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)
Non-small Cell Lung Cancer (NSCLC)The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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
* 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 Location
Queen Elizabeth II, Health Sciences Centre
Queen Elizabeth II, Health Sciences CentreHalifax, Nova Scotia
Canada
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Institut Universitaire de cardiologie et de pneumologie de Quebec
Institut Universitaire de cardiologie et de pneumologie de QuebecQuebec City, Quebec
Canada
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CIUSSS - du Nord-de-lIle-de-Montreal / Hopital Sacre-Coeur de Montreal
CIUSSS - du Nord-de-lIle-de-Montreal / Hopital Sacre-Coeur de MontrealMontreal, Quebec
Canada
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Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Sunnybrook Research Institute Sunnybrook Health Sciences CentreToronto, Ontario
Canada
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Allan Blair Cancer Centre
Allan Blair Cancer CentreRegina, Saskatchewan
Canada
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McGill University Health Centre Glen Site
McGill University Health Centre Glen SiteMontreal, Quebec
Canada
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Saskatoon Cancer Centre
Saskatoon Cancer CentreSaskatoon, Saskatchewan
Canada
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- Study Sponsored By
- Amgen
- Participants Required
- More Information
- Study ID:
NCT05920356