NCT05219162

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

Gene Profile in EGFRm Locally Advanced or Metastatic NSCLC Patients Post Osimertinib 1L Treatment Failure: A Real-world, Multi-center Study (GPS)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 86 Years
• Healthy volunteers: Not accepted

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."

Conditions

• Advanced NSCLC

Interventions

Type	Name	Description
GENETIC	Gene Profile explore	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.

Timeline

• Start date: 2022-02-25
• Primary completion: 2024-04-29
• Completion: 2024-04-29
• First posted: 2022-02-01
• Last updated: 2025-09-11
• Results posted: 2025-09-11

Locations

16 sites across 1 country: China