Taking people in ItalyPhase 3
Tests sotorasib with chemotherapy against pembrolizumab with chemotherapy in lung cancer
Tests sotorasib with chemotherapy in adults with advanced KRAS G12C lung cancer.
Key facts
- Who runs it
- Amgen
- Where
- Bari, Brescia, Candiolo, Catania, Florence, Meldola, Milan, Monza, Naples, Parma, Perugia, Pesaro, Pisa, Rome, and Udine, ItalySee the 16 sitesAlso in 37 other countries, 390 sites
- Trial code
- NCT05920356
- EU 2022-501863-41-00
- U1111-1293-2431
- 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)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 750 people, planned
- Started
- 16 Nov 2023
- Expected to end
- 29 Jun 2032
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Sotorasib
- Pembrolizumab
- Record updated
- 13 November 2026
Who can take part
AI summary
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
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Italy
Also in 37 other countries, 390 sites
- Istituto Tumori Bari Giovanni Paolo IIBari, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCSCandiolo, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
- Careggi University HospitalFlorence, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Ospedaliera dei ColliNaples, ItalyTaking people
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
- Azienda Ospedaliero Universitaria ParmaParma, ItalyTaking people
- Hospital Santa Maria Della MisericordiaPerugia, ItalyTaking people
- Azienda Sanitaria Territoriale di Pesaro e UrbinoPesaro, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Sotorasib combined with carboplatin and pemetrexedTreatment being tested
Sotorasib administered in combination with carboplatin and pemetrexed.
Treatment: Sotorasib
- Pembrolizumab combined with carboplatin and pemetrexedExisting treatment, for comparison
Pembrolizumab administered in combination with carboplatin and pemetrexed.
Treatment: Pembrolizumab
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Tests sotorasib with chemotherapy against pembrolizumab with chemotherapy in lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05920356, who can take part
- Record updated
- 13 November 2026