EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC

Study Overview
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Brief Summary
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A single arm study: EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant non-small-cell lung cancer (NSCLC).

Detailed Description
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This trial investigated the efficacy and safety of EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant NSCLC.

Official Title
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An Multicenter,Phase II Trial of EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC

Conditions
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EGFR Gene Mutation

Intervention / Treatment
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* Drug: erlotinib or gefitinib or icotinib
* Drug: Anlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Age ≥ 18 years ECOG performance status 0-1 Adequate haematological function, coagulation, liver function and renal function Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC) TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease) Measurable or evaluable disease (according to RECIST 1.1 criteria). 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. Patients with any known significant ophthalmologic anomaly of the ocular surface Patients who received prior chemotherapy for metastatic disease CNS metastases Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGFR-TKIs and Anlotinib<br>Experimental:EGFR-TKIs and Anlotinib EGFR-TKIs:erlotinib 150mg QD or gefitinib250mgQD or icotinib 125 mg TID , Anlotinib 12mg po qd d1-14 q21d | Drug: erlotinib or gefitinib or icotinib<br>* Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TID<br>Drug: Anlotinib<br>* Patients will be treated with Anlotinib 12mg po d1-14 Q21d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Time from the date of enrolment to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death) | within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | Three years |