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Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer

EGF-R Positive Non-Small Cell Lung Cancer Clinical Trial

Official title:
Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer: a Single Arm, Phase II Clinical Study

Clinical Trial Summary

The main purpose of this study is to evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy in EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery.

Clinical Trial Description

Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy; then they receive surgical resection of the tumor. If there is curative effect of Icotinib according to the RECIST or pathological report, the patients will continue receive Icotinib for two years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. The primary objective of this study is evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03349203
Study type Interventional
Source Betta Pharmaceuticals Co.,Ltd.
Contact Shugeng Gao, MD
Phone 13801185056
Email gaoshugeng@vip.sina.com
Status Recruiting
Phase Phase 2
Start date October 1, 2018
Completion date December 30, 2023
View Details
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