Spots Global Cancer Trial Database for Real-World Study on Gene Profile in Patients With Advanced NSCLC Who Progressed on First-Line Osimertinib Therapy(GPS).
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Trial Identification
Brief Title: Real-World Study on Gene Profile in Patients With Advanced NSCLC Who Progressed on First-Line Osimertinib Therapy(GPS).
Official Title: Gene Profile in EGFRm Locally Advanced or Metastatic NSCLC Patients Post Osimertinib 1L Treatment Failure: A Real-world, Multi-center Study (GPS)
Study ID: NCT05219162
Conditions
Interventions
Study Description
Brief Summary: Although some small sample studies have reported the possible resistance mechanisms of Osimertinib in the first-line treatment, it is still an urgent need to explore the whole gene profile in EGFRm advanced NSCLC patients post Osimertinib 1L treatment by paired tissue and plasma to guide subsequent treatment strategy. Thus, the gene profile post Osimertinib 1L treatment in tissue and plasma may help to guide the following treatment. Participants will be required to provide paired tissue and whole blood after disease progression following 1L Osimertinib. 200 tissue samples and 200 whole blood samples will be used to detect gene alteration by NGS, respectively. 200 tissue samples will be used to detect pathological transformation by IHC. Approximately 80-100 tissue samples will be used to test MET overexpression by MET IHC and MET amplification by FISH respectively. Approximately 80-100 whole blood samples will be used to test MET amplification by ddPCR.
Detailed Description: "Tumor tissue samples will be obtained by biopsy."
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Beijing, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Dalian, , China
Research Site, Foshan, , China
Research Site, Fuzhou, , China
Research Site, Harbin, , China
Research Site, Hefei, , China
Research Site, Hefei, , China
Research Site, Linhai, , China
Research Site, Luoyang, , China
Research Site, Rizhao, , China
Research Site, Shanghai, , China
Research Site, Taizhou, , China
Research Site, Tianjin, , China
Research Site, Zhengzhou, , China
Contact Details
Name: Yuankai Shi, PhD
Affiliation: Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Role: PRINCIPAL_INVESTIGATOR
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