A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations

Hebei Medical University Fourth Hospital1 site in 1 country80 target enrollmentAugust 15, 2018

ConditionsNSCLC

InterventionsApatinib

DrugsApatinib

Overview

Phase: Not Applicable
Intervention: Apatinib
Conditions: NSCLC
Sponsor: Hebei Medical University Fourth Hospital
Enrollment: 80
Locations: 1
Primary Endpoint: Progression free survival
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of apatinib plus EGFR-TKI as first line treatment in patients with non-squamous NSCLC harboring EGFR mutation.

Registry

clinicaltrials.gov

Start Date

August 15, 2018

End Date

August 15, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hebei Medical University Fourth Hospital

Responsible Party

Principal Investigator

LiuJunFeng

Principal Investigator

Hebei Medical University Fourth Hospital

Eligibility Criteria

Inclusion Criteria

•Age:18 to 75 years old (man or female);
•Pathologically diagnosed with non-squamous NSCLC;
•Imageology diagnosed with locally advanced/metastatic or recurrent (stage ⅢB - IV);
•Histologically or cytologic confirmed，harboring an activating EGFR mutation (19del or 21 L858R);
•None previous chemotherapy or targeted therapy.（NOTE: neoadjuvant and adjuvant therapy is allowed）;
•At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1)；
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
•Major organ function has to meet the following criteria:
•ANC≥1.5×109/L；
•PLT≥80×109/L；

Exclusion Criteria

•Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
•Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)\<50%;
•Radiologically documented evidence of major blood vessel invasion or encasement by cancer;
•A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
•Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (++). Has melena and hematemesis in two months;
•Coagulant function abnormality (INR \> 1.5 ULN, APTT \> 1.5 ULN), with bleeding tendency;
•Patients with pregnant or planning a pregnancy;
•Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ);
•History of psychiatric drugs abuse and can't quit or patients with mental disorders;
•Less than 4 weeks from the last clinical trial;

Arms & Interventions

apatinib

apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po

Intervention: Apatinib

Outcomes

Primary Outcomes

Progression free survival

Time Frame: evaluated in two years since the treatment began

Baseline to measured date of progression or death from any cause

Secondary Outcomes

Objective response rate(tumor assessment every 8 weeks，up to two years)
Adverse events(evaluated in the two years since the treatment began according to the Common Terminology Criteria for Adverse Events Version 4.0)
Overall survival (OS)(the first day of treatment to death or last survival confirm date，up to two years)
Disease control rate (DCR)(tumor assessment every 8 weeks，up to two years)