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

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.

Study Overview

• Status: Unknown
• Conditions: NSCLC
• Intervention / Treatment: Drug: Apatinib

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junfeng Liu, Professor; Phone Number: 13931152296; Email: 13931152296@126.com
• Study Contact Backup: Name: Junfeng Liu; Phone Number: 13931152296; Email: 13931152296@126.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Junfeng Liu
      • Contact: Junfeng Liu, Professor; Phone Number: 13931152296; Email: 13931152296@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: apatinib; apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po	Drug: Apatinib; apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Baseline to measured date of progression or death from any cause	evaluated in two years since the treatment began

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital
• Investigators: Principal Investigator: Junfeng Liu, Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2018
• Primary Completion (Anticipated): August 15, 2019
• Study Completion (Anticipated): August 15, 2020

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: HRA-L01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No