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An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer (EASE)

Primary Purpose

Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib Mesylate tablet combined with S-1 capsules

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell lung cancer, Apatinib, S1

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically confirmed Non-small cell lung cancer
Patients with extracranial measurable lesions
Patients with NSCLC failed for standard treatments
Eastern Cooperative Oncology Group performance status score: 0~2 and life expectancy of more than 3 months
Major organs functioning properly
Compliance is good and agreed to cooperate with the survival of follow-up
Informed consent

Exclusion Criteria:

Contraindications for investigational agents
Patients with clinical symptoms of brain metastases or meningeal metastasis
Tumor invade big vessels or close to big vessels
Uncontrolled hypertension
Abnormal coagulation (INR>1.5 or Prothrombin Time>ULN+4, or Activated Partial Thromboplastin Time>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.
Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
Received big surgery, had bone fracture or ulcer in 4 weeks.
Urine protein≥++, or urine protein in 24 hours≥1.0g

Sites / Locations

Changzhou Cancer Hospital of Soochow University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib & S-1

Arm Description

Apatinib Mesylate tablet combined with S-1 Capsules Apatinib Mesylate tablet 250mg once daily combined with S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules) 40mg~60mg twice daily by mouth, d1-14, repeated every 3 weeks.

Outcomes

Primary Outcome Measures

Progression Free Survival(PFS)

PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

Secondary Outcome Measures

Overall Survival(OS)

Overall Survival is defined as the length of time from random assignment to death or to last contact.

Objective response rate(ORR)

Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）

Disease Control Rate(DCR)

Disease Control Rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease according to radiological assessments.

Adverse Events(AEs)

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

Full Information

NCT ID

NCT03129256

First Posted

April 17, 2017

Last Updated

December 9, 2019

Sponsor

Changzhou Cancer Hospital of Soochow University

1. Study Identification

Unique Protocol Identification Number

NCT03129256

Brief Title

An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer

Acronym

EASE

Official Title

An Exploratory Study of Low-dose Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

December 30, 2018 (Actual)

Study Completion Date

December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Changzhou Cancer Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is to explore the potential efficacy and safety of low-dose Apatinib combined with S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with oral apatinib and S-1 after treatment failure of standard regimen.

Detailed Description

Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). The anti-angiogenesis effect of apatinib has been proved in preclinical tests. Phase II study has showed an improvement of progression free survival in pretreated patients. S-1, an oral fluoropyrimidine has considerable effectiveness with mild side effect in patients failed to standard treatments. The purpose of this study is to evaluate the potential efficacy and safety of low-dose Apatinib combined with S-1 in heavily pretreated patients with advanced lung cancer. And to explore the biomarkers of antiangiogenesis therapy and the possible mechanisms of treatment resistance on the basis of next generation sequencing.

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, S1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apatinib & S-1

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Apatinib Mesylate tablet combined with S-1 capsules

Other Intervention Name(s)

Ai Tan combined with S-1, Apatinib combined with S-1

Intervention Description

Oral use with low-dose Apatinib combined with S-1 until disease progression

Primary Outcome Measure Information:

Title

Progression Free Survival(PFS)

Description

PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall Survival(OS)

Description

Overall Survival is defined as the length of time from random assignment to death or to last contact.

Time Frame

2 years

Title

Objective response rate(ORR)

Description

Time Frame

2 years

Title

Disease Control Rate(DCR)

Description

Disease Control Rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease according to radiological assessments.

Time Frame

2 years

Title

Adverse Events(AEs)

Description

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed Non-small cell lung cancer Patients with extracranial measurable lesions Patients with NSCLC failed for standard treatments Eastern Cooperative Oncology Group performance status score: 0~2 and life expectancy of more than 3 months Major organs functioning properly Compliance is good and agreed to cooperate with the survival of follow-up Informed consent Exclusion Criteria: Contraindications for investigational agents Patients with clinical symptoms of brain metastases or meningeal metastasis Tumor invade big vessels or close to big vessels Uncontrolled hypertension Abnormal coagulation (INR>1.5 or Prothrombin Time>ULN+4, or Activated Partial Thromboplastin Time>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. Myocardial ischemia or infarction more than stage II, cardiac insufficiency. Received big surgery, had bone fracture or ulcer in 4 weeks. Urine protein≥++, or urine protein in 24 hours≥1.0g

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tong Zhou, Dr.

Organizational Affiliation

Changzhou Cancer Hospital of Soochow University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changzhou Cancer Hospital of Soochow University

City

Changzhou

State/Province

Jiangsu

ZIP/Postal Code

213000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer

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