Clinical trial NCT03634059: A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations
Official title: A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NSCLC
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression free survival
timeFrame: evaluated in two years since the treatment began
Secondary outcomes:
measure: Objective response rate
timeFrame: tumor assessment every 8 weeks，up to two years
measure: Disease control rate (DCR)
timeFrame: tumor assessment every 8 weeks，up to two years
measure: Overall survival (OS)
timeFrame: the first day of treatment to death or last survival confirm date，up to two years
measure: Adverse events
timeFrame: evaluated in the two years since the treatment began according to the Common Terminology Criteria for Adverse Events Version 4.0
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Junfeng Liu
state: Hebei
Study officials:
affiliation: Hebei Medical University Fourth Hospital
name: Junfeng Liu
role: PRINCIPAL_INVESTIGATOR
References: