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The Efficacy and Safety of Apatinib in Heavily Pretreated Advanced Non-squamous 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 single agent

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring apatinib, NSCLC, safety, efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Obtain of informed consent.
Aged 18 years and over.
Histologically or cytologically confirmed non-squamous non-small cell lung cancer.
World Health Organization (WHO) performance status (PS) of 0 to 2.
Measurable lesions as defined by RECIST criteria.
Life expectancy ≥12 weeks.
Progressed after at least two lines systemic treatment, or were not amendable to receive the current standard therapy

7. 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 8. 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:

Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
Tumor invade big vessels or close to big vessels (less than 5mm)
Obvious cavity or necrosis formed in the tumor
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
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

Department of Oncology, Shanghai pulmonary hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

apatinib single agent

Arm Description

apatinib, single agent, 500mg or 750mg Qd po, continue until disease progression

Outcomes

Primary Outcome Measures

Objective Response Rate

To evaluate Objective response rate every 6-8 weeks after the initiation of apatinib.

Secondary Outcome Measures

Progression free survival

PFS is evaluated in 24 months since the treatment began

Full Information

NCT ID

NCT02515435

First Posted

July 30, 2015

Last Updated

August 15, 2017

Sponsor

Tongji University

1. Study Identification

Unique Protocol Identification Number

NCT02515435

Brief Title

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

Official Title

Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Apatinib as a Single Agent in Advanced NSCLC Who Failed to at Least Two Lines Systemic Treatment, or Were Not Amendable to Receive the Second-line Standard Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2015 (undefined)

Primary Completion Date

August 1, 2016 (Actual)

Study Completion Date

December 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tongji 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, also known as YN968D1, is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2) and also represents mild inhibition to PDGFR, c-Kit and c-src tyrosine kinases. It is an orally bioavailable, small molecule agent which is thought to inhibit VEGF-mediated endothelial cell migration and proliferation thus blocking blood vessel formation in tumor tissues. Previous studies have identified that apatinib was well tolerated at doses below 750mg daily. In phase I/II study, investigators reported an objective response rate of 68%. In a phase III trial conducted in advanced pretreated gastric cancer, the median overall survival was significantly prolonged in the apatinib group compared with placebo group. Thus, in this trial, the investigators aim to investigate the efficacy and safety of apatinib in previously treated advanced non-squamous non-small cell lung cancer.

Detailed Description

Observing the efficacy and safety of apatinib in heavily treated non-squamous non-small cell lung cancer. Primary Outcome Measure: Objective Response Rate Secondary Outcome Measures: Progression free survival, overall survival, Side effects, Quality Of Life

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, NSCLC, safety, efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

apatinib single agent

Arm Type

Experimental

Arm Description

apatinib, single agent, 500mg or 750mg Qd po, continue until disease progression

Intervention Type

Drug

Intervention Name(s)

apatinib single agent

Other Intervention Name(s)

YN968D1

Intervention Description

For those heavily treated non-squamous non-small cell lung cancer, treat with apatinib single agent, 500mg or 750mg Qd, p.o based on the status of patient, continue until disease progression, dose reduction was admitted

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

To evaluate Objective response rate every 6-8 weeks after the initiation of apatinib.

Time Frame

tumor assessment every 2 cycles after the initiation of apatinib，up to 24 months

Secondary Outcome Measure Information:

Title

Progression free survival

Description

PFS is evaluated in 24 months since the treatment began

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Overall survival

Description

evaluated in the 24th month since the treatment began

Time Frame

12 months

Title

side effects

Description

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

Time Frame

12 months

Title

Quality of life

Description

evaluated in the 24th month since the treatment began

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Obtain of informed consent. Aged 18 years and over. Histologically or cytologically confirmed non-squamous non-small cell lung cancer. World Health Organization (WHO) performance status (PS) of 0 to 2. Measurable lesions as defined by RECIST criteria. Life expectancy ≥12 weeks. Progressed after at least two lines systemic treatment, or were not amendable to receive the current standard therapy 7. 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 8. 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: Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation. Tumor invade big vessels or close to big vessels (less than 5mm) Obvious cavity or necrosis formed in the tumor 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

caicun zhou, MD,PhD

Organizational Affiliation

Shanghai Pulmonary Hospital, Tongji University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, Shanghai pulmonary hospital

City

Shanghai

ZIP/Postal Code

200433

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

30026059

Citation

Wu F, Zhang S, Xiong A, Gao G, Li W, Cai W, Su C, Chen X, Zhou F, Zhao J, Ren S, Zhou C. A Phase II Clinical Trial of Apatinib in Pretreated Advanced Non-squamous Non-small-cell Lung Cancer. Clin Lung Cancer. 2018 Nov;19(6):e831-e842. doi: 10.1016/j.cllc.2018.06.002. Epub 2018 Jun 27.

Results Reference

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

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