OBJECTIVES: Anlotinib is a novel multi-target tyrosine Kinase inhibitor that 
inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret. In the phase III 
ALTER-0303 trial (Clinical Trial Registry ID: NCT 02388919), anlotinib 
significantly improved overall survival versus placebo in advanced 
non-small-cell lung cancer (NSCLC) patients who had received at least two 
previous chemotherapy and epidermal growth factor receptor/anaplastic lymphoma 
kinase targeted therapy regimens. This study assessed quality of life (QoL) in 
these patients.
METHODS: Patients were randomized (2:1) to anlotinib or placebo up to 
progression or intolerable toxicity. The QoL were assessed using the European 
Organization for Research and Treatment of Cancer (EORTC) Quality of Life 
Questionnaire Core 30 (QLQ-C30) and the associated EORTC Quality of Life Lung 
Cancer Specific Module (QLQ-LC13) at baseline, end of cycle 1, end of every two 
cycles, and at the final visit. The analyses were conducted in the first 6 
cycles. Differences in scores of 10 points or more between two arms or from 
baseline were considered clinically meaningful.
RESULTS: A total of 437 patients were assigned to anlotinib (n = 294) and 
placebo (n = 143). The completion rates of the QoL questionnaires were from 
69.9% to 97.0%. Mean scores of QLQ-C30 and QLQ-LC13 subscales were similar in 
the anlotinib and placebo arms at baseline. Compared to placebo, anlotinib 
improved role functioning, social functioning, dyspnea, insomnia, constipation 
and financial problems. Only sore mouth or tongue symptom was worse in the 
anlotinib arm than in the placebo arm.
CONCLUSIONS: Anlotinib improved quality of life versus placebo in advanced NSCLC 
patients who had received at least two previous chemotherapies. The QoL analyses 
provided evidence that anlotinib should be a choice for the third-line treatment 
or beyond in advanced NSCLC.