Clinical trial NCT03129256: An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
Apatinib
S1
Lead sponsor: Changzhou Cancer Hospital of Soochow University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: 2 years
measure: Objective response rate(ORR)
timeFrame: 2 years
measure: Disease Control Rate(DCR)
timeFrame: 2 years
measure: Adverse Events(AEs)
timeFrame: 2 years
Other outcomes:
Locations:
city: Changzhou
country: China
facility: Changzhou Cancer Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Changzhou Cancer Hospital of Soochow University
name: Tong Zhou, Dr.
role: PRINCIPAL_INVESTIGATOR
References: