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
- Adana, Ankara, Antalya, Aydin, Denizli, Istanbul, Izmir, and Samsun, TürkiyeSee the 22 sites
- Phase
- Phase 3
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 Türkiye
- Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma MerkeziAdana, TürkiyeTaking people
- Medical Park Seyhan HastanesiAdana, TürkiyeTaking people
- Ankara Bilkent Sehir HastanesiAnkara, TürkiyeTaking people
- Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi HastanesiAnkara, TürkiyeTaking people
- Hacettepe Universitesi Tip Fakultesi HastanesiAnkara, TürkiyeTaking people
- Liv Hospital AnkaraAnkara, TürkiyeTaking people
- Akdeniz Universitesi Tip FakultesiAntalya, TürkiyeTaking people
- Aydin Adnan Menderes Universitesi Tip FakultesiAydin, TürkiyeTaking people
- Pamukkale Universitesi Tip Fakultesi HastanesiDenizli, TürkiyeNo longer taking part
- Acibadem Maslak HastanesiIstanbul, TürkiyeTaking people
- Bagcilar Medipol Mega Universite HastanesiIstanbul, TürkiyeTaking people
- Goztepe Prof. Dr. Suleyman Yalcin Sehir HastanesiIstanbul, TürkiyeTaking people
- Istanbul Bakirkoy Doktor Sadi Konuk Egitim ve Arastirma HastanesiIstanbul, TürkiyeTaking people
- Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, TürkiyeTaking people
- Istinye Universitesi Hastanesi Medical Park GaziosmanpasaIstanbul, TürkiyeTaking people
- Kartal Dr Lutfi Kirdar Sehir HastanesiIstanbul, TürkiyeTaking people
- Prof Dr Cemil Tascioglu Sehir HastanesiIstanbul, TürkiyeTaking people
- Marmara Universitesi Tip Fakultesi HastanesiIstanbul, TürkiyeNo longer taking part
- Memorial Bahcelievler HastanesiIstanbul, TürkiyeNo longer taking part
- Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma HastanesiIzmir, TürkiyeTaking people
- Izmir Ekonomi Universitesi Medical Point HastanesiIzmir, TürkiyeTaking people
- Ondokuz Mayis Universitesi Tip Fakultesi HastanesiSamsun, TürkiyeNo longer taking part
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.