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."
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
182
The tissue and blood sample for this genetic research will be obtained from the participants at baseline(disease progression after 1L Osimertinib). Paired tissue and whole blood sample should be collected per participant for genetics during the study.
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
...and 6 more locations
Percentage of Participants With Gene Alterations inTissue Detected by NGS
The Percentage of gene alteration detected by NGS(%) = (number of patients with gene alteration detected by NGS)/(total number of patients in the FAS)×100%.
Time frame: At enrollment
Percentage of Participants With Gene Alterations in Plasma Detected by NGS
The percentage of gene alteration detected by NGS(%) = (number of patients with gene alteration detected by NGS)/(total number of patients in the FAS)×100%.
Time frame: At enrollment
EGFR Sensitivity of Plasma and Tissue
Tissue sample was the reference standard. -sensitivity=(number of patients with positive result in both plasma and tissue)/(total number of patients with positive result in tissue samples)×100%
Time frame: At enrollment
EGFR Specificity of Plasma and Tissue
Tissue sample was the reference standard. \- specificity=(number of patients with negative result in both plasma and tissue)/(total number of patients with negative result in tissue samples)×100%.
Time frame: At enrollment
EGFR PPV of Plasma and Tissue
Tissue sample was the reference standard. PPV (%)=(number of patients with positive result in both plasma and tissue)/(total number of patients with positive result in plasma samples)×100%
Time frame: At enrollment
EGFR NPV of Plasma and Tissue
Tissue sample was the reference standard. \- NPV (%)=(number of patients with negative result in both plasma and tissue)/(total number of patients with negative result in plasma samples)×100%.
Time frame: At enrollment
The Percentage of Pathology Transformation
Pathology transformation was defined as those transformation from non-small-cell lung cancer to small-cell lung cancer or from adenocarcinoma to squamous carcinoma, can be observed by IHC Proportion of pathology transformation(%) = (number of patients with pathology transformation)/(total number of patients in the FAS)×100%.
Time frame: At enrollment
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