Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
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ClinicalTrials.gov Identifier: NCT04303780 |
Recruitment Status :
Recruiting
First Posted : March 11, 2020
Last Update Posted : April 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
KRAS p, G12c Mutated /Advanced Metastatic NSCLC | Drug: AMG 510 Drug: Docetaxel | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 4, 2020 |
Estimated Primary Completion Date : | November 2, 2021 |
Estimated Study Completion Date : | May 1, 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: AMG 510 |
Drug: AMG 510
21 day cycles |
Active Comparator: Docetaxel |
Drug: Docetaxel
21 day cycles |
- Progression-free survival (PFS) [ Time Frame: Baseline to approximately 6 years ]Defined as time from randomization until disease progression or death from any cause, whichever occurs first
- Overall Survival (OS) [ Time Frame: Baseline to approximately 6 years ]Defined as time from randomization to death by any cause
- Objective Response Rate (ORR) [ Time Frame: Baseline to approximately 6 years ]Defined as complete response (CR ) + partial response (PR)
- Patient Reported Outcomes (PRO) [ Time Frame: Baseline to week 12 ]To be assessed by Patient-reported symptoms from selected PRO-Common Terminology Criteria for Adverse Events questions and GP5 of Functional Assessment of Cancer Therapy Tool General form (FACT-G)
- Quality of Life Assessment [ Time Frame: Baseline to week 12 ]To be as assessed by: European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 13 (EORTC QLQ-LC13) and European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30)
- Duration of response (DOR) [ Time Frame: Baseline to approximately 6 years ]Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first.
- Time to response (TTR) [ Time Frame: Baseline to approximately 6 years ]Defined as time from randomization to first evidence of PR or CR
- Disease control rate (DCR) [ Time Frame: Baseline to approximately 6 years ]Defined as rate of confirmed objective response (CR or PR) + stable disease (SD) per Response Evaluation Criteria in Solid Tumors version (RECIST) v1.1 of at least 6 weeks
- Number of subjects with Clinically significant changes in vital signs [ Time Frame: Approximately 1 year ]
- Number of subjects with treatment-emergent adverse events [ Time Frame: Estimated up to approximately 6 years ]
- Number of subjects with Clinically significant changes in Laboratory tests [ Time Frame: Estimated up to approximately 1 year ]
- Number of Subjects with treatment-related adverse events [ Time Frame: Estimated up to 6 years ]
- Maximum plasma concentration (Cmax) [ Time Frame: Estimated up to 4 months ]To characterize the pharmacokinetics (PK) of AMG 510
- Area under the plasma concentration-time curve (AUC) [ Time Frame: Estimated up to 4 months ]To characterize the pharmacokinetics (PK) of AMG 510

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04303780
Contact: Amgen Call Center | 866-572-6436 | medinfo@amgen.com |

Study Director: | MD | Amgen |
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT04303780 |
Other Study ID Numbers: |
20190009 2019-003582-18 ( EudraCT Number ) |
First Posted: | March 11, 2020 Key Record Dates |
Last Update Posted: | April 1, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study |
Access Criteria: | Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below. |
URL: | https://www.amgen.com/datasharing |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |