NSCLC
Conditions
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.
Interventions
DRUGApatinib
apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | evaluated in two years since the treatment began | Baseline to measured date of progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | tumor assessment every 8 weeks，up to two years | Baseline to measured stable disease |
| Disease control rate (DCR) | tumor assessment every 8 weeks，up to two years | Baseline to measured progressive disease |
| Overall survival (OS) | the first day of treatment to death or last survival confirm date，up to two years | Baseline to measured date of death from any cause |
| Adverse events | evaluated in the two years since the treatment began according to the Common Terminology Criteria for Adverse Events Version 4.0 | throughout study |
Countries
China
Contacts
Primary ContactJunfeng Liu, Professor
Backup ContactJunfeng Liu
Outcome results
None listed