A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF IVARASIB COMPARED WITH INVESTIGATOR'S CHOICE OF IMMUNOTHERAPY OR OBSERVATION IN PATIENTS WITH RESECTED STAGE II-III KRAS G12C-POSITIVE NON-SMALL CELL LUNG CANCER

未提供0 个研究点目标入组 400 人开始时间: 待定

适应症

试验速览

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•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
•Patients 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 adverse event or unresolved Grade 2 or greater immune-related adverse event from neoadjuvant immunotherapy
•Active or history of autoimmune disease or immune deficiency
•Significant cardiovascular disease

发起方

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