Real-World Study on Gene Profile in Patients With Advanced NSCLC Who Progressed on First-Line Osimertinib Therapy(GPS).

Phase 4

Completed

Conditions: Advanced NSCLC

Registration Number: NCT05219162

Lead Sponsor: AstraZeneca

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."

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 182

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Gene Alterations inTissue Detected by NGS	At enrollment	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%.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Gene Alterations in Plasma Detected by NGS	At enrollment	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%.
EGFR Sensitivity of Plasma and Tissue	At enrollment	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%
EGFR Specificity of Plasma and Tissue	At enrollment	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%.
EGFR PPV of Plasma and Tissue	At enrollment	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%
EGFR NPV of Plasma and Tissue	At enrollment	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%.
The Percentage of Pathology Transformation	At enrollment	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%.