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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03634059
• Other study ID #: HRA-L01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: August 15, 2020

Study information

• Verified date: July 2018
• Source: Hebei Medical University Fourth Hospital
• Contact: Junfeng Liu, Professor
• Phone: 13931152296
• Email: 13931152296[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age:18 to 75 years old (man or female);

2. Pathologically diagnosed with non-squamous NSCLC;

3. Imageology diagnosed with locally advanced/metastatic or recurrent (stage ?B - IV);

4. Histologically or cytologic confirmed,harboring an activating EGFR mutation (19del or 21 L858R);

5. None previous chemotherapy or targeted therapy.(NOTE: neoadjuvant and adjuvant therapy is allowed);

6. At least one measurable lesion (measuring=10mm on spiral CT scan, satisfying the criteria in RECIST1.1);

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

8. Major organ function has to meet the following criteria:

1. HB=90g/L;

2. ANC=1.5×109/L;

3. PLT=80×109/L;

4. ALT and AST=2.5ULN, but=5ULN if the transferanse elevation is due to liver metastases;

5. TBIL=1.5ULN;

6. Serum creatinine=1.25ULN; Endogenous creatinine clearance rate>45 ml/min;

9. Life expectancy greater than or equal to 3 months;

10. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;

11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);

2. 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%;

3. Radiologically documented evidence of major blood vessel invasion or encasement by cancer;

4. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);

5. 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;

6. Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency;

7. Patients with pregnant or planning a pregnancy;

8. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ);

9. History of psychiatric drugs abuse and can't quit or patients with mental disorders;

10. Less than 4 weeks from the last clinical trial;

11. The researchers think inappropriate.

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• Apatinib
apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po

Locations

Country	Name	City	State
China	Junfeng Liu	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Baseline to measured date of progression or death from any cause	evaluated in two years since the treatment began
Secondary	Objective response rate	Baseline to measured stable disease	tumor assessment every 8 weeks,up to two years
Secondary	Disease control rate (DCR)	Baseline to measured progressive disease	tumor assessment every 8 weeks,up to two years
Secondary	Overall survival (OS)	Baseline to measured date of death from any cause	the first day of treatment to death or last survival confirm date,up to two years
Secondary	Adverse events	throughout study	evaluated in the two years since the treatment began according to the Common Terminology Criteria for Adverse Events Version 4.0