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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 90
- 主要终点
- 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
研究概览
简要总结
To compare the efficacy of divarasib compared with investigator’s choice of pembrolizumab, nivolumab, or observation with respect to disease free survival (DFS)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PEMBROLIZUMAB, PEMBROLIZUMAB
干预措施: PEMBROLIZUMAB (Drug)
NIVOLUMAB, NIVOLUMAB
干预措施: NIVOLUMAB (Drug)
RO 743-5846/F04, RO 743-5846/F07, RO7435846, RO7435846
干预措施: RO 743-5846/F04 (Drug)
RO 743-5846/F04, RO 743-5846/F07, RO7435846, RO7435846
干预措施: RO 743-5846/F07 (Drug)
RO 743-5846/F04, RO 743-5846/F07, RO7435846, RO7435846
干预措施: RO7435846 (Drug)
结局指标
主要结局
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
次要结局
- 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
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG