Description:
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC)
subjects with KRAS p. G12c mutation
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
| Drug | Synonyms | Arms |
|---|
| AMG 510 | | AMG 510 |
| Docetaxel | | Docetaxel |
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
| Name | Type | Description | Interventions |
|---|
| AMG 510 | Experimental | | |
| Docetaxel | Active Comparator | | |
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
| 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) per Response Evaluation Criteria in Solid Tumors version (RECIST) v1.1 of at least 6 weeks |
| Measure: | Number of subjects with Clinically significant changes in vital signs |
| Time Frame: | Approximately 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: | Active, not recruiting |
| Lead Sponsor: | Amgen |
Last Updated
June 18, 2021
