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

• ClinicalTrials.gov Identifier: NCT04303780
• Recruitment Status: Active, not recruiting
• First Posted: March 11, 2020
• Last Update Posted: November 14, 2022
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: March 5, 2020
• First Posted Date: March 11, 2020
• Last Update Posted Date: November 14, 2022
• Actual Study Start Date: June 4, 2020
• Actual Primary Completion Date: August 2, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: KRAS p, G12c Mutated /Advanced Metastatic NSCLC

Intervention

• Drug: AMG 510
  21 day cycles
• Drug: Docetaxel
  21 day cycles

Study Arms

• Experimental: AMG 510
  Intervention: Drug: AMG 510
• Active Comparator: Docetaxel
  Intervention: Drug: Docetaxel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 27, 2021): 345
• Original Estimated Enrollment (submitted: March 9, 2020): 650
• Estimated Study Completion Date: April 27, 2026
• Actual Primary Completion Date: August 2, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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

Administrative Information

• NCT Number: NCT04303780
• Other Study ID Numbers: 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

• 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

• Current Responsible Party: Amgen
• Original Responsible Party: Same as current
• Current Study Sponsor: Amgen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: November 2022