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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 : Active, not recruiting
First Posted : March 11, 2020
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE March 5, 2020
First Posted Date  ICMJE March 11, 2020
Last Update Posted Date June 18, 2021
Actual Study Start Date  ICMJE June 4, 2020
Estimated Primary Completion Date November 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
  • 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) of at least 6 weeks
  • Number of subjects with Clinically significant changes in vital signs [ Time Frame: Aproximately 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE KRAS p, G12c Mutated /Advanced Metastatic NSCLC
Intervention  ICMJE
  • Drug: AMG 510
    21 day cycles
  • Drug: Docetaxel
    21 day cycles
Study Arms  ICMJE
  • Experimental: AMG 510
    Intervention: Drug: AMG 510
  • Active Comparator: Docetaxel
    Intervention: Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 27, 2021)
345
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2020)
650
Estimated Study Completion Date  ICMJE April 27, 2026
Estimated Primary Completion Date November 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Portugal,   Russian Federation,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04303780
Other Study ID Numbers  ICMJE 20190009
2019-003582-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP