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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
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: AMG 510 Drug: AMG 510
21 day cycles
Active Comparator: Docetaxel Drug: Docetaxel
21 day cycles


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Baseline to approximately 6 years ]
    Defined as time from randomization to death by any cause

  2. Objective Response Rate (ORR) [ Time Frame: Baseline to approximately 6 years ]
    Defined as complete response (CR ) + partial response (PR)

  3. 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)

  4. 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)

  5. 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.

  6. Time to response (TTR) [ Time Frame: Baseline to approximately 6 years ]
    Defined as time from randomization to first evidence of PR or CR

  7. 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

  8. Number of subjects with Clinically significant changes in vital signs [ Time Frame: Approximately 1 year ]
  9. Number of subjects with treatment-emergent adverse events [ Time Frame: Estimated up to approximately 6 years ]
  10. Number of subjects with Clinically significant changes in Laboratory tests [ Time Frame: Estimated up to approximately 1 year ]
  11. Number of Subjects with treatment-related adverse events [ Time Frame: Estimated up to 6 years ]
  12. Maximum plasma concentration (Cmax) [ Time Frame: Estimated up to 4 months ]
    To characterize the pharmacokinetics (PK) of AMG 510

  13. Area under the plasma concentration-time curve (AUC) [ Time Frame: Estimated up to 4 months ]
    To characterize the pharmacokinetics (PK) of AMG 510


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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