Anlotinib vs placebo as third- or further-line treatment for patients with small cell lung cancer: a randomised, double-blind, placebo-controlled Phase 2 study.

Abstract

BACKGROUND:

This study aimed to evaluate the efficacy and safety of anlotinib as a third-line and subsequent treatment for patients with small cell lung cancer (SCLC).

METHODS:

We conducted this Phase 2 trial at 11 institutions in China. Patients with pathologically confirmed SCLC who failed at least two lines of chemotherapy were enrolled. Subjects were randomly assigned in a 2:1 ratio to receive either anlotinib 12 mg orally once daily for 14 days every 3 weeks or placebo. The primary endpoint was progression-free survival (PFS).

RESULTS:

Between March 30, 2017 and June 8, 2018, a total of 82 and 38 patients were randomly assigned to receive anlotinib and placebo. The median PFS was significantly longer in the anlotinib group compared with the placebo group (4.1 months [95% confidence interval (CI), 2.8-4.2] vs 0.7 months [95% CI, 0.7-0.8]; hazard ratio (HR) 0.19 [95% CI, 0.12-0.32], p < 0.0001). Overall survival (OS) was significantly longer with anlotinib than placebo (7.3 months [95% CI, 6.1-10.3] vs 4.9 months [95% CI, 2.7-6.0]; HR 0.53 [95% CI, 0.34-0.81], p = 0.0029).

CONCLUSIONS:

Anlotinib as a third-line or subsequent treatment for Chinese patients with SCLC showed improved PFS and OS than placebo with favourable safety profile.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, number NCT03059797.

• Authors: Ying Cheng, Qiming Wang, Kai Li, Jianhua Shi, Ying Liu, Lin Wu, Baohui Han, Gongyan Chen, Jianxing He, Jie Wang, Donghua Lou, Hao Yu, Shanchun Wang, Haifeng Qin, Xiaoling Li
• Journal: British journal of cancer (Br J Cancer) Vol. 125 Issue 3 Pg. 366-371 (08 2021) ISSN: 1532-1827 [Electronic] England
• PMID: 34006926 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2021. The Author(s), under exclusive licence to Springer Nature Limited.

Chemical References

• Indoles
• Protein Kinase Inhibitors
• Quinolines
• anlotinib

Topics

• Administration, Oral
• Adult
• Aged
• China
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Indoles (administration & dosage, adverse effects)
• Lung Neoplasms (drug therapy)
• Male
• Middle Aged
• Protein Kinase Inhibitors (administration & dosage, adverse effects)
• Quinolines (administration & dosage, adverse effects)
• Small Cell Lung Carcinoma (drug therapy)
• Survival Analysis
• Treatment Outcome
• Young Adult