This single-arm phase II study aims to study the efficacy of a possible first line treatment that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this new combinational therapy can benefit short-term and long-term survival of the patients with advanced NSCLC.
Based on NCCN guideline of the epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) such as erlotinib, gefitinib and icotinib as the first line treatment for advanced Non-Small Cell Lung Cancer (NSCLC), the efficacy of EGFR-TKIs in combination with thoracic radiotherapy as the first line treatment for stage IV NSCLC with active EGFR mutation remains unknown. In this single-arm phase II trial, we chose the subjects with stage IV harboring active EGFR mutation,who were treated by EGFR-TKIs combined with radiation therapy. The primary endpoint is 1-year rate of progression-free survival and the second endpoints are overall survival (OS), objective response rate and toxic and side effect. By evaluating them, we expect to find out the evidence that the combination therapy can benefit the short-term and long-term survival of the patients. Meanwhile, via the stratification analysis of tumor biomarker and immune index, we obtain the evidences for the benefits of comprehensive and individual treatment for advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Beginning on day 2 of treatment, receive oral erlotinib 150mg per day.
From the beginning of EGFR-TKIs, within 2 weeks, receive concurrent thoracic radiotherapy, pGTV54~60Gy/27~30f/5.5~6w.
Xinqiao Hospital of Chongqing
Chongqing, China
1-year rate of progression-free survival
1-year rate of progression-free survival
Time frame: one year after treatment, followed
Overall survival (OS)
Overall survival (OS)
Time frame: From the time of study enrollment until the date of death
Objective response rate
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: up to three years
Disease control rate
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: up to three years
patients quality of life
Assessed by EORTC-QLQ C30
Time frame: up to three years
Failure mode
The number of patients who failed the treatment of EGFR-TKIs with thoracic radiotherapy.
Time frame: up to three years
Toxicities associated with combined erlotinib and concurrent thoracic radiotherapy. Assessed by Common Terminology Criteria for Adverse Events(CTCAE)
Assessed by Common Terminology Criteria for Adverse Events(CTCAE)
Time frame: up to three years
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