Trial NCT05920356
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)
- Phase
- Phase 3
- Sponsor
- Amgen
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Ages
- 18–100 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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) ≤ 1Performance status
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 metastasesBrain metastases
* Gastrointestinal (GI) tract disease causing the inability to take oral medication
* Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable anginaCardiac
* Prior therapy with a KRAS G12C inhibitor
Restrictions found (3)
- Brain metastasesConditionalexclusionShow in the text
- CardiacConditionalexclusion
MI within 6 months
Show in the text - Performance statusOutrightinclusion
ECOG ≤ 1
Show in the text
Recruiting in Massachusetts
- Reliant Medical Group Inc · Worcester, Worcester County