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)
Klinikum der LMU Muenchen 80366 Muenchen (Bayern) GermanyRekrutierend» Google-MapsUniversity of Illinois at Chicago 60612 Chicago United StatesRekrutierend» Google-MapsNorton Cancer Institute - Brownsboro 40241 Louisville United StatesRekrutierend» Google-MapsUniversity of New Mexico Cancer Center 87131 Albuquerque United StatesRekrutierend» Google-MapsDuke University Medical Center 27710 Durham United StatesRekrutierend» Google-MapsUniversity of Pittsburgh Medical Center Hillman Cancer Center 15232 Pittsburgh United StatesRekrutierend» Google-MapsUniversity of Tennessee Medical Center Knoxville 37920 Knoxville United StatesRekrutierend» Google-MapsHospital Britanico de Buenos Aires C1280AEB Caba ArgentinaRekrutierend» Google-MapsInstituto Alexander Fleming C1426ANZ Capital Federal ArgentinaRekrutierend» Google-MapsInstituto Argentino de Diagnostico y Tratamiento IADT C1012AAR Ciudad Autónoma de Buenos Aires ArgentinaRekrutierend» Google-MapsFundacion Ars Medica 4600 San Salvador de 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1. Progression-free Survival (PFS) (Time Frame - From Baseline up to end of study (EOS) (approximately 5.5 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:
1. Objective Response Rate (ORR) (Time Frame - From Baseline up to 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.
2. Overall Survival (OS) (Time Frame - From Baseline up to EOS (approximately 5.5 years)): OS is defined as the time from randomization until death due to any cause.
3. Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score (Time Frame - From Baseline to Week 12)
4. Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale (Time Frame - From Baseline to Week 12)
5. Change in QLQ-LC13 Symptoms of Cough Subscale (Time Frame - From Baseline to Week 12)
6. Change in QLQ-LC13 Symptoms of Chest Pain Subscale (Time Frame - From Baseline to Week 12)
7. Change in Physical Function as Measured by QLQ-C30 (Time Frame - From Baseline to Week 12)
8. Change in Global Health Status as Measured by QLQ-C30 (Time Frame - From Baseline to Week 12)
9. Progression-free Survival 2 (PFS2) (Time Frame - 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 treatment beyond progression (ie, second progression) or death from any cause, whichever occurs first.
10. Change in QLQ-LC13 Subscale Scores (Time Frame - From Baseline up to EOS (approximately 5.5 years))
11. Change in QLQ-C30 Subscale Scores (Time Frame - From Baseline up to EOS (approximately 5.5 years))
12. Time to Deterioration in QLC-LC13 Subscale Scores (Time Frame - From Baseline to Week 12)
13. Time to Deterioration in QLC-C30 Subscale Scores (Time Frame - From Baseline to Week 12)
14. Change in Summary Scores and Visual Analogue Scale (VAS) Scores (Time Frame - From Baseline up to EOS (approximately 5.5 years)): Measured by EuroQol-5 Dimension (EQ-5D-5L).
15. Duration of Response (Time Frame - 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.
16. Time to Response (Time Frame - From Baseline up to EOS (approximately 5.5 years)): Defined as the time from randomization to first evidence of PR or CR per BICR.
17. Disease Control (Time Frame - From Baseline up to EOS (approximately 5.5 years)): Defined as CR plus PR plus stable disease based on RECIST v1.1 per BICR.
18. PFS (Time Frame - From Baseline up to EOS (approximately 5.5 years)): Based on investigator tumor assessments per RECIST v1.1.
19. Objective Response (Time Frame - From Baseline up to EOS (approximately 5.5 years)): Based on investigator tumor assessments per RECIST v1.1.
20. Number of Participants With Treatment-Emergent Adverse Events (Time Frame - From Baseline up to EOS (approximately 5.5 years))
21. Number of Participants With Clinically Significant Changes in Vital Signs (Time Frame - From Baseline up to EOS (approximately 5.5 years))
22. Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests (Time Frame - From Baseline up to EOS (approximately 5.5 years))
23. Maximum Plasma Concentration (Cmax) of Sotorasib (Time Frame - Pre-dose Day 1 up to Day 64)
24. Minimum Plasma Concentration (Cmin) of Sotorasib (Time Frame - Pre-dose Day 1 up to Day 64)
25. Area Under The Curve (AUC) of Sotorasib (Time Frame - Pre-dose Day 1 up to Day 64)
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"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)"
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