Efficacy of Erlotinib in Neoadjuvant Setting in Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01130753|
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : May 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms Erlotinib Neoadjuvant Therapy||Drug: Erlotinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2007|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2012|
- Pathologic down-staging [ Time Frame: 36 months ]
- Response rate [ Time Frame: 36 months ]
- Toxicity [ Time Frame: 36 months ]
- Progression free survival [ Time Frame: 36 months ]
- Overall survival [ Time Frame: 36 months ]
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): NCT01130753
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|