A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB COMPARED WITH INVESTIGATOR’S CHOICE OF IMMUNOTHERAPY OR OBSERVATION IN PATIENTS WITH RESECTED STAGE II-III KRAS G12C-POSITIVE NON-SMALL CELL LUNG CANCER
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- F. Hoffmann-La Roche AG
- Enrollment
- 198
- Locations
- 90
- Primary Endpoint
- DFS defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
Study Overview
Brief Summary
To compare the efficacy of divarasib compared with investigator’s choice of pembrolizumab, nivolumab, or observation with respect to disease free survival (DFS)
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Documentation of the presence of a KRAS G12C mutation
- •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
- •No evidence of disease recurrence or metastatic disease
Exclusion Criteria
- •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
- •Participants who achieve pCR following neoadjuvant treatment
- •Resolved Grade 3 or greater immune-related adverse event or unresolved Grade 2 or greater immune-related adverse event from neoadjuvant immunotherapy
- •Treatment with a live, attenuated vaccine within 4 weeks prior to randomization, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment
Arms & Interventions
PEMBROLIZUMAB, PEMBROLIZUMAB
Intervention: PEMBROLIZUMAB (Drug)
NIVOLUMAB, NIVOLUMAB
Intervention: NIVOLUMAB (Drug)
RO 743-5846/F04, RO 743-5846/F07, RO7435846, RO7435846
Intervention: RO 743-5846/F04 (Drug)
RO 743-5846/F04, RO 743-5846/F07, RO7435846, RO7435846
Intervention: RO 743-5846/F07 (Drug)
RO 743-5846/F04, RO 743-5846/F07, RO7435846, RO7435846
Intervention: RO7435846 (Drug)
Outcomes
Primary Outcomes
DFS defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
DFS defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
Secondary Outcomes
- Overall Survival (OS) defined as the time from randomization to death from any cause
- 2-year and 3-year DFS rates as assessed by the investigator
- Incidence and severity of adverse events, including, but not limited to treatment emergent adverse events, serious adverse events, and deaths
Investigators
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG