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

NCT ID: NCT03634059

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2020-08-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

apatinib

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

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

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

Interventions

Apatinib

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

Intervention Type: DRUG

Eligibility Criteria

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 ⅢB - 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

LiuJunFeng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junfeng Liu

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Locations

Junfeng Liu

Shijiazhuang, Hebei, China

Countries

China

Central Contacts

Junfeng Liu, Professor

Role: CONTACT

13931152296@126.com

13931152296

Junfeng Liu

Role: CONTACT

13931152296@126.com

13931152296

Facility Contacts

Junfeng Liu, Professor

Role: primary

13931152296@126.com

13931152296

Other Identifiers

HRA-L01

Identifier Type: -

Identifier Source: org_study_id