Study identifier:D5161R00037
ClinicalTrials.gov identifier:NCT05219162
EudraCT identifier:N/A
CTIS identifier:N/A
Gene Profile in EGFRm Locally Advanced or Metastatic NSCLC patients post Osimertinib 1L treatment failure: A real-world, multi-center Study (GPS)
advanced NSCLC
Phase 4
No
-
All
182
Interventional
18 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Diagnostic
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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.
"Tumor tissue samples will be obtained by biopsy."
Location
Location
Linhai, China, 317000
Location
Foshan, China, 528000
Location
Tianjin, China, 300060
Location
Zhengzhou, China, 450000
Location
Harbin, China, 150081
Location
Fuzhou, China, 350014
Location
Dalian, China, 116023
Location
rizhao, China, 276826
Arms | Assigned Interventions |
---|---|
Other: EGFRm Locally Advanced or Metastatic NSCLC patients post Osimertinib 1L treatment failure participants with advanced or metastatic non-small cell lung cancer, who have already taken osimertinib as a first treatment option, but their cancer has continued to get worse | - |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.