Apatinib for Extensive Stage Small Cell Lung Cancer After Second/Third Line Chemotherapy.
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and
      etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive
      small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is
      no standard treatment recommendation for this group of patients who failed to second-line
      therapy and had good performance status. Apatinib has been approved as a second-line
      treatment for advanced gastric cancer. Several phase III clinical studies of non small cell
      lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less
      toxic side effects and better patient tolerance. However, the clinical application of
      apatinib in small cell lung cancer is still lack of evidence-based medicine. And this
      clinical trial is designed to prospectively investigate the efficacy and safety of apatinib
      in refractory or recurrent ED-SCLC patients in our center.
    

Detailed description: 
      Small cell lung cancer (SCLC) is a highly aggressive disease characterized by its rapid
      doubling time, high growth fraction, early development of disseminated disease, and dramatic
      response to first-line chemotherapy and radiation. Small cell lung cancer accounts for
      approximately 20%-25% lung cancer patients. SCLC patients are categorized as limited disease,
      defined as disease that is confined to the ipsilateral hemithorax that can be encompassed
      within a tolerable radiation port, or extensive disease (ED), defined as the presence of
      overt metastatic disease determined by imaging or physical examination. Two third of patients
      are diagnosed with ED at presentation. Despite the development of novel cytotoxic drugs, the
      therapeutic approach to SCLC has been stagnant for more than twenty years. Standard treatment
      for ED-SCLC remains EP or CE, a regimen that yield a median survival of approximately 9
      months and a 5-year survival of less than 1%.In some guidelines for SCLC, topotecan is
      recommended as the standard second-line treatment in patients who relapse less than 3 months.
      As for patients who relapse more than six months after the end of initial treatment, EP or CE
      regimen is recommended to be used again.There is no standard treatment recommendation for
      this group of patients who failed to second-line therapy.Apatinib has been approved as a
      second-line treatment for advanced gastric cancer. Several phase III clinical studies of non
      small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib
      has less toxic side effects and better patient tolerance.And this clinical trial is designed
      to prospectively investigate the efficacy and safety of apatinib in refractory or recurrent
      ED-SCLC patients.
    

Intervention name(s): apatinib
Intervention type(s): Drug
Intervention description(s): apatinib 500mg/d until progressive Disease
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment