A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Interventions
- Registration Number
- NCT05920356
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sotorasib combined with carboplatin and pemetrexed Sotorasib Sotorasib administered in combination with carboplatin and pemetrexed. Pembrolizumab combined with carboplatin and pemetrexed Pembrolizumab Pembrolizumab administered in combination with carboplatin and pemetrexed.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Approximately 2.5 years OS is defined as the time from randomization until death due to any cause.
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).
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (370)
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States
University of Illinois Chicago
🇺🇸Chicago, Illinois, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
Norton Cancer Institute - Brownsboro
🇺🇸Louisville, Kentucky, United States
Reliant Medical Group Inc
🇺🇸Worcester, Massachusetts, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
FirstHealth Cancer Center
🇺🇸Pinehurst, North Carolina, United States
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