CodeBreaK 200
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
- NCT04303780 ↗
- Completed
- Amgen
- Deep
We haven't built an HCP commentary report on CodeBreaK 200 (AMG 510 and docetaxel in KRAS p, G12c Mutated /Advanced Metastatic NSCLC) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Questions raised in the commentary
Automated, Oct 29, 2026. Not an Erudio report: no source links. Not medical advice.
The commentary discusses CodeBreaK 200’s comparison of sotorasib with docetaxel, patient-reported outcomes, and how trial design affects interpretation. Speakers raise concerns about randomization, open-label bias, blinded independent review, censoring, and the reliability of progression-free survival assessment. Crossover and post-protocol care are discussed in relation to whether overall-survival effects can be interpreted, including whether a survival decrement can be excluded. Commentary also considers the control regimen, the clinical meaning of hazard ratios, and whether the evidence supports regular FDA approval or changes practice.
Indexed commentary on CodeBreaK 200 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 81 | |
| Podcasts | 35 | |
| YouTube | 28 | |
| Bluesky threads | 2 |
The trial
ClinicalTrials.gov- Official title
- A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
- Phase
- Phase 3
- Status
- Completed
- Conditions
- KRAS p, G12c Mutated /Advanced Metastatic NSCLC
- Interventions
- AMG 510; Docetaxel
- Arms
- AMG 510 · Experimental
- Docetaxel · Active comparator
- Enrollment
- 345
- Primary outcomes
- Progression-free Survival (PFS)
- Sponsor
- Amgen
- Start
- Jun 4, 2020
- Primary completion
- Aug 2, 2022
- Results posted
- Yes
- Registry record
- NCT04303780 · updated Jul 22, 2026
Publications
linked from the registry- 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. PubMed 39303400
- 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. PubMed 39846981
- 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. PubMed 40437272
- 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. PubMed 40129223
- 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. PubMed 40774040
- 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. PubMed 36764316