BridgeMD
A Phase 3 Study of Front‑line Platinum Doublet Therapy With Sotorasib Versus Pembrolizumab in PD-L1 Negative KRAS p.G12C Positive Advanced/Metastatic NSCLC (CodeBreaK 202)
EU CTIS ID: 2022-501863-41-00
What this study is testing
To compare progression-free survival (PFS) in the participants who receive sotorasib with chemotherapy versus pembrolizumab with chemotherapy To compare overall survival (OS) in the participants who receive sotorasib with chemotherapy versus pembrolizumab with chemotherapy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men or women greater than or equal to 18 years old
- 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
- ECOG ≤ 1
You likely can't join if
- Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
- Subjects 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
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Singapore
- Colombia
- Chile
- Hong Kong
- South Africa
- Canada
- Brazil
- Turkey
- United States
- Thailand
- Peru
- Australia
- Taiwan
- Mexico
- Japan
- China
- Korea, Republic of
- United Kingdom
- Argentina
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Singapore; Colombia; Chile; Hong Kong; South Africa and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.