A Phase 2 interventional study of Osimertinib Mesylate in Non Small Cell Lung Cancer, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Phase 2, Interventional, and Treatment
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.
Advanced non-small cell lung cancer (NSCLC) accounts for a high proportion of lung cancer cases. Targeted therapy improve the survival in these patients, but acquired drug resistance will inevitably occur. If tumor downstaging is achieved after targeted therapy, could surgical resection before drug resistance improve clinical benefits for patients with advanced NSCLC? Here, the investigators conducted a clinical trial showing that for patients with advanced driver gene mutant NSCLC who did not progress after targeted therapy, salvage surgery (SS) could improve progression-free survival (PFS).
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 30 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 172 studies on the registry; 136 are open to participants now.
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Exclusion Criteria:
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
Progression-Free Survival
Time frame: 3 year
OS
Overall Survival
Time frame: 3 year
Resectability rate
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Osimertinib
Carcinoma, Non-Small-Cell Lung →
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology →