The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Divarasib will be administered orally as per the schedule specified in the respective arm.
Pembrolizumab will be administered as either a 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) or 395 mg subcutaneous (SC) injection Q3W, for up to 13 cycles (1 cycle = 21 days).
Nivolumab will be administered as either a 480 mg IV infusion, every 4 weeks (Q4W) or 1200 mg SC injection Q4W, for up to 13 cycles (1 cycle = 28 days).
Community Cancer Institute (CCI)
Clovis, California, United States
RECRUITINGPiedmont Cancer Institute, PC
Atlanta, Georgia, United States
RECRUITINGProfound Research, LLC
Farmington Hills, Michigan, United States
RECRUITINGCancer Care Specialists
Reno, Nevada, United States
RECRUITINGSan Juan Oncology Associates
Farmington, New Mexico, United States
RECRUITINGSanatorio de la Mujer
Rosario, Santa Fe Province, Argentina
RECRUITINGInstituto Argentino de Diagnóstico y Tratamiento- IADT
Capital Federal, Argentina
RECRUITINGHospital Britanico
Ciudad Autonoma Buenos Aires, Argentina
RECRUITINGCentro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina
RECRUITINGClinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina
RECRUITING...and 9 more locations
Disease-free Survival (DFS), as Determined by the Investigator
Time frame: From randomization to disease recurrence or death from any cause (Up to approximately 5 years)
Overall Survival (OS)
Time frame: From date of randomization to death from any cause (up to approximately 8 years)
DFS Rates at 2 and 3 Years, as Assessed by the Investigator
Time frame: At Year 2 and Year 3
Number of Participants With Adverse Events (AEs)
Time frame: From randomization to 60 days after the end of study treatment (up to approximately 8 years)
Reference Study ID Number: BO45885 https://forpatients.roche.com/ No attachments to email below.
CONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.