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

Non-small Cell Lung Cancer Clinical Trial

— EASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129256
• Other study ID #: CCH001
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: December 2019
• Source: Changzhou Cancer Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Apatinib Mesylate tablet combined with S-1 capsules
Oral use with low-dose Apatinib combined with S-1 until disease progression

Locations

Country	Name	City	State
China	Changzhou Cancer Hospital of Soochow University	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Changzhou Cancer Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	Overall Survival(OS)	Overall Survival is defined as the length of time from random assignment to death or to last contact.	2 years
Secondary	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)	2 years
Secondary	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.	2 years
Secondary	Adverse Events(AEs)	AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.	2 years