A single arm study: EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant non-small-cell lung cancer (NSCLC).
This trial investigated the efficacy and safety of EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TID
Patients will be treated with Anlotinib 12mg po d1-14 Q21d
Fujian cancer hospital
Fuzhou, Fujian, China
RECRUITINGProgression free survival
Time from the date of enrolment to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death)
Time frame: within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient
Objective response
Best overall response (complete remission or partial remission) across all assessment time-points according to RECIST Criteria 1.1, during the period from enrolment to termination of trial treatment.
Time frame: through study completion,an average of three years
Safety - Adverse events graded according to NCI CTCAE V4.03
Adverse events graded according to NCI CTCAE V4.03
Time frame: within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient
Overall survival
Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit.
Time frame: Three years
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