Anlotinib Combined With Docetaxel Versus Docetaxel for Previous Treated Advanced NSCLC

Summary

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase Ⅲ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib（12mg，po. qd. on day 1to14 of a 21-day cycle） or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. Therefore,we envisage using anlotinib plus docetaxel treat the EGFR wild-type advanced Non-small cell lung cancer patients who were failure in the treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS.

Timeline

Start

2018-12-21

Primary completion

2019-11-01

Completion

2020-11-01

Publications

• Shou J, Chen J, Guo Q, Hong W, Wang Y, Rao C, Lu L, Yang X, Zhu D, Lan F, Fang Y, Pan H. Anlotinib in combination with docetaxel for advanced nonsmall cell lung cancer after failure of platinum-based treatment: A phase 1/2 trial. Cancer. 2025 May 15;131(10):e35822. doi: 10.1002/cncr.35822.
• Pu X, Shou J, Xiao Z, Chen J, Xiao M, Guo Q, Ma Z, Hong W, Wang Q, Wang Y, Li J, Rao C, Weng J, Lu L, Wu L, Fang Y. Anlotinib Plus Docetaxel is Promising in Advanced NSCLC Progressing on First-Line Immunotherapy: A Pooled Analysis of Two Randomized Trials. Adv Ther. 2025 Jul;42(7):3249-3264. doi: 10.1007/s12325-025-03170-2. Epub 2025 May 12.

Drugs

Indications