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

NCT03634059 | Unknown

• 1 other identifier: HRA-L01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Baseline to measured date of progression or death from any cause

  evaluated in two years since the treatment began

Secondary Outcomes (4)

• Objective response rate

  tumor assessment every 8 weeks，up to two years

• Disease control rate (DCR)

  tumor assessment every 8 weeks，up to two years

• Overall survival (OS)

  the first day of treatment to death or last survival confirm date，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

Study Arms (1)

apatinib

EXPERIMENTAL

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

Drug: Apatinib

Interventions

Apatinib DRUG

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

apatinib

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 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:
• HB≥90g/L；
• ANC≥1.5×109/L；
• PLT≥80×109/L；
• ALT and AST≤2.5ULN, but≤5ULN if the transferanse elevation is due to liver metastases;
• TBIL≤1.5ULN;
• Serum creatinine≤1.25ULN; Endogenous creatinine clearance rate\>45 ml/min;
• Life expectancy greater than or equal to 3 months;

You may not qualify if:

• 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;
• The researchers think inappropriate.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Junfeng Liu

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Interventions

apatinib

Study Officials

• Junfeng Liu

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junfeng Liu, Professor

CONTACT

13931152296; 13931152296@126.com

Junfeng Liu

CONTACT

13931152296; 13931152296@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 16, 2018
• Study Start: August 15, 2018
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2020
• Last Updated: August 16, 2018

Record last verified: 2018-07

Locations

CN (1)