Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03720873
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
EGFR Gene Mutation Drug: erlotinib or gefitinib or icotinib Drug: Anlotinib Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EGFR-TKIs and 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
Drug: erlotinib or gefitinib or icotinib
Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TID

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




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 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 :
  1. Objective response [ Time Frame: 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.

  2. Safety - Adverse events graded according to NCI CTCAE V4.03 [ Time Frame: 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

  3. Overall survival [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720873


Contacts
Layout table for location contacts
Contact: Zhiyong He, master 13805086391 heyong1015@163.com

Locations
Layout table for location information
China, Fujian
Fujian cancer hospital Recruiting
Fuzhou, Fujian, China
Contact: Zhiyong He, master    0086-591-83660063      
Sponsors and Collaborators
Fujian Cancer Hospital
Investigators
Layout table for investigator information
Principal Investigator: Zhiyong He, master Fujian Cancer Hospital

Publications of Results:
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

Layout table for additonal information
Responsible Party: Fujian Cancer Hospital
ClinicalTrials.gov Identifier: NCT03720873     History of Changes
Other Study ID Numbers: secgolc004
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Erlotinib Hydrochloride
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action