Salvage Surgery Following Downstaging of Advanced Non-small Cell Lung Cancer by Targeted Therapy (SDANT)
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|ClinicalTrials.gov Identifier: NCT05085054|
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Osimertinib Mesylate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction Therapy With Targeted Therapy Followed by Surgery for Stage IIIB and IV Non-small Cell Lung Cancer: a Multi-center, Single-arm, Prospective Clinical Study|
|Estimated Study Start Date :||November 1, 2021|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||August 1, 2024|
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.
Drug: Osimertinib Mesylate
Participants will receive targeted therapy followed by salvage surgery
- PFS [ Time Frame: 3 year ]Progression-Free Survival
- OS [ Time Frame: 3 year ]Overall Survival
- Resectability rate [ Time Frame: 1 year ]Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085054
|Contact: Yongde Liao, PhDemail@example.com|
|Contact: Guanchao Ye, PhDfirstname.lastname@example.org|