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Brief Title: To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations
Official Title: A Phase II, Open-label, Single-arm Study of Osimertinib as Induction Therapy Prior to CRT and Maintenance Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Stage III, Unresectable Non-small Cell Lung Cancer (NEOLA)
Study ID: NCT06194448
Brief Summary: The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent CRT and maintenance osimertinib in adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).
Detailed Description: The study duration will be approximately 2 years for recruitment and 2 years of follow-up from the last patient's initiation into the study. The induction treatment with osimertinib will be up to 8 weeks, followed by 6 weeks of CRT treatment and osimertinib maintenance treatment until PD or death. The visit frequency will be every 2 weeks to 4 weeks during the induction treatment period, every 3 weeks during the CRT period (every 3 weeks for chemotherapy and daily visits for RT)), and every 12 weeks during the osimertinib maintenance treatment period.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, La Jolla, California, United States
Research Site, Los Angeles, California, United States
Research Site, Palo Alto, California, United States
Research Site, Brooklyn, New York, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Beijing Shi, , China
Research Site, Changsha, , China
Research Site, Guangzhou, , China
Research Site, Hangzhou, , China
Research Site, Harbin, , China
Research Site, Hefei, , China
Research Site, Jinan, , China
Research Site, Nanning, , China
Research Site, Shanghai, , China
Research Site, Shaoguan Shi, , China
Research Site, Tianjin Shi, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Xi'an, , China
Research Site, Zhengzhou, , China
Research Site, Gurgaon, , India
Research Site, Mohali, , India
Research Site, Mumbai, , India
Research Site, New Delhi, , India
Research Site, Pune, , India
Research Site, Haifa, , Israel
Research Site, Jerusalem, , Israel
Research Site, Petach-Tikva, , Israel
Research Site, Tel Aviv, , Israel
Research Site, Cheongju-si, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon, , Korea, Republic of
Research Site, Badalona, , Spain
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Donostia-San Sebastian, , Spain
Research Site, Granada, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Valencia, , Spain
Research Site, Hsinchu, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan City, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Bangkok, , Thailand
Research Site, Bangkok, , Thailand
Research Site, Chiang Rai, , Thailand
Research Site, Hat Yai, , Thailand
Research Site, Khlong Toey, , Thailand
Research Site, Khon Kaen, , Thailand
Research Site, Lampang, , Thailand
Research Site, Naimuang, , Thailand
Research Site, Rachathewi, , Thailand
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Edirne, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Izmir, , Turkey
Research Site, Yenimahalle, , Turkey
Research Site, Yenimahalle, , Turkey
Research Site, Hanoi, , Vietnam
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh, , Vietnam