This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer. The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment, and then surgery will be provided for patients who are suitable for primary tumor resection.
Shandong Public Health Clinical Center
Jinan, Shangdong, China
RECRUITINGThe rate of NSCLC converting to resectable tumors
The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy.
Time frame: Up to 12 weeks
R0 resection rate
The proportion of R0 resection in patients who receive surgery
Time frame: immediately after the surgery
Major pathologic response (MPR) Rate
The proportion of patients who achieve MRP among those receiving surgery
Time frame: Up to 12 weeks
Pathologic complete response (pCR) Rate
The proportion of patients who achieve pCR among those receiving surgery
Time frame: Up to 12 weeks
Tumor downstaging rate
The proportion of patients who reach the successful downstaging criteria for NSCLC
Time frame: Up to 12 weeks
Objective response rate (ORR)
The proportion of patients who have a complete response (CR) or partial response (PR).
Time frame: Up to five years
Disease control rate (DCR)
The proportion of patients who have a best overall response of CR, PR, or stable disease (SD).
Time frame: Up to five years
Event-free survival (EFS)
The length of time after initial administration the patient remains free of recurrence/progression or death, whatever the cause.
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Time frame: Up to five years
The 2-year progression-free survival (PFS) rate
The proportion of patients who are event-free.
Time frame: Up to two years
Overall Survival (OS)
The length of time after initial administration the patient remains alive
Time frame: Up to five years