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)
Recruiting · NCT05920356 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
- Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
- 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
Where it is running
60 locations listed across 15 US states.
- Sansum Clinic - Santa Barbara, California, United States
- Medical Oncology Hematology Consultants Helen F Graham Cancer Center - Newark, Delaware, United States
- Boca Raton Clinical Research Coral Springs - Coral Springs, Florida, United States
- Florida Clinical Trials Group Plantation - Plantation, Florida, United States
- Florida Clinical Trials Group Tamarac - Tamarac, Florida, United States
- University of Illinois Chicago - Chicago, Illinois, United States
- Illinois Cancer Specialists - Niles, Illinois, United States
- Norton Cancer Institute - Brownsboro - Louisville, Kentucky, United States
- Reliant Medical Group Inc - Worcester, Massachusetts, United States
- University of New Mexico Cancer Center - Albuquerque, New Mexico, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Messino Cancer Centers Asheville - Asheville, North Carolina, United States
- Duke University Medical Center - Durham, North Carolina, United States
- FirstHealth Cancer Center - Pinehurst, North Carolina, United States
- Dayton Physician's Network - Dayton, Ohio, United States
- Alliance Cancer Specialists - Media - Media, Pennsylvania, United States
- University of Pittsburgh Medical Center Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- Guthrie Medical Group - Sayre, Pennsylvania, United States
- University of Tennessee Medical Center Knoxville - Knoxville, Tennessee, United States
- Regional One Health - Memphis, Tennessee, United States
- Sarah Cannon Research Institute - Nashville, Tennessee, United States
- United States Oncology Regulatory Affairs Corporate Office - Nashville, Tennessee, United States
- Oncology Consultants PA - Houston, Texas, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- US Oncology Research Investigational Products Center - Irving, Texas, United States
- Vista Oncology Inc PS - Olympia, Washington, United States
- Mercyhealth - Janesville, Wisconsin, United States
- Kantonsspital Aarau - Aarau, Switzerland
- Aarhus Universitetshospital - Aarhus N, Denmark
- Medical Park Seyhan Hastanesi - Adana, Turkey (Türkiye)
- Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi - Adana, Turkey (Türkiye)
- University General Hospital of Alexandroupoli - Alexandroupoli, Greece
- Meander Medisch Centrum - Amersfoort, Netherlands
- Hacettepe Universitesi Tip Fakultesi Hastanesi - Ankara, Turkey (Türkiye)
- Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi - Ankara, Turkey (Türkiye)
- Liv Hospital Ankara - Ankara, Turkey (Türkiye)
- Ankara Bilkent Sehir Hastanesi - Ankara, Turkey (Türkiye)
- Akdeniz Universitesi Tip Fakultesi - Antalya, Turkey (Türkiye)
- Centro de Investigacion Vallesur - Arequipa, Peru
- 251 General Airforce Hospital - Athens, Greece
- Henry Dunant Hospital Center - Athens, Greece
- Alexandra Hospital - Athens, Greece
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - Athens, Greece
- Iaso Hospital - Athens, Greece
- Metropolitan Hospital - Athens, Greece
- Chirec - Delta Ziekenhuis - Auderghem, Belgium
- Aydin Adnan Menderes Universitesi Tip Fakultesi - Aydin, Turkey (Türkiye)
- Kantonsspital Baden - Baden, Switzerland
- Vajira Hospital - Bangkok, Thailand
- King Chulalongkorn Memorial Hospital - Bangkok, Thailand
- Phramongkutklao Hospital - Bangkok, Thailand
- IRCCS Istituto Tumori Giovanni Paolo II - Bari, Italy
- Centro Cancerologico del Caribe LTDA CECAC - Barranquilla, Colombia
- Universitaetsspital Basel - Basel, Switzerland
- Centre Hospitalier de la Cote Basque - Bayonne, France
- Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz - Besançon, France
- Uniwersytecki Szpital Kliniczny w Bialymstoku - Bialystok, Poland
- Queen Elizabeth Hospital Birmingham - Birmingham, United Kingdom
- Centre Hospitalier Universitaire Ambroise Pare - Boulogne-Billancourt, France
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Brescia, Italy
Showing 60 of 418 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →