Clinical trial
A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)
Name
20190341
Description
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.
Trial arms
Trial start
2023-11-16
Estimated PCD
2026-02-28
Trial end
2031-03-01
Status
Recruiting
Phase
Early phase I
Treatment
Sotorasib
Oral administration
Arms:
Sotorasib combined with carboplatin and pemetrexed
Other names:
AMG 510, LUMYKRAS ®, LUMAKRAS ®
Pembrolizumab
Intravenous administration
Arms:
Pembrolizumab combined with carboplatin and pemetrexed
Size
750
Primary endpoint
Progression-free Survival (PFS)
From Baseline up to end of study (EOS) (approximately 5.5 years)
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 750, 'type': 'ESTIMATED'}}
Updated at
2024-05-09
1 organization
2 products
1 abstract
1 indication
Organization
AmgenProduct
PembrolizumabIndication
non-small cell lung cancerProduct
SotorasibAbstract
Sotorasib versus pembrolizumab in combination with platinum doublet chemotherapy as first-line treatment for metastatic or locally advanced, PD-L1 negative, KRAS G12C-mutated NSCLC (CodeBreaK 202).Org: The Royal Marsden Hospital and The Institute of Cancer Research,