, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
Research Site
Hangzhou, China
Research Site
Hangzhou, China
Research Site
Harbin, China
Research Site
Hefei, China
Research Site
Hefei, China
Research Site
Jinan, China
Research Site
Jinan, China
Research Site
Kunming, China
Research Site
Linhai, China
Research Site
Ningbo, China
Research Site
Shanghai, China
Research Site
Shanghai, China
Research Site
Shenyang, China
Research Site
Wenzhou, China
Research Site
Wuhan, China
Research Site
Wuhan, China
Research Site
Xi'an, China
Research Site
Xuzhou, China
Research Site
Yangzhou, China
Research Site
Zhengzhou, China
Research Site
Zhengzhou, China
Research Site
Angers, France
Research Site
Marseille, France
Research Site
Paris, France
Research Site
Strasbourg, France
Research Site
Berlin, Germany
Research Site
Cologne, Germany
Research Site
Erfurt, Germany
Research Site
Frankfurt, Germany
Research Site
Göttingen, Germany
Research Site
Immenhausen, Germany
Research Site
Kiel, Germany
Research Site
Mainz, Germany
Research Site
München, Germany
Research Site
Hong Kong, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Jordan, Hong Kong
Research Site
Lai Chi Kok, Hong Kong
Research Site
Bangalore, India