Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

Summary

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Timeline

Start

2020-06-04

Primary completion

2022-08-02

Completion

2026-06-24

Publications

• Background Waterhouse DM, Rothschild S, Dooms C, Mennecier B, Bozorgmehr F, Majem M, van den Heuvel MH, Linardou H, Chul Cho B, Roberts-Thomson R, Tanaka K, Blais N, Schvartsman G, Holmskov Hansen K, Chmielewska I, Forster MD, Giannopoulou C, Stollenwerk B, Obiozor CC, Wang Y, Novello S. Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation. Lung Cancer. 2024 Oct;196:107921. doi: 10.1016/j.lungcan.2024.107921. Epub 2024 Aug 6.
• Background Skoulidis F, Li BT, Hochmair M, Govindan R, Vincent M, van der Wekken AJ, Reguart Aransay N, O'Byrne KJ, Girard N, Griesinger F, Nishio M, Hafliger S, Lindsay C, Reinmuth N, Paulus A, Papakotoulas P, Kim SW, Ferreira CG, Pasello G, Duruisseaux M, Gennatas S, Dimou A, Mehta B, Kormany W, Nduka C, Sylvester BE, Ardito-Abraham C, Wang Y, de Langen AJ. Pooled safety analysis and management of sotorasib-related adverse events in KRAS G12C-mutated advanced non-small cell lung cancer. Oncologist. 2025 Jan 17;30(1):oyae356. doi: 10.1093/oncolo/oyae356.
• Background Skoulidis F, Li BT, de Langen AJ, Hong DS, Lena H, Wolf J, Dy GK, Curioni Fontecedro A, Tomasini P, Velcheti V, van der Wekken AJ, Dooms C, Paz-Ares Rodriguez L, Mountzios G, Sacher A, Nadal E, Couraud S, Kim SW, O'Byrne K, Rocco D, Toyozawa R, Chmielewska I, Lindsay CR, Hindoyan A, Mukundan L, Wilmanski T, Anderson A, Ardito-Abraham C, Pati A, Reddy A, Mehta B, Schuler M. Molecular determinants of sotorasib clinical efficacy in KRASG12C-mutated non-small-cell lung cancer. Nat Med. 2025 Aug;31(8):2755-2767. doi: 10.1038/s41591-025-03732-5. Epub 2025 May 28.
• Background de Langen AJ, Johnson ML, Mazieres J, Dingemans AC, Mountzios G, Pless M, Wolf J, Schuler M, Lena H, Skoulidis F, Yoneshima Y, Kim SW, Linardou H, Novello S, van der Wekken AJ, Chen Y, Peters S, Felip E, Solomon BJ, Ramalingam SS, Dooms C, Lindsay CR, Ferreira CG, Blais N, Obiozor CC, Wang Y, Mehta B, Varrieur T, Ngarmchamnanrith G, Stollenwerk B, Waterhouse D, Paz-Ares L; CodeBreaK 200 Investigators. Sotorasib versus docetaxel for previously treated KRAS G12C-mutated non-small-cell lung cancer: a plain language summary. Future Oncol. 2025 Apr;21(9):1033-1044. doi: 10.1080/14796694.2025.2474789. Epub 2025 Mar 24.
• Background Dingemans AC, Syrigos K, Livi L, Paulus A, Kim SW, Chen Y, Felip E, Griesinger F, Ohashi K, Zalcman G, Hughes BGM, Sorensen JB, Blais N, Ferreira CGM, Lindsay CR, Dziadziuszko R, Ward PJ, Obiozor CC, Wang Y, Peters S. Intracranial activity of sotorasib vs docetaxel in pretreated KRAS G12C-mutated advanced non-small cell lung cancer from a global, phase 3, randomized controlled trial. Lung Cancer. 2025 Sep;207:108683. doi: 10.1016/j.lungcan.2025.108683. Epub 2025 Jul 29.
• de Langen AJ, Johnson ML, Mazieres J, Dingemans AC, Mountzios G, Pless M, Wolf J, Schuler M, Lena H, Skoulidis F, Yoneshima Y, Kim SW, Linardou H, Novello S, van der Wekken AJ, Chen Y, Peters S, Felip E, Solomon BJ, Ramalingam SS, Dooms C, Lindsay CR, Ferreira CG, Blais N, Obiozor CC, Wang Y, Mehta B, Varrieur T, Ngarmchamnanrith G, Stollenwerk B, Waterhouse D, Paz-Ares L; CodeBreaK 200 Investigators. Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial. Lancet. 2023 Mar 4;401(10378):733-746. doi: 10.1016/S0140-6736(23)00221-0. Epub 2023 Feb 7.

Drugs

Indications

No indication recorded.