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

Not Applicable

• Conditions: NSCLC
• Interventions: Drug: Apatinib

• Registration Number: NCT03634059
• Lead Sponsor: Hebei Medical University Fourth Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-08-14
• Last Update Submitted: 2018-08-14
• Study Start: 2018-08-15
• Study First Posted: 2018-08-16
• Last Update Posted: 2018-08-16
• Primary Completion: 2019-08-15
• Study Completion: 2020-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
apatinib	Apatinib	apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po

Primary Outcome Measures

Name	Time	Method
Progression free survival	evaluated in two years since the treatment began	Baseline to measured date of progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
Objective response rate	tumor assessment every 8 weeks，up to two years	Baseline to measured stable disease
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
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
Disease control rate (DCR)	tumor assessment every 8 weeks，up to two years	Baseline to measured progressive disease

Trial Locations

Locations (1)

Junfeng Liu; 🇨🇳 Shijiazhuang, Hebei, China