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

Changzhou Cancer Hospital of Soochow University

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Apatinib Mesylate tablet combined with S-1 capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT03129256

CCH001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Apatinib & S-1

Experimental group

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.

Treatment:

Drug: Apatinib Mesylate tablet combined with S-1 capsules