A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

Summary

This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

Timeline

Start

2019-09-19

Primary completion

2023-05-11

Completion

2026-12-31

Publications

• Background F Smit E, Dooms C, Raskin J, Nadal E, Tho LM, Le X, Mazieres J, S Hin H, Morise M, W Zhu V, Tan D, H Holmberg K, Ellers-Lenz B, Adrian S, Brutlach S, Schumacher KM, Karachaliou N, Wu YL. INSIGHT 2: a phase II study of tepotinib plus osimertinib in MET-amplified NSCLC and first-line osimertinib resistance. Future Oncol. 2022 Mar;18(9):1039-1054. doi: 10.2217/fon-2021-1406. Epub 2021 Dec 17.
• Wu YL, Guarneri V, Voon PJ, Lim BK, Yang JJ, Wislez M, Huang C, Liam CK, Mazieres J, Tho LM, Hayashi H, Nhung NV, Chia PL, de Marinis F, Raskin J, Zhou Q, Finocchiaro G, Le AT, Wang J, Dooms C, Kato T, Nadal E, Hin HS, Smit EF, Wermke M, Tan D, Morise M, O'Brate A, Adrian S, Pfeiffer BM, Stroh C, Juraeva D, Strotmann R, Goteti K, Berghoff K, Ellers-Lenz B, Karachaliou N, Le X, Kim TM; INSIGHT 2 investigators. Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2024 Aug;25(8):989-1002. doi: 10.1016/S1470-2045(24)00270-5.
• Hallick J, Baird AM, Falchook G, Le X, Hong D, Viteri S, Raskin J, Reinmuth N, Vlassak S, Militaru M, Paik PK. Plain language summary of the development of tepotinib: a treatment for a subtype of non-small cell lung cancer called MET exon 14 skipping. Future Oncol. 2023 Mar;19(10):683-696. doi: 10.2217/fon-2022-1035. Epub 2023 Mar 31.

Drugs

Indications