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

Phase 2

• Conditions: EGFR Gene Mutation
• Interventions: Drug: erlotinib or gefitinib or icotinib; Drug: Anlotinib

• Registration Number: NCT03720873
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

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

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

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-24
• Last Update Submitted: 2018-10-24
• Study First Posted: 2018-10-25
• Last Update Posted: 2018-10-25
• Primary Completion: 2021-06
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EGFR-TKIs and Anlotinib	erlotinib or gefitinib or icotinib	Experimental:EGFR-TKIs and Anlotinib EGFR-TKIs:erlotinib 150mg QD or gefitinib250mgQD or icotinib 125 mg TID , Anlotinib 12mg po qd d1-14 q21d
EGFR-TKIs and Anlotinib	Anlotinib	Experimental:EGFR-TKIs and Anlotinib EGFR-TKIs:erlotinib 150mg QD or gefitinib250mgQD or icotinib 125 mg TID , Anlotinib 12mg po qd d1-14 q21d

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival	Three years	Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit.
Objective response	through study completion,an average of three years	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.
Safety - 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	Adverse events graded according to NCI CTCAE V4.03

Trial Locations

Locations (1)

Fujian cancer hospital; 🇨🇳 Fuzhou, Fujian, China