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

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

Etoposide

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer, Apatinib, Etoposide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Daping Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Apatinib+Etoposide

Arm Description

Apatinib combined with Etoposide

Outcomes

Primary Outcome Measures

Progression free survival

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

Secondary Outcome Measures

Objective Response Rate

the ratio between the number of responders and number of patients assessable for tumor response

Overall survival

Side effects

Full Information

NCT ID

NCT02733107

First Posted

April 5, 2016

Last Updated

April 10, 2016

Sponsor

Third Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02733107

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Military Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer, Apatinib, Etoposide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib+Etoposide

Arm Type

Other

Arm Description

Apatinib combined with Etoposide

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

VP-16

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression free survival

Description

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

Time Frame

evaluated in 24 months since the treatment began

Secondary Outcome Measure Information:

Title

Objective Response Rate

Description

the ratio between the number of responders and number of patients assessable for tumor response

Time Frame

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

Title

Overall survival

Time Frame

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

Title

Side effects

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xueqin Yang, PHD

Phone

86-23-68757151

yangxueqin@hotmail.com

Facility Information:

Facility Name

Daping Hospital, Third Military Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xueqin Yang, PH.D.

Phone

86-23-68757151

yangxueqin@hotmail.com

First Name & Middle Initial & Last Name & Degree

Xueqin Yang, PH.D.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26014294

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.

Results Reference

background

PubMed Identifier

25299232

Citation

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.

Results Reference

result

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

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