Recruiting NCT05920356

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)

Phase III Interventional Non-Small Cell Lung Cancer (NSCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Sotorasib, Pembrolizumab.
Who it may be relevant to: Registry conditions: Non-Small Cell Lung Cancer (NSCLC). Basic parameters: 18 years — 100 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +33
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

Overview

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.

Interventions

Drug Sotorasib
Oral administration
Drug Pembrolizumab
Intravenous administration

Primary outcome measures

Progression-free Survival (PFS) [Time frame: Approximately 2.5 years]
Overall Survival (OS) [Time frame: Approximately 2.5 years]

Secondary outcome measures (12)

Objective Response Rate (ORR) [Time frame: From Baseline up to end of study (EOS) (approximately 5.5 years)]
Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score [Time frame: From Baseline to Week 12]
Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale [Time frame: From Baseline to Week 12]
Change in QLQ-LC13 Symptoms of Cough Subscale [Time frame: From Baseline to Week 12]
Change in QLQ-LC13 Symptoms of Chest Pain Subscale [Time frame: From Baseline to Week 12]
Change in Physical Function as Measured by QLQ-C30 [Time frame: From Baseline to Week 12]
Change in Global Health Status as Measured by QLQ-C30 [Time frame: From Baseline to Week 12]
Progression-free Survival 2 (PFS2) [Time frame: From Baseline up to EOS (approximately 5.5 years)]
Change in QLQ-LC13 Subscale Scores [Time frame: From Baseline up to EOS (approximately 5.5 years)]
Change in QLQ-C30 Subscale Scores [Time frame: From Baseline up to EOS (approximately 5.5 years)]
Time to Deterioration in QLC-LC13 Subscale Scores [Time frame: From Baseline to Week 12]
Time to Deterioration in QLC-C30 Subscale Scores [Time frame: From Baseline to Week 12]

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 as a front-line therapy
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No