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A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer
320 patients around the world
Available in Brazil, United States, Argentina
Hoffmann-La Roche
5Research sites
320Patients 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
- Unequivocal histologically or cytologically confirmed diagnosis of unresectable Stage IIIc, per the American Joint Committee on Cancer staging system (AJCC) (Amin et al. 2017) not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC.Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the metastatic setting.Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.Documentation of the presence of a KRAS G12C mutation.Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Life expectancy of >= 12 weeks.
- Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib.Malabsorption syndrome or other condition that would interfere with enteral absorption.Known concomitant second oncogenic driver.Mixed small-cell lung cancer or large cell neuroendocrine histology.Known and untreated, or active central nervous system (CNS) metastases.Leptomeningeal disease or carcinomatous meningitis.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently.Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1.Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor.More than 30 Gy of radiotherapy to the lung within 6 months of randomization.Uncontrolled tumor-related pain.Unresolved toxicities from prior anticancer therapy.History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Centro Oncológico Korben
Recruiting
Sanatorio Parque - Rosario
Recruiting
Hospital Nossa Senhora da Conceição
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
StudyKrascendo 1
SponsorHoffmann-La Roche
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06497556
