AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Launched by ASTRAZENECA · May 30, 2014
Trial Information
Current as of April 27, 2025
Completed
Keywords
ClinConnect Summary
This is a phase III, open label, randomized study assessing Osimertinib (80 mg, orally, once daily) versus platinum-based doublet chemotherapy (standard of care) in subjects with confirmed diagnosis of Epidermal Growth Factor Receptor (EGFR) mutation positive NSCLC, who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent and whose tumours harbour a T790M mutation within the EGFR Gene. Subjects must be chemotherapy naive and must agree to provide a biopsy for central confirmation of T790 mutation status followin...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subjects with histologically or cytologically documented NSCLC.
- • Locally advanced or metastatic NSCLC
- • Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment
- • Eligible to receive treatment with the selected doublet-chemotherapy
- • Central confirmation of T790M+ mutation status
- • World Health Organization (WHO) performance status 0-1
- • At least one lesion, not previously irradiated.
- Exclusion Criteria:
- • • Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
- • Treatment with more than one prior line of treatment for advanced NSCLC
- • Treatment with an approved EGFR-TKI (e.g.,erlotinib, gefitinib, afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment
- • Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
- • Previous treatment with Osimertinib, or a 3rd generation EGFR TKI
- For subjects who cross-over to Osimertinib:
- • Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review.
- • At least 14 days since last dose of platinum-based doublet chemotherapy
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Hong Kong, , Hong Kong
Indianapolis, Indiana, United States
Pembroke Pines, Florida, United States
Lacey, Washington, United States
Omsk, , Russian Federation
Moscow, , Russian Federation
Sevilla, , Spain
Tacoma, Washington, United States
Orlando, Florida, United States
Milano, , Italy
Zaragoza, , Spain
Manchester, , United Kingdom
Gainesville, Florida, United States
Park Ridge, Illinois, United States
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Lille, , France
Lund, , Sweden
Wolverhampton, , United Kingdom
New York, New York, United States
Avellino, , Italy
Edinburgh, , United Kingdom
Heidelberg, , Australia
Essen, , Germany
Regensburg, , Germany
Málaga, , Spain
Orange, California, United States
Anaheim, California, United States
Marrero, Louisiana, United States
Lebanon, New Hampshire, United States
Groningen, , Netherlands
Brick, New Jersey, United States
Orbassano, , Italy
Milwaukee, Wisconsin, United States
Atlanta, Georgia, United States
Charleston, South Carolina, United States
Paris, , France
Oldenburg, , Germany
Würzburg, , Germany
Madrid, , Spain
Nottingham, , United Kingdom
Amsterdam, , Netherlands
Stockholm, , Sweden
Ottawa, Ontario, Canada
Dijon, , France
Frankfurt, , Germany
Halifax, Nova Scotia, Canada
Tainan, , Taiwan
Budapest, , Hungary
Glasgow, , United Kingdom
Santa Rosa, California, United States
Chevy Chase, Maryland, United States
Beijing, , China
Oaxaca, , Mexico
Kaohsiung, , Taiwan
Taichung, , Taiwan
Clermont Ferrand, , France
Roma, , Italy
Tianjin, , China
Bristol, , United Kingdom
Seoul, , Korea, Republic Of
Nagoya Shi, , Japan
Niigata Shi, , Japan
Suwon Si, , Korea, Republic Of
Taipei, , Taiwan
Strasbourg Cedex, , France
Matsuyama Shi, , Japan
Mexico, , Mexico
Changhua, , Taiwan
Toulouse Cedex 09, , France
Hershey, Pennsylvania, United States
Sunto Gun, , Japan
Norwalk, Connecticut, United States
Fukuoka, , Japan
London, , United Kingdom
Hangzhou, , China
Shanghai, , China
ürümqi, , China
Osakasayama, , Japan
Sakai Shi, , Japan
Jinju Si, , Korea, Republic Of
Guangzhou, , China
Seongnam Si, , Korea, Republic Of
Darlinghurst, , Australia
Nanchang, , China
Busan, , Korea, Republic Of
Cheongju Si, , Korea, Republic Of
Kaohsiung City, , Taiwan
Göteborg, , Sweden
Kogarah, , Australia
Nedlands, , Australia
Villejuif, , France
Hirakata Shi, , Japan
Kanazawa, , Japan
Kobe Shi, , Japan
Okayama Shi, , Japan
Shinjuku Ku, , Japan
Takatsuki Shi, , Japan
Meldola, , Italy
Newcastle Upon Tyne, , United Kingdom
Changchun, , China
Fuzhou, , China
Zhengzhou, , China
Kitaadachi Gun, , Japan
Taoyuan, , Taiwan
Marseille Cedex 20, , France
Gerlingen, , Germany
Saint Petersburg, , Russian Federation
Aberdeen, , United Kingdom
Kyoto Shi, , Japan
Hsinchu, , Taiwan
Incheon, , Korea, Republic Of
Goyang Si, , Korea, Republic Of
Akashi Shi, , Japan
Natori Shi, , Japan
Osaka Shi, , Japan
Shatin, , Hong Kong
Wakayama Shi, , Japan
Ulsan, , Korea, Republic Of
Woolloongabba, , Australia
Bunkyo Ku, , Japan
Chongqing, , China
Harbin, , China
Kurashiki Shi, , Japan
Yokohama Shi, , Japan
Ekaterinburg, , Russian Federation
Saint Petersburg,, , Russian Federation
Saint Petersburg, , Russian Federation
Huddersfield, , United Kingdom
Patients applied
Trial Officials
Yilong Wu, MD
Principal Investigator
Guangdong General Hospital, Guangdong, 510030, China
Vassiliki A Papadimitrakopoulou, MD
Principal Investigator
The University of Texas/M.D. Anderson Cancer Center, Houston, Tx, USA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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