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
NCT Number: NCT06530719
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lung Neoplasms|Lung Cancer, Nonsmall Cell
Interventions: DRUG: Osimertinib mesylate
Sponsor: Jin Ying
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-05

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.

Primary Outcome Measures: Objective remission rate evaluated by the investigator (ORR), Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with at least 1 visit response of Complete Response or Partial Response., Follow-up until treatment duration reached 3 years, disease progression, or other treatment termination criteria were met
Secondary Outcome Measures: Progression-free survival (PFS) evaluated by the investigator, Progression-free survival (PFS) is defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression., Follow-up until treatment duration reached 3 years, disease progression, or other treatment termination criteria were met|Duration of response (DoR) evaluated by the investigator, Duration of Response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression., Follow-up until treatment duration reached 3 years, disease progression, or other treatment termination criteria were met|Disease control rate (DCR) evaluated by the investigator, Disease control rate (DCR) is defined as the percentage of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator., Follow-up until treatment duration reached 3 years, disease progression, or other treatment termination criteria were met|Overall survival (OS) evaluated by the investigator, Overall survival is defined as the time from the date of randomization until death due to any cause., Follow-up until treatment duration reached 3 years, disease progression, or other treatment termination criteria were met|Tumor response depth (DepOR) evaluated by the investigator, Depth of response (ie. tumor shrinkage / change in tumor size) by Investigator is defined as the relative change in the sum of the longest diameters of Response Evaluation Criteria in Solid Tumors (RECIST) target lesions at the nadir in the absence of New Lesions (NLs) or progression of Non-Target Lesions when compared to baseline., Follow-up until treatment duration reached 3 years, disease progression, or other treatment termination criteria were met|Adverse events (AE), Adverse events (AE), Follow-up until treatment duration reached 3 years, disease progression, or other treatment termination criteria were met