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Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer:a Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer:a Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study


Inclusion Criteria:



1. Patients 18 to 70 years of age

2. Documented pathological evidence of advanced non-squamous non-small cell lung cancer
with measurable lesions

3. Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and
second-line or more regimens of chemotherapy

4. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1

5. Patients had to have recovered from any toxic effects of therapy

6. Patients with brain/meninges metastasis should keep stable disease for 2 months
before randomisation

7. Adequate hematologic and biochemical values were required

Exclusion Criteria:

1. Presence of small-cell lung cancer alone or with NSCLC

2. Pregnant or breast-feeding women

3. Severe or uncontrolled systemic disease such as clinically significant
hypertension(systolic pressure > 140 mmHg,diastolic pressure > 90 mmHg), cardiac
ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac
insufficiency

4. Difficulties in taking pills (inability to swallow tablets,GI tract resection,
chronic bacillary diarrhea and intestinal obstruction)

5. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy

6. ≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks

7. Bone fracture or wounds that was not cured for a long time

8. Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents

9. Mental diseases and psychotropic substances abuse

10. Previous treatment with an experimental agent within 4 weeks

11. Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS

12. Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in
situ of uterine cervix)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Description:

Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Li Zhang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Center of Sun Yat-Sen University (CCSU)

Authority:

China: Food and Drug Administration

Study ID:

HENGRUI 20110301

NCT ID:

NCT01287962

Start Date:

April 2011

Completion Date:

April 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Apatinib
  • Non-small Cell Lung Cancer
  • VEGFR TKIs
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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