113P - Anlotinib as third-line treatment in patients with refractory advanced non-small cell lung cancer: A multicentre, randomized, double-blind, placebo-...

Date 17 April 2015
Event ELCC 2015
Session Poster lunch
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Baohui Han
Citation Annals of Oncology (2015) 26 (suppl_1): 29-44. 10.1093/annonc/mdv050
Authors B. Han1, K. Li2, Y. Zhao3, B. Li4, Y. Cheng5, J. Zhou6, Y. Lu7, Y. Shi8, Z. Wang9, L. Jiang1
  • 1Department Of Pulmonary, Shanghai Chest Hospital, 200030 - Shanghai/CN
  • 2Oncology Medicine, Tianjin Medical University Cancer Institute and Hospital, Tianjin/CN
  • 3Department Of Pulmonary, Shanghai Chest Hospital, Shanghai/CN
  • 4Department Of Oncology, Beijing Chest Hospital, Beijing/CN
  • 5Department Of Oncology, Jilin Province Cancer Hospital, Changchun/CN
  • 6Department Of Pulmonary, 1st Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou/CN
  • 7Department Of Oncology, West China Hospital, Huaxi, Sichuan University, Chengdu/CN
  • 8Department Of Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS), Beijing/CN
  • 9Department Of Oncology, Shandong Cancer Hospital, Jinan/CN



The aim of this randomised, double-blind, placebo-controlled, anlotinb study was to investigate its efficacy and safety in patients with refractory non-small-cell lung cancer.


Patients aged ≥18 years with histologically or cytological confirmed, metastatic or recurrent advanced non-squamous NSCLC and an ECOG performance status of 0–1 were randomised 1:1 to receive anlotinib or placebo (anlotinib 12mg/day, po, day 1-14 each 3-week) until progression or unacceptable toxicity, withdrawal of patient consent or death. Patients had received first and second line prior treatment for advanced NSCLC. The primary endpoint was PFS in the intent-to-treat (ITT) population; secondary endpoints included objective response rate (ORR), OS, exploratory biomarkers and safety.


Between 08, 2010 to 05, 2014, we enrolled 117 patients from 13 centres, 60 patients with anlotinib arm and 57 patients with placebo. Baseline characteristics were similar in both groups. PFS was prolonged with anlotinib 4.83 month versus placebo 1.23 months; HR 0.32(CI 0.20–0.51); p < 0.0001 (TTP population). ORR was anlotinib13.3% versus 0% with placebo (p < 0.006). Disease control rate was 93.3% with anlotinib versus 30% with placebo (p < 0.0001), respectively. OS data are not yet mature. Adverse events occurred more frequently with anlotinib (grade 1-2) than with placebo; Grade III/IV treatment-related adverse events increased 16.4% in anlotinib group. No grade 5 toxicities were recorded.


This study confirms that anlotinib as the third line agent has significant PFS benefit in Chinese patients with refractory advanced NSCLC compared to placebo. No serious safety concerns were reported in the study.

Clinical trial identification NCT01924195. Release date 12 Aug 2013


All other authors have declared no conflicts of interest.