Clinical Trials /

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

NCT04303780

Description:

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 20190009
  • SECONDARY ID: 2019‐003582‐18
  • NCT ID: NCT04303780

Conditions

  • KRAS p, G12c Mutated /Advanced Metastatic NSCLC

Interventions

DrugSynonymsArms
AMG 510AMG 510
DocetaxelDocetaxel

Purpose

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Trial Arms

NameTypeDescriptionInterventions
AMG 510Experimental
  • AMG 510
DocetaxelActive Comparator
  • Docetaxel

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 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
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:Baseline to approximately 6 years
Safety Issue:
Description:Defined as time from randomization until disease progression or death from any cause, whichever occurs first

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Baseline to approximately 6 years
Safety Issue:
Description:Defined as time from randomization to death by any cause
Measure:Objective Response Rate (ORR)
Time Frame:Baseline to approximately 6 years
Safety Issue:
Description:Defined as complete response (CR ) + partial response (PR)
Measure:Patient Reported Outcomes (PRO)
Time Frame:Baseline to week 12
Safety Issue:
Description: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)
Measure:Quality of Life Assessment
Time Frame:Baseline to week 12
Safety Issue:
Description: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)
Measure:Duration of response (DOR)
Time Frame:Baseline to approximately 6 years
Safety Issue:
Description:Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first.
Measure:Time to response (TTR)
Time Frame:Baseline to approximately 6 years
Safety Issue:
Description:Defined as time from randomization to first evidence of PR or CR
Measure:Disease control rate (DCR)
Time Frame:Baseline to approximately 6 years
Safety Issue:
Description:Defined as rate of confirmed objective response (CR or PR) + stable disease (SD) of at least 6 weeks
Measure:Number of subjects with Clinically significant changes in vital signs
Time Frame:Aproximately 1 year
Safety Issue:
Description:
Measure:Number of subjects with treatment-emergent adverse events
Time Frame:Estimated up to approximately 6 years
Safety Issue:
Description:
Measure:Number of subjects with Clinically significant changes in Laboratory tests
Time Frame:Estimated up to approximately 1 year
Safety Issue:
Description:
Measure:Number of Subjects with treatment-related adverse events
Time Frame:Estimated up to 6 years
Safety Issue:
Description:
Measure:Maximum plasma concentration (Cmax)
Time Frame:Estimated up to 4 months
Safety Issue:
Description:To characterize the pharmacokinetics (PK) of AMG 510
Measure:Area under the plasma concentration-time curve (AUC)
Time Frame:Estimated up to 4 months
Safety Issue:
Description:To characterize the pharmacokinetics (PK) of AMG 510

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Amgen

Last Updated

March 9, 2020