Clinical trial · Interventional
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
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
NCT04303780CI-TRIAL-00118941completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| KRAS p, G12c Mutated /Advanced Metastatic NSCLC | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AMG 510
- interventionNames
- Drug: AMG 510
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months
- description
- PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Men or women greater than or equal to 18 years old. * ECOG ≤ 1 * Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment Exclusion Criteria: * Active brain metastases * Myocardial infarction within 6 months of study day 1 * Gastrointestinal (GI) tract disease causing the inability to take oral medication
References
Publications (6)
- BACKGROUNDWaterhouse 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. PMID 39303400
- BACKGROUNDSkoulidis 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. PMID 39846981
- BACKGROUNDSkoulidis 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. PMID 40437272
- BACKGROUNDde 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.