The Efficacy and Safety of Apatinib Combined With Etoposide in Heavily Pretreated Advanced Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

The Efficacy and Safety of Apatinib Combined With Etoposide in Advanced Non-small Cell Lung Cancer Patients Failed to Previous at Least 2rd Line Treatments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02733107
• Other study ID #: ACEL
• Status: Recruiting
• Phase: Phase 2
• First received: April 5, 2016
• Last updated: April 10, 2016
• Start date: March 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2016
• Source: Third Military Medical University
• Contact: Xueqin Yang, PHD
• Phone: 86-23-68757151
• Email: yangxueqin[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung cancer which is recommended by NCCN guideline. The investigators wondered whether these two drugs have synergistic effects when treating advanced non-small cell lung cancer patients who failed to previous at least 2nd line treatments. Thus, the aim of this trial is to investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated advanced non-small cell lung cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Obtain of informed consent.

• Histologically or cytologically confirmed non-small cell lung cancer.

• World Health Organization (WHO) performance status (PS) of 0 to 2.

• Measurable lesions as defined by RECIST criteria.

• Second-line or more treatments.

• Wild type of epidermal-growth-factor receptor (EGFR).

• Life expectancy =12 weeks.

• Organ functions normal, as defined below, within two weeks of randomization:

• Hb=90g/L Absolute neutrophils count(ANC)=1.5×109/L Platelets=80×109/L Serum bilirubin=2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT)=2.5×ULN(=5×ULN if liver metastases) Creatinine clearance=45ml/min or Cr=1.25×ULN.

• Females of child-bearing potential must have negative serum pregnancy test.

• Sexually active males and females (of childbearing potential) willing to practice contraception during the study.

Exclusion Criteria:

• Small cell lung cancer.

• Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.

• Uncontrolled hypertension.

• Myocardial ischemia or infarction more than stage II, cardiac insufficiency.

• Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy.

• Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).

• Hemoptysis, more than 2.5ml daily.

• Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.

• Unhealed bone fracture or wound for long time.

• Received big surgery, had bone fracture or ulcer in 4 weeks.

• Urine protein=++, or urine protein in 24 hours=1.0g.

• Pregnant or lactating woman.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Apatinib
Apatinib, 250mg daily, po, continue until disease progression
• Etoposide
Etoposide, 50mg daily, po, day 1 to day 20, repeat Q 4 weeks until disease progression

Locations

Country	Name	City	State
China	Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Okamoto I, Miyazaki M, Takeda M, Terashima M, Azuma K, Hayashi H, Kaneda H, Kurata T, Tsurutani J, Seto T, Hirai F, Konishi K, Sarashina A, Yagi N, Kaiser R, Nakagawa K. Tolerability of nintedanib (BIBF 1120) in combination with docetaxel: a phase 1 study — View Citation

Zhou C, Wu YL, Chen G, Liu X, Zhu Y, Lu S, Feng J, He J, Han B, Wang J, Jiang G, Hu C, Zhang H, Cheng G, Song X, Lu Y, Pan H, Zheng W, Yin AY. BEYOND: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of First-Line Carboplatin/Paclitaxel Plus Bevacizumab or Placebo in Chinese Patients With Advanced or Recurrent Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Jul 1;33(19):2197-204. doi: 10.1200/JCO.2014.59.4424. Epub 2015 May 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	the first day of treatment to the date that disease progression is reported	evaluated in 24 months since the treatment began	No
Secondary	Objective Response Rate	the ratio between the number of responders and number of patients assessable for tumor response	tumor assessment every 6-8 weeks since the treatment began,up to 24 months	No
Secondary	Overall survival		the first day of treatment to death or last survival confirm date,up to 24 months	No
Secondary	Side effects		evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Yes