Tests sotorasib with chemotherapy against pembrolizumab with chemotherapy in lung cancer
Tests sotorasib with chemotherapy in adults with advanced KRAS G12C lung cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Alexandroupoli, Athens, Maroussi, Patras, Pireas, and Thessaloniki, GreeceSee the 9 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced nonsquamous lung cancer (NSCLC) that has a KRAS p.G12C change and is negative for PD-L1, and who have not had earlier treatment for the spread cancer.
- Age
- 18 to 100 years
- Sex
- All sexes can join.
- Disease stage
- Nonsquamous non-small cell lung cancer, stage IV or advanced stage IIIB or IIIC.
- Earlier treatment
- No earlier systemic anticancer treatment for cancer that has spread or cannot be cured. Earlier treatment with a KRAS G12C inhibitor is not allowed.
- Biomarker or test result
- The tumour must have the KRAS p.G12C mutation and be negative for PD-L1, confirmed by central testing.
Main reasons for not taking part
- Mixed lung cancer with a small-cell or large-cell neuroendocrine part, or mostly squamous cells
- Tumour change for which a targeted first treatment is locally approved
- Brain metastases that cause symptoms, treated or not
- Gut disease that makes it impossible to take tablets or capsules
- Heart attack in the last 6 months, unstable heart rhythm problems or unstable angina
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- What was the PD-L1 result of your tumour test?
- Has your cancer spread to the brain?
Source: NCT05920356, who can take part
Where in Greece
- University General Hospital of AlexandroupoliAlexandroupoli, GreeceTaking people
- 251 Air Force General HospitalAthens, GreeceTaking people
- Alexandra HospitalAthens, GreeceTaking people
- Athens Medical Center S.A.Maroussi, GreeceTaking people
- General University Hospital Of PatrasPatras, GreeceTaking people
- Metaxa Cancer Center Hospital Of PiraeusPireas, GreeceTaking people
- Metropolitan HospitalPireas, GreeceTaking people
- Athens Medical Center S.A.Thessaloniki, GreeceTaking people
- Theageneio Cancer HospitalThessaloniki, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen
- Trial code
- NCT05920356EU 2022-501863-41-00
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy; Prior therapy with a KRAS G12C inhibitor; Gastrointestinal (GI) tract disease causing the inability to take oral medication; Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina; Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology; Symptomatic (treated or untreated) brain metastases.