NCT06530719

A Study to Evaluate the Efficacy of Osimertinib in Patients With EGFR-sensitive Mutated Non-small Cell Lung Cancer Progression After Receiving Adjuvant Targeted Therapy Following Radical Surgery

A Prospective, Single-arm, Single-center, Phase II Study to Evaluate the Efficacy of Osimertinib in Patients With EGFR-sensitive Mutated Non-small Cell Lung Cancer Progression After Receiving Adjuvant Targeted Therapy Following Radical Surgery

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Jin Ying · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study aims to verify the efficacy and safety of osimertinib in patients with EGFR-sensitive mutation non-small cell lung cancer who progressed after adjuvant targeted therapy following radical surgery. The main questions it aims to answer is: whether EGFR-TKI is effective in the re-treatment of NSCLC after postoperative adjuvant targeted therapy relapse.

Detailed description

Generic name: Osimertinib mesylate Dosage form: tablets Specifications: 80 mg tablets; 30 tablets/box Usage: Oral, once daily, one tablet at a time Duration of drug administration: until the duration of treatment reaches 3 years, the disease progresses, or other treatment termination criteria are met Primary study endpoint: Objective remission rate evaluated by the investigator (ORR) Secondary study endpoint: Progression-free survival (PFS), duration of response (DoR), disease control rate (DCR), overall survival (OS) and tumor response depth (DepOR) as evaluated by the investigator Safety: Adverse events (AE), clinical laboratory numerical evaluation

Conditions

• Lung Neoplasms
• Lung Cancer, Nonsmall Cell

Interventions

Type	Name	Description
DRUG	Osimertinib mesylate	Osimertinib mesylate , 80mg QD，until the duration of treatment reaches 3 years, the disease progresses, or other treatment termination criteria are met

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-05-01
• Completion: 2028-05-01
• First posted: 2024-07-31
• Last updated: 2024-07-31