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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Apatinib; Drug: Etoposide

• Registration Number: NCT02733107
• Lead Sponsor: Third Military Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-04
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-08
• Last Update Submitted: 2016-04-10
• Study First Posted: 2016-04-11
• Last Update Posted: 2016-04-12
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib+Etoposide	Apatinib	Apatinib combined with Etoposide
Apatinib+Etoposide	Etoposide	Apatinib combined with Etoposide

Primary Outcome Measures

Name	Time	Method
Progression free survival	evaluated in 24 months since the treatment began	the first day of treatment to the date that disease progression is reported

Secondary Outcome Measures

Name	Time	Method
Side effects	evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Overall survival	the first day of treatment to death or last survival confirm date,up to 24 months
Objective Response Rate	tumor assessment every 6-8 weeks since the treatment began，up to 24 months	the ratio between the number of responders and number of patients assessable for tumor response

Trial Locations

Locations (1)

Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China