Salvage Surgery Following Downstaging of Advanced Non-small Cell Lung Cancer by Targeted Therapy (SDANT)

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT05085054
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the safety and efficacy of neoadjuvant targeted therapy followed by surgery in participants with advanced non-small cell lung cancer.

Key Dates

Start date
Jun 1, 2022
Status verified
May 2022
Primary completion
May 1, 2024
Completion
Aug 1, 2024

Study Design

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

Arms

  • Experimental: targeted therapy+salvage surgery
    Participants treated with targeted therapy without progression and radiological confirmation of tumor downstaging (≤stage IIIA) by PET-CT followed by salvage surgery were enrolled into the group of targeted therapy plus salvage surgery. The molecular targeted agents used in our study included osimertinib (80 mg, once a day) . Salvage surgery was defined as surgical intervention based on standard operation (lobectomy plus lymphadenectomy) of NSCLC for advanced patients who initially had no surgical indications, but achieved significant downstaging (≤stage IIIA) without progression after targeted therapy. Targeted therapy was continued after salvage surgery until progression.

Primary Outcome Measure

PFS [ Time Frame: 3 year ]

Central Contacts

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