- 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) — Recruiting • Phase III • Oncology • NCT05920356.
- What is being tested: Sotorasib (a KRAS G12C inhibitor) combined with platinum doublet chemotherapy versus pembrolizumab (PD-L1 inhibitor) combined with platinum doublet chemotherapy as first-line treatment, with primary endpoints of progression-free survival and overall survival.
- Patient eligibility overview: Adults with stage IV or advanced stage IIIB/C nonsquamous non-small cell lung cancer (NSCLC) who are treatment-Phase IIIïve and have KRAS G12C mutations (for the sotorasib arm) or are unselected for biomarkers (for the pembrolizumab arm).
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.