Studieoverzicht
Study name: CodeBreak 202 -AMGEN20190341 Phase 3 studie 1L Sotorasib UMCG
Histology | NSCLC | ||
---|---|---|---|
Tumor stage | Stage III - IV | ||
Host / recruiting site 1 | UMC Groningen | Enrollment | Recruiting |
Host / recruiting site 2 | MUMC+ | Enrollment | Recruiting |
Therapy line | First line (1L) | ||
Design |
This is a phase 3, international, multicenter, randomized, open-label study to evaluate the efficacy and safety of sotorasib in combination with carboplatin and pemetrexed versus pembrolizumab in combination with carboplatin and pemetrexed in front-line setting in subjects with Stage IV or advanced Stage IIIB/C nonsquamous PD-L1 negative and KRAS p.G12C-mutation positive NSCLC. |
||
Intervention | Platinum-pemetrexed-pembrolizumab vs platinum-pemetrexed-sotorasib |
||
Key outcome parameters | To compare progression-free survival (PFS) in subjects who receive sotorasib with platinum doublet chemotherapy versus subjects who receive pembrolizumab with platinum doublet chemotherapy |
||
Key inclusion criteria | Stage IV or advanced Stage IIIB/C NSCLC (not a candidate for definitive multimodality therapy due to the extent of disease)
|
||
Key exclusion criteria | mixed histology NSCLC with either small-cell or large-cell neuroendocrine component (any percentage) or predominant squamous cell histology (more than
|
||
Contact information | Log in voor de contactinformatie |