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
• Interventions: Genetic: Gene Profile explore

• 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."

Study Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-01
• Study Start: 2022-02-25
• Status Verified: 2024-05
• Primary Completion: 2024-05-09
• Study Completion: 2024-05-09
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

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

Arm && Interventions

Group	Intervention	Description
EGFRm Locally Advanced or Metastatic NSCLC patients post Osimertinib 1L treatment failure	Gene Profile explore	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

Primary Outcome Measures

Name	Time	Method
Gene profile in tissue	up to 2 weeks	⚫ Gene profile in tissue Gene profile defined as gene alternation detected by NGS and frequency of every gene alternation.; All gene alterations include gene mutation, copy number variation(CNV), fusion, etc.; The frequency of all gene alteration detected by NGS(%) = (number of patients with every gene alteration detected by NGS)/(total number of patients in the FAS)×100%.

Secondary Outcome Measures

Name	Time	Method
Concordance of plasma and tissue	up to 2 weeks	Using selected representative genes (for example EGFR, MET, PIK3CA and etc.) to measure the concordance.
The percentage of pathology transformation	up to 2 weeks	Pathology transformation is 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
Gene profile in plasma	up to 2 weeks	Gene profile defined as gene alternation detected by NGS and frequency of every gene alternation.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China