A single arm study: EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant non-small-cell lung cancer (NSCLC).
Name: erlotinib or gefitinib or icotinib
Description: Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TIDType: DrugEGFR-TKIs and Anlotinib
Name: Anlotinib
Description: Patients will be treated with Anlotinib 12mg po d1-14 Q21dType: DrugEGFR-TKIs and Anlotinib
Description: Time from the date of enrolment to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death)
Measure: Progression free survival Time: within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patientDescription: 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.
Measure: Objective response Time: through study completion,an average of three yearsDescription: Adverse events graded according to NCI CTCAE V4.03
Measure: Safety - Adverse events graded according to NCI CTCAE V4.03 Time: within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patientDescription: Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit.
Measure: Overall survival Time: Three yearsSingle Group Assignment
There is one SNP
- Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R) Exclusion Criteria: - - Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma. --- L858R ---