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Clinical Study

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.

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Acknowledgements

We thank the patients and their families, all the investigators and the study personnel involved in the study.

Author information

Authors and Affiliations

Authors

Contributions

Y.C., Y.L. and S.W. designed the study. Y.C., D.L. and H.Y. analysed the data. Y.C., Q.W., K.L., J.S., Y.L., L.W., B.H., G.C., J.H., J.W., D.L., H.Y., H.Q. and X.L. contributed to data collection, data interpretation, and writing of the report. All authors reviewed and approved the article to be submitted.

Corresponding author

Correspondence to Ying Cheng.

Ethics declarations

Ethics approval and consent to participate

The study was performed in accordance with the Declaration of Helsinki and Guidelines for Good Clinical Practice, as well as laws and regulations in China. The study protocol was approved by the institutional review board in each participating institution. All patients provided written informed consent before any study-related procedure.

Data availability

The data used and analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

S.W. is a senior engineer of Chia-tai Tianqing Pharmaceutical Group Co., Ltd. All the other authors declare no conflict of interests.

Funding information

This work was supported by Chia-tai Tianqing Pharmaceutical Group Co., Ltd. The funder had no role in the design the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication. The funder provided the study drug. This paper is supported by the Special Project for Significant New Drug Research and Development in the Major National Science and Technology Projects of China (project no. 2020ZX09201-024).

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Cheng, Y., Wang, Q., Li, K. et al. 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. Br J Cancer 125, 366–371 (2021). https://doi.org/10.1038/s41416-021-01356-3

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