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

NCT02733107 | Unknown Phase 2 DMC

• 1 other identifier: ACEL
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer; Apatinib; Etoposide

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  the first day of treatment to the date that disease progression is reported

  evaluated in 24 months since the treatment began

Secondary Outcomes (3)

• Objective Response Rate

  tumor assessment every 6-8 weeks since the treatment began，up to 24 months

• Overall survival

  the first day of treatment to death or last survival confirm date,up to 24 months

• Side effects

  evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Study Arms (1)

Apatinib+Etoposide

OTHER

Apatinib combined with Etoposide

Drug: Apatinib; Drug: Etoposide

Interventions

Apatinib DRUG

Apatinib, 250mg daily, po, continue until disease progression

Apatinib+Etoposide

Etoposide DRUG

Etoposide, 50mg daily, po, day 1 to day 20, repeat Q 4 weeks until disease progression

Also known as: VP-16

Apatinib+Etoposide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 26014294 BACKGROUND

• 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 in Japanese patients with previously treated non-small-cell lung cancer. J Thorac Oncol. 2015 Feb;10(2):346-52. doi: 10.1097/JTO.0000000000000395.

  PMID: 25299232 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

apatinib; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Xueqin Yang, PHD

CONTACT

86-23-68757151; yangxueqin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 11, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: April 12, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)