Non-Small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Oncology, Lung Cancer, PD-L1, KRAS p.G12C, Sotorasib, Pembrolizumab, Carboplatin, Pemetrexed, CodeBreaK 202, NSCLC, PD-L1 Negative, AMG 510, LUMAKRAS ®, LUMYKRAS ®
Brief summary
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Interventions
DRUGSotorasib
Oral administration
DRUGPembrolizumab
Intravenous administration
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing * No history of systemic anticancer therapy in metastatic/non-curable settings * Eastern Cooperative Oncology Group (ECOG) ≤ 1
Exclusion criteria
* Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology * Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy * Symptomatic (treated or untreated) brain metastases * Gastrointestinal (GI) tract disease causing the inability to take oral medication * Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina * Prior therapy with a KRAS G12C inhibitor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Approximately 2.5 years | PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR). |
| Overall Survival (OS) | Approximately 2.5 years | OS is defined as the time from randomization until death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From Baseline up to end of study (EOS) (approximately 5.5 years) | Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1, per BICR. |
| Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score | From Baseline to Week 12 | — |
| Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale | From Baseline to Week 12 | — |
| Change in QLQ-LC13 Symptoms of Cough Subscale | From Baseline to Week 12 | — |
| Change in QLQ-LC13 Symptoms of Chest Pain Subscale | From Baseline to Week 12 | — |
| Change in Physical Function as Measured by QLQ-C30 | From Baseline to Week 12 | — |
| Change in Global Health Status as Measured by QLQ-C30 | From Baseline to Week 12 | — |
| Progression-free Survival 2 (PFS2) | From Baseline up to EOS (approximately 5.5 years) | PFS2 is defined as the time from randomization to progression per investigator after initiation of new anticancer therapy or death from any cause, whichever occurs first. |
| Change in QLQ-LC13 Subscale Scores | From Baseline up to EOS (approximately 5.5 years) | — |
| Change in QLQ-C30 Subscale Scores | From Baseline up to EOS (approximately 5.5 years) | — |
| Time to Deterioration in QLC-LC13 Subscale Scores | From Baseline to Week 12 | — |
| Time to Deterioration in QLC-C30 Subscale Scores | From Baseline to Week 12 | — |
| Change in Summary Scores and Visual Analogue Scale (VAS) Scores | From Baseline up to EOS (approximately 5.5 years) | Measured by EuroQol-5 Dimension (EQ-5D-5L). |
| Duration of Response | From Baseline up to EOS (approximately 5.5 years) | Duration of response is defined as the time from the first documentation of objective response until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first. |
| Time to Response | From Baseline up to EOS (approximately 5.5 years) | Defined as the time from randomization to first evidence of PR or CR per BICR. |
| Disease Control | From Baseline up to EOS (approximately 5.5 years) | Defined as CR plus PR plus stable disease based on RECIST v1.1 per BICR. |
| PFS | From Baseline up to EOS (approximately 5.5 years) | Based on investigator tumor assessments per RECIST v1.1. |
| Objective Response | From Baseline up to EOS (approximately 5.5 years) | Based on investigator tumor assessments per RECIST v1.1. |
| Number of Participants With Treatment-Emergent Adverse Events | From Baseline up to EOS (approximately 5.5 years) | — |
| Number of Participants With Clinically Significant Changes in Vital Signs | From Baseline up to EOS (approximately 5.5 years) | — |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests | From Baseline up to EOS (approximately 5.5 years) | — |
| Maximum Plasma Concentration (Cmax) of Sotorasib | Pre-dose Day 1 up to Day 64 | — |
| Minimum Plasma Concentration (Cmin) of Sotorasib | Pre-dose Day 1 up to Day 64 | — |
| Area Under The Curve (AUC) of Sotorasib | Pre-dose Day 1 up to Day 64 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Romania, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed