The aim of this study is to investigate the efficacy and safety of intercalated combination of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced NSCLC, and to explore a new treatment strategy for this subset. After Induction by erlotinib, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance.
Chemoradiation therapy is the standard treatment for unresectable, locally advanced NSCLC, but its efficacy reaches a platform, and treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitors (TKIs) produce a dramatic response in patients carrying EGFR activating mutations in the metastatic setting. Multiple prospective trials show that EGFR-TKIs have a better tolerability when compared with chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Subjects receive erlotinib tablet 150mg orally once daily, after 12 weeks of induction phase, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance phase. At the end of maintenance, the subjects enter into the follow-up period.
Guangdong General Hospital
Guangzhou, Guangdong, China
Objective response rate
assessed by the RECIST 1.1 criteria
Time frame: Tumor response will be evaluated through study completion, an average of 6 weeks.
1 year survival rate
To evaluate the 1 year survival rate of the new strategy.
Time frame: Pts after maintenance phase will receive long-term follow-up including CT scan every 12 weeks for up to 10 years.
3 year survival rate
To evaluate the 3 year survival rate of the new strategy.
Time frame: Pts after maintenance phase will receive long-term follow-up including CT scan every 12 weeks for up to 10 years.
Progression free survival(PFS)
The product limit estimator developed by Kaplan and Meier will be used.
Time frame: Occurrence of local or regional progression, distant metastases, or death from any cause from the time of treatment to the occurrence of one of the failure events, whichever occurs first, assessed up to 10 years.
Overall survival
The product limit estimator developed by Kaplan and Meier will be used. Their 95% confidence intervals will be estimated.
Time frame: Time from treatment to death from any cause, assessed up to 10 years.
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