The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
The LACE meta-analysis identified four cycles of platinum-based program to improve II\~IIIA stage completely resected NSCLC pts the role of 5-year survival, but its treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary adenocarcinoma carrying EGFR activating mutations in the metastatic setting. The aim of this study is to investigate the efficacy and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in pts with stage IIIA NSCLC after Complete Resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGChinese PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGDisease-free survival
To evaluate Disease-free survival(DFS) of two groups
Time frame: 2 years
Number of Participants with Adverse Events
To evaluate the safety profile(Number of Participants with Adverse Events) of two group.
Time frame: 2 years
Quality of Life (QOL)
To evaluate the Quality of Life (QOL) of two group.
Time frame: 2 years
overall survival (OS)
To evaluate the overall survival (OS) of two groups
Time frame: 2 years
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGHebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGThe First Affiurted Hospital of Soochow University
Suzhou, Jiangsu, China
NOT_YET_RECRUITINGQingdao University Medical College
Qingdao, Shandong, China
NOT_YET_RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGThe Second People's Hospital of Sichuan
Chengdu, Sichuang, China
RECRUITINGTianjin Medical University Cancer Institute and Hospital
Tianji, Tianji, China
RECRUITING...and 1 more locations