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

• Sponsor: Changzhou Cancer Hospital of Soochow University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03129256
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arm: 1
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Apatinib Mesylate tablet combined with S-1 capsules	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory Study of Low-dose Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Apatinib & S-1 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.	Drug: Apatinib Mesylate tablet combined with S-1 capsules; Oral use with low-dose Apatinib combined with S-1 until disease progression; Other Names: Ai Tan combined with S-1 Apatinib combined with S-1

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival(PFS) [2 years]

   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

1. Overall Survival(OS) [2 years]

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

2. Objective response rate(ORR) [2 years]

   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）

3. Disease Control Rate(DCR) [2 years]

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

4. Adverse Events(AEs) [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changzhou Cancer Hospital of Soochow University	Changzhou	Jiangsu	China	213000

Sponsors and Collaborators

• Changzhou Cancer Hospital of Soochow University

Investigators

• Principal Investigator: Tong Zhou, Dr., Changzhou Cancer Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Changzhou Cancer Hospital of Soochow University
• ClinicalTrials.gov Identifier: NCT03129256
• Other Study ID Numbers: CCH001
• First Posted: Apr 26, 2017
• Last Update Posted: Dec 10, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Changzhou Cancer Hospital of Soochow University: non-small cell lung cancer; Apatinib; S1
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Apatinib

Study Results

No Results Posted as of Dec 10, 2019