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)

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Treatments: Drug: Sotorasib; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05920356

20190341

2022-501863-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Sotorasib combined with carboplatin and pemetrexed

Experimental group

Description:

Sotorasib administered in combination with carboplatin and pemetrexed.

Treatment:

Drug: Sotorasib

Pembrolizumab combined with carboplatin and pemetrexed

Active Comparator group

Description:

Pembrolizumab administered in combination with carboplatin and pemetrexed.

Treatment:

Drug: Pembrolizumab