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

Sponsor
Jin Ying
Study ID
NCT06530719
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
Jul 2024
Primary completion
May 31, 2026
Completion
May 31, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib group
    Experimental: Osimertinib 80mg QD All patients will only receive Osimertinib 80mg QD. Dose may be reduced to allow for the management of related toxicity.

Primary Outcome Measure

Objective remission rate evaluated by the investigator (ORR) [ Time Frame: Follow-up until treatment duration reached 3 years, disease progression, or other treatment termination criteria were met ]

Central Contacts

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