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

EGFR Gene Mutation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720873
• Other study ID #: secgolc004
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2018
• Est. completion date: September 2022

Study information

• Verified date: October 2018
• Source: Fujian Cancer Hospital
• Contact: Zhiyong He, master
• Phone: 13805086391
• Email: heyong1015[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• EGFR Gene Mutation

Intervention

Drug:
• erlotinib or gefitinib or icotinib
Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TID
• Anlotinib
Patients will be treated with Anlotinib 12mg po d1-14 Q21d

Locations

Country	Name	City	State
China	Fujian cancer hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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