Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung

Summary

The main objective is to assess the efficacy of afatinib in combination with pembrolizumab, as measured by objective response (OR) in patients with locally advanced or metastatic squamous NSCLC who progressed during or after first line platinum-based treatment. The secondary objectives are to confirm the RP2D, assess the safety profile, and the secondary measures of clinical efficacy including disease control (DC), duration of objective response (DoR), progression-free survival (PFS), overall survival (OS), and tumour shrinkage.

Timeline

Start

2017-11-02

Primary completion

2020-01-13

Completion

2020-01-13

Publications

• Levy B, Barlesi F, Paz-Ares L, Bennouna J, Erman M, Felip E, Isla D, Ryun Kim H, Kim SW, Madelaine J, Molinier O, Ozguroglu M, Rodriguez Abreu D, Adeniji A, Lorence RM, Voccia I, Chisamore MJ, Riess JW. Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO). Lung Cancer. 2022 Apr;166:107-113. doi: 10.1016/j.lungcan.2022.01.023. Epub 2022 Feb 3.
• Levy B, Paz-Ares L, Bennouna J, Felip E, Abreu DR, Isla D, Barlesi F, Molinier O, Madelaine J, Audigier-Valette C, Kim SW, Kim HR, Ozguroglu M, Erman M, Badin FB, Mekhail TM, Scheff R, Chisamore MJ, Sadrolhefazi B, Riess JW. Afatinib With Pembrolizumab for Treatment of Patients With Locally Advanced/Metastatic Squamous Cell Carcinoma of the Lung: The LUX-Lung IO/KEYNOTE 497 Study Protocol. Clin Lung Cancer. 2019 May;20(3):e407-e412. doi: 10.1016/j.cllc.2018.12.022. Epub 2019 Jan 4.

Drugs

Indications