Gefitinib in Combination With Anlotinib or Placebo in Previously Untreated EGFR-mutant NSCLC

Summary

Gefitinib is currently the standard-of-care for patients with activating-EGFR mutant advanced non-small cell lung cancer (NSCLC). However, \~30-40% patients are still nonresponsive, and experience significantly varying duration of response and survival rate. Anlotinib is an efficient multi-target tyrosine kinase inhibitor (TKI) that effectively block the migration and proliferation of endothelial cells and reduce tumor microvascular density by targeting VEGFRs, FGFRs, PDGFRs. It has been proved to be safe and effective in advanced lung cancer after second-line standard chemotherapy failure, which can significantly extend the survival of patients and approves as a third-line treatment for advanced NSCLC. Here, we prepared to evaluate whether the combination of gefitinb and anlotinib can preferably improved survival of untreated NSCLC with EGFR activating mutation.

Timeline

Start

2019-04-10

Primary completion

2020-12

Completion

2022-12

Publications

• Zhou HQ, Zhang YX, Chen G, Yu QT, Zhang H, Wu GW, Wu D, Lin YC, Zhu JF, Chen JH, Hu XH, Lan B, Zhou ZQ, Lin HF, Wang ZB, Lei XL, Pan SM, Chen LM, Zhang J, Kong TD, Yao JC, Zheng X, Li F, Zhang L, Fang WF. Gefitinib (an EGFR tyrosine kinase inhibitor) plus anlotinib (an multikinase inhibitor) for untreated, EGFR-mutated, advanced non-small cell lung cancer (FL-ALTER): a multicenter phase III trial. Signal Transduct Target Ther. 2024 Aug 13;9(1):215. doi: 10.1038/s41392-024-01927-9.

Drugs

Indications