2023-504209-35-00招募中3 期
A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment with Atezolizumab or Placebo in Combination with Platinum-Based Chemotherapy in Patients With resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 207
- 试验地点
- 41
- 主要终点
- IRF-assessed EFS
研究概览
简要总结
To evaluate the efficacy of neoadjuvant treatment with atezolizumab in combination with platinum-based chemotherapy followed by adjuvant atezolizumab based on independent review facility (IRF) -assessed event-free survival (EFS)
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety follow-up
- 盲法
- None
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
- 是
入选标准
- •Age ≥ 18 years
- •Eligibility to receive a platinum-based chemotherapy regimen
- •Pathologically documented Stage II, IIIA, or select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology Staging should be based on the 8th edition of the American Joint Committee on Cancer / Union Internationale Contre le Cancer NSCLC staging system- T4 primary NSCLC will be allowed only on the basis of size (tumors > 7 cm).
- •Solid or subsolid appearance of NSCLC on CT scan with no appearance of purely ground-glass opacity (GGO)
- •Eligible for R0 resection with curative intent
- •Adequate pulmonary, cardiac, hematologic and end-organ function to be eligible for surgical resection with curative intent, as assessed by Pulmonary function tests (PFTs)
排除标准
- •Illness or condition that may interfere with a patient's capacity to understand, follow, and/or comply with study procedures
- •NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma
- •Mixed NSCLC and small cell lung cancer histology
- •Any prior therapy for lung cancer, including chemotherapy or radiotherapy
- •Major surgical procedure, other than for diagnosis, within 28 days prior to initiation of study treatment, or anticipation of need for non-protocol- -mandated major surgical procedure during the study
- •Activating mutation in the epidermal growth factor receptor (EGFR) or with an anaplastic lymphoma kinase (ALK) fusion oncogene
结局指标
主要结局
IRF-assessed EFS
IRF-assessed EFS
次要结局
- 1. IRF-assessed pCR
- 2. IRF-assessed MPR
- 3. MPR and pCR, as assessed by the investigator site pathology laboratory
- 4. Objective response by the investigator according to RECIST v1.1
- 5. OS
- 6. Investigator-assessed EFS
- 7. DFS as determined by the investigator
- 8. 2-year and 3-year OS, IRF assessed EFS and investigator-assessed EFS
- 9. Change from baseline in health-related quality of life (HRQoL) scores as assessed through use of the two-item global health status (GHS)/ QoL subscale (Questions 29 and 30) of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 at each assessment time point during the study through the completion of adjuvant treatment and observation follow up assessments
- 10. Occurrence and severity of adverse events, including serious adverse events and immune-related adverse events, with severity determined according to NCI CTCAE v5.0
- 11. Incidence and length of surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations
- 12. Serum concentration of atezolizumab at specified timepoints
- 13. Incidence of anti-drug antibodies (ADAs) against atezolizumab during the study
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (41)
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