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
- Bunkyo-ku, Chiba, Fukuoka, Fukuyama-shi, Hirakata-shi, Hirosaki-shi, Kanazawa, Kashiwa-shi, Kawasaki-shi, Kitakyushu-shi, Kobe, Koto-ku, Kurume-shi, Kyoto, Matsuyama, Nagoya, Natori-shi, Niigata, Okayama, Osaka, Sakai-shi, Sakai-Shi, Sapporo, Sendai, Shimotsuga-gun, Sunto-gun, Takarazuka-shi, Toon-shi, Ube-shi, Wakayama, Yokohama, and Yonago-shi, JapanSee the 33 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 Japan
- Juntendo University HospitalBunkyo-ku, JapanTaking people
- Saitama Cancer CenterBunkyo-ku, JapanTaking people
- Chiba Cancer CenterChiba, JapanTaking people
- National Hospital Organization Kyushu Cancer CenterFukuoka, JapanTaking people
- Chugoku Central Hospital of Japan Mutual Aid Association of Public School TeachersFukuyama-shi, JapanTaking people
- Kansai Medical University HospitalHirakata-shi, JapanTaking people
- Hirosaki University HospitalHirosaki-shi, JapanTaking people
- Kanazawa University HospitalKanazawa, JapanTaking people
- National Cancer Center Hospital EastKashiwa-shi, JapanTaking people
- St. Marianna University HospitalKawasaki-shi, JapanTaking people
- Hospital of the University of Occupational and Environmental Health, JapanKitakyushu-shi, JapanTaking people
- Kobe Minimally Invasive Cancer CenterKobe, JapanTaking people
- The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchKoto-ku, JapanTaking people
- Kurume University HospitalKurume-shi, JapanTaking people
- Kyoto University HospitalKyoto, JapanTaking people
- National Hospital Organization Shikoku Cancer CenterMatsuyama, JapanTaking people
- Nagoya University HospitalNagoya, JapanTaking people
- Miyagi Cancer CenterNatori-shi, JapanTaking people
- Niigata Cancer Center HospitalNiigata, JapanTaking people
- Okayama University HospitalOkayama, JapanTaking people
- Osaka International Cancer InstituteOsaka, JapanTaking people
- Kindai University HospitalSakai-shi, JapanTaking people
- National Hospital Organization Kinki-Chuo Chest Medical CenterSakai-Shi, JapanTaking people
- National Hospital Organization Hokkaido Cancer CenterSapporo, JapanTaking people
- Sendai Kousei HospitalSendai, JapanTaking people
- Dokkyo Medical University HospitalShimotsuga-gun, JapanTaking people
- Shizuoka Cancer CenterSunto-gun, JapanTaking people
- Takarazuka City HospitalTakarazuka-shi, JapanTaking people
- Ehime University HospitalToon-shi, JapanTaking people
- National Hospital Organization Yamaguchi-Ube Medical CenterUbe-shi, JapanTaking people
- Wakayama Medical University HospitalWakayama, JapanTaking people
- Kanagawa Prefectural Hospital Organization Kanagawa Cancer CenterYokohama, JapanTaking people
- Tottori University HospitalYonago-shi, JapanTaking 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.