NCT04303780 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2026-07-22

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival (PFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
maximum Age: 100 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: AMG 510
label
AMG 510
type
EXPERIMENTAL
intervention Names
Drug: Docetaxel
label
Docetaxel
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
AMG 510
description
21 day cycles
name
AMG 510
type
DRUG
arm Group Labels
Docetaxel
description
21 day cycles
name
Docetaxel
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 345
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Progression-free Survival (PFS)
time Frame
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

Full study description

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

Source references

references

citation
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.
pmid
39303400
type
BACKGROUND
citation
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.
pmid
39846981
type
BACKGROUND
citation
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.
pmid
40437272
type
BACKGROUND
citation
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.
pmid
40129223
type
BACKGROUND
citation
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.
pmid
40774040
type
BACKGROUND
citation
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.
pmid
36764316
type
DERIVED