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NCT07541170phase 3recruiting
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
Enrollment · estimated
1
Countries · 1 sites
2032-01
Primary completion
1 mo ago
Record updated
Commercial relevance
Trial record references molecular eligibility required.
Molecular eligibility required
Change timeline
Signals from this trial
- New trial48/100Opportunity
New phase 3 trial NCT07541170 posted by Hoffmann-La Roche: "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)".
Eligibility — raw, for validation
Inclusion Criteria: * 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 Exclusion Criteria: * 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