Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

Summary

Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged by investigator).

Timeline

Start

2013-09-30

Primary completion

2018-07-06

Completion

2018-07-06

Publications

• Zhao J, Bai H, Wang X, Wang Y, Duan J, Chen H, Xue Z, Tian Y, Cseh A, Huang DC, Wu YL, Wang J. Biomarker subset analysis of a phase IIIb, open-label study of afatinib in EGFR tyrosine kinase inhibitor-naive patients with EGFRm+ non-small-cell lung cancer. Future Oncol. 2022 Apr;18(12):1485-1497. doi: 10.2217/fon-2021-0394. Epub 2022 Feb 4.
• Tu HY, Feng J, Shi M, Zhao J, Wang Y, Chang J, Wang J, Cheng Y, Zhu J, Tan EH, Li K, Zhang Y, Lee V, Yang CT, Su WC, Lam DC, Srinivasa BJ, Rajappa S, Ho CL, Lam KC, Hu Y, Bondarde SA, Liu X, Tian Y, Xue Z, Cseh A, Huang DC, Zhou C, Wu YL. A Phase IIIb Open-Label, Single-Arm Study of Afatinib in EGFR TKI-Naive Patients with EGFRm+ NSCLC: Final Analysis, with a Focus on Patients Enrolled at Sites in China. Target Oncol. 2022 Jan;17(1):1-13. doi: 10.1007/s11523-021-00859-6. Epub 2022 Jan 12.

Drugs

Indications