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

NCT03720873 | Unknown Phase 2 DMC

• 1 other identifier: secgolc004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

EGFR Gene Mutation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Objective response

  through study completion,an average of three years

• 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

• Overall survival

  Three years

Study Arms (1)

EGFR-TKIs and Anlotinib

EXPERIMENTAL

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; Drug: Anlotinib

Interventions

erlotinib or gefitinib or icotinib DRUG

Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TID

EGFR-TKIs and Anlotinib

Anlotinib DRUG

Patients will be treated with Anlotinib 12mg po d1-14 Q21d

EGFR-TKIs and Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian cancer hospital

Fuzhou, Fujian, China

RECRUITING

Related Publications (1)

• Maemondo M, Fukuhara T, Sugawara S, et al. NEJ026: Phase III study comparing bevacizumab plus erlotinib to erlotinib in patients with untreated NSCLC harboring activating EGFR mutations[J]. Annals of Oncology, 2016, 27

  RESULT

MeSH Terms

Interventions

Erlotinib Hydrochloride; Gefitinib; icotinib; anlotinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zhiyong He, master

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyong He, master

CONTACT

13805086391; heyong1015@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 25, 2018
• Study Start: October 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2022
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external indepentent Review Panel. Requesdtors will be required to sign a Data Access Agreement.

Locations

CN (1)