Studieoverzicht

Study name: CodeBreak 202 -AMGEN20190341 Phase 3 studie 1L Sotorasib UMCG

Histology	NSCLC, only non-squamous
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)
PD-L1 expression	Negative: <1%
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) no history of systemic anticancer therapy in metastatic/incurable settings must provide tumor tissue sample (or be willing to undergo biopsy) for central molecular analysis must be tumor tissue negative for PD-L1 expression (TC  1), tested using SP263 IHC assay in the central laboratory (in selected cases, local laboratory results can be used for study entry and randomization while central laboratory results are pending; see Section 5.1) must be plasma circulating tumor DNA (ctDNA) and/or tumor tissue positive for KRAS p.G12C mutation tested by central laboratory (in selected cases, local laboratory results can be used for study entry and randomization while central laboratory results are pending; see Section 5.1) must have measurable disease as defined by RECIST v1.1 criteria has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1"
Key exclusion criteria	mixed histology NSCLC with either small-cell or large-cell neuroendocrine component (any percentage) or predominant squamous cell histology (more than 50% of the available tumor) tumors known to harbor molecular alterations for which targeted therapy is locally approved (including but not limited to EGFR or ALK alteration) other than KRAS p.G12C active brain metastases, defined as symptomatic (treated or untreated) brain metastases; subjects with asymptomatic untreated metastases or asymptomatic treated brain metastases are eligible if they meet all prespecified criteria (see Section 5.2) active autoimmune disease (see Section 5.2)"
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