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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony histologicznie lub cytologicznie rak płuca bez drobnych komórek (adenokarcinoma)
- •Zaawansowany lub przerzutowy rak płuca (stadium IIIB-IV) lub nawracający rak, który nie może być operowany
- •Brak wcześniejszego leczenia dla stadium IIIB, IIIC lub IV rakiem płuca
- •Nowotwór ma mutację EGFR (Ex19del lub L858R) potwierdzoną badaniem laboratoryjnym
- •Ogólny stan zdrowia oceniony na 0 lub 1 (pacjent może prowadzić normalne codzienne czynności)
- •Co najmniej jeden guz, który można mierzyć i ma co najmniej 10 mm średnicy
- •Prawidłowe funkcjonowanie szpiku kostnego i narządów wewnętrznych
✗ Disqualifies
- •Poważne lub niekontrolowane choroby uniemożliwiające bezpieczne uczestnictwo w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 26, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (167)
Research Site
Fountain Valley, United States
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Los Alamitos, United States
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Los Angeles, United States
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Los Angeles, United States
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Orange, United States
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San Diego, United States
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Santa Monica, United States
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Walnut Creek, United States
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New Haven, United States
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Washington D.C., United States
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Jacksonville, United States
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Ocala, United States
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Orange City, United States
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Honolulu, United States
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Chicago, United States
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Hinsdale, United States
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North Chicago, United States
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Fort Wayne, United States
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Bethesda, United States
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Detroit, United States
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Saint Paul, United States
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Bridgeton, United States
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St Louis, United States
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Las Vegas, United States
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Brooklyn, United States
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New York, United States
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Dallas, United States
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Houston, United States
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Houston, United States
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Webster, United States
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Woodway, United States
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Fairfax, United States
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Fort Belvoir, United States
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Midlothian, United States
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Seattle, United States
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Tacoma, United States
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Milwaukee, United States
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Camperdown, Australia
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Clayton, Australia
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Kogarah, Australia
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South Brisbane, Australia
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Westmead, Australia
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Barretos, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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Edmonton, Canada
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Montreal, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chengdu, China
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Chengdu, China
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Chongqing, China
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Chongqing, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Harbin, China
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Hefei, China
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Hefei, China
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Jinan, China
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Jinan, China
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Kunming, China
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Linhai, China
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Ningbo, China
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Shanghai, China
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Shanghai, China
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Shenyang, China
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Wenzhou, China
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Wuhan, China
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Wuhan, China
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Xi'an, China
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Xuzhou, China
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Yangzhou, China
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Zhengzhou, China
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Zhengzhou, China
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Angers, France
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Marseille, France
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Paris, France
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Strasbourg, France
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Berlin, Germany
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Cologne, Germany
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Erfurt, Germany
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Frankfurt, Germany
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Göttingen, Germany
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Immenhausen, Germany
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Kiel, Germany
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Mainz, Germany
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München, Germany
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Jordan, Hong Kong
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Lai Chi Kok, Hong Kong
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Bangalore, India
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Delhi, India
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Hyderabad, India
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Kolkata, India
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Mysuru, India
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Nagpur, India
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Nashik, India
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New Delhi, India
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New Delhi, India
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Vadodara, India
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Varanasi, India
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Milan, Italy
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Monza, Italy
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Orbassano, Italy
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Padova, Italy
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Parma, Italy
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Chūōku, Japan
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Fukuoka, Japan
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Kashiwa, Japan
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Kōtoku, Japan
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Niigata, Japan
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Osaka, Japan
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Sakai, Japan
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Sapporo, Japan
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Sendai, Japan
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Wakayama, Japan
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Yokohama, Japan
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Bystra, Poland
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Olsztyn, Poland
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Poznan, Poland
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Warsaw, Poland
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Rio Piedras, Puerto Rico
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San Juan, Puerto Rico
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Goyang-si, South Korea
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Namdong-gu, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Suwon, South Korea
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A Coruña, Spain
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Barcelona, Spain
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Granada, Spain
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Madrid, Spain
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Majadahonda, Spain
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Valencia, Spain
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Dusit, Thailand
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Hat Yai, Thailand
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Udon Thani, Thailand
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Adapazarı, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Goztepe Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Küçükçekmece, Turkey (Türkiye)
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Seyhan, Turkey (Türkiye)
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Hanoi, Vietnam
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Hà Nội, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Vinh, Vietnam
Trial contact
AstraZeneca Clinical Study Information Center
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/27/2026.
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