Efficacy of Erlotinib in Neoadjuvant Setting in Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Neoadjuvant Erlotinib (Tarceva®) Followed by Surgery for Selected Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer|
- Pathologic down-staging [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Progression free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
It is widely accepted that patients with locally advanced non-small cell lung cancer would have better outcome with neoadjuvant therapy followed by surgery than surgery alone. However what should be the standard treatment option is still unclear.
Erlotinib (Tarceva®)is an oral inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase and its anti-neoplastic effect is approved especially women, patients with adenocarcinoma, non-smoker and Asian population. Moreover if the malignant tissue has EGFR mutation, its efficacy is known to be enhanced.
So we expect that in those population, patients with locally advanced, N2 positive, erlotinib would be more beneficial than conventional cytotoxic chemotherapy in safety and convenience as neoadjuvant therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130753
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|