Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04303780
Recruitment Status : Not yet recruiting
First Posted : March 11, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 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
Estimated Study Start Date : May 29, 2020
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 6, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: AMG 510 Drug: AMG 510
21 day cycles

Active Comparator: Docetaxel Drug: Docetaxel
21 day cycles




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) of at least 6 weeks

  8. Number of subjects with Clinically significant changes in vital signs [ Time Frame: Aproximately 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



Information from the National Library of Medicine

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.


Layout table for eligibility information
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 molecular testing

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

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
Layout table for location contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
Additional Information:
Layout table for additonal information
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 24, 2020
Last Verified: April 2020
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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