Last updated 33 days ago
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)
400 patients around the world
Available in United States, Argentina, Brazil
Hoffmann-La Roche
8Research sites
400Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology.Participants must have had complete resection of NSCLC.Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy.Participants must be randomized within 12 weeks of their surgery date.No evidence of disease recurrence or metastatic disease.Documentation of the presence of a KRAS G12C mutation.
- Participants who achieve pCR following neoadjuvant treatment.Prior treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol.Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection.Resolved Grade 3 or greater immune-related AE or unresolved Grade 2 or greater immune-related AE from neoadjuvant immunotherapy.Active or history of autoimmune disease or immune deficiency.Significant cardiovascular disease.
Sites
Centro Oncológico Korben
Recruiting
Sanatorio de la Mujer - Rosario
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Instituto Argentino de Diagnóstico y Tratamiento - IADT
Recruiting
Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
Recruiting
Cenatron Centro Avançado de Tratamento Oncológico
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
StudyKRASCENDO 3
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07541170
