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Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

apatinib

placebo

About this trial

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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients 18 to 70 years of age
Documented pathological evidence of advanced non-squamous non-small cell lung cancer with measurable lesions
Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and second-line or more regimens of chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1
Patients had to have recovered from any toxic effects of therapy
Patients with brain/meninges metastasis should keep stable disease for 2 months before randomisation
Adequate hematologic and biochemical values were required

Exclusion Criteria:

Presence of small-cell lung cancer alone or with NSCLC
Pregnant or breast-feeding women
Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure > 140 mmHg，diastolic pressure > 90 mmHg), cardiac ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac insufficiency
Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction)
Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy
≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks
Bone fracture or wounds that was not cured for a long time
Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents
Mental diseases and psychotropic substances abuse
Previous treatment with an experimental agent within 4 weeks
Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS
Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in situ of uterine cervix)

Sites / Locations

Cancer Center of Sun Yat-Sen University (CCSU)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apatinib

Placebo

Arm Description

750 mg，po，QD； 28 days every cycle

Outcomes

Primary Outcome Measures

Progression free survival (PFS)

Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.

Secondary Outcome Measures

Objective Response Rate(ORR)

ORR was the percentage of patients who got partial or complete response

Overall Survival(OS)

OS was determined from date of enrollment until death or the date the patient was recorded alive of last follow-up

Toxicity

Adverse events (AEs) were recorded, graded for toxicity using the NCI-CTC, and assessed by the investigator for any relationship with treatment.

Full Information

NCT ID

NCT01287962

First Posted

January 31, 2011

Last Updated

December 5, 2013

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01287962

Brief Title

Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

Official Title

Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer:a Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

April 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous 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

Apatinib, Non-small Cell Lung Cancer, VEGFR TKIs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib

Arm Type

Experimental

Arm Description

750 mg，po，QD； 28 days every cycle

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

apatinib

Intervention Description

750 mg，po，QD； 28 days every cycle

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

po，QD； 28 days every cycle

Primary Outcome Measure Information:

Title

Progression free survival (PFS)

Description

Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Objective Response Rate(ORR)

Description

ORR was the percentage of patients who got partial or complete response

Time Frame

24 months

Title

Overall Survival(OS)

Description

OS was determined from date of enrollment until death or the date the patient was recorded alive of last follow-up

Time Frame

24 months

Title

Toxicity

Description

Adverse events (AEs) were recorded, graded for toxicity using the NCI-CTC, and assessed by the investigator for any relationship with treatment.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients 18 to 70 years of age Documented pathological evidence of advanced non-squamous non-small cell lung cancer with measurable lesions Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and second-line or more regimens of chemotherapy Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1 Patients had to have recovered from any toxic effects of therapy Patients with brain/meninges metastasis should keep stable disease for 2 months before randomisation Adequate hematologic and biochemical values were required Exclusion Criteria: Presence of small-cell lung cancer alone or with NSCLC Pregnant or breast-feeding women Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure > 140 mmHg，diastolic pressure > 90 mmHg), cardiac ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac insufficiency Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction) Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy ≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks Bone fracture or wounds that was not cured for a long time Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents Mental diseases and psychotropic substances abuse Previous treatment with an experimental agent within 4 weeks Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in situ of uterine cervix)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Zhang, MD

Organizational Affiliation

Cancer Center of Sun Yat-Sen University (CCSU)

Official's Role

Study Chair

Facility Information:

Facility Name

Cancer Center of Sun Yat-Sen University (CCSU)

City

Guangzhou

State/Province

Guangdong

Country

China

12. IPD Sharing Statement

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Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

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