A Phase I-III, Multicenter Study Evaluating The Efficacy And Safety Of Multiple Therapies In Cohorts Of Patients Selected According To Biomarker Status, With locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 试验地点
- 5
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Study BO42777 is a Phase I-III, global, multicenter, multicohort study to evaluate the efficacy and safety of multiple therapies in patients with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status. This population is based on the Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system. Patients with tumors harboring a cohort-eligible biomarker identified through one of the methods specified as follows will be screened for enrollment in the applicable cohort of this study. This platform trial evaluates several investigational medicinal products (IMPs) in biomarker-selected populations; each study treatment is evaluated independently. The cohorts contribute to the overarching hypothesis of the study by evaluating therapies in biomarker-selected, locally advanced, unresectable, Stage III non-small cell lung cancerAn independent data monitoring committee (iDMC) will be used to evaluate interim safety data on a regular basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Body weight 30 kg at screening Willingness and ability to use the electronic device or application for the electronic patient-reported outcome Whole-body positron emission tomography computed tomography scan from the base of skull to mid-thighs for the purposes of staging, performed prior and within 42 days of the first dose of cCRT or sCRT Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology Prior receipt of at least two prior cycles of platinum-based chemotherapy given concurrently with radiotherapy; or at least two prior cycles of platinum-based chemotherapy given prior to radiotherapy The RT component in the cCRT or sCRT must have been at a total dose of radiation of 60Gy administered by intensity-modulated radiotherapy (preferred) or three dimension conforming technique No disease progression during or following platinum-based cCRT or sCRT Life expectancy 12 weeks.
排除标准
- •Any history of previous NSCLC and or any history of prior treatment for NSCLC Any evidence of Stage IV disease, including, but not limited to, the following pleural effusion, pericardial effusion, brain metastases, history of intracranial hemorrhage or spinal cord hemorrhage, bone metastases, distant metastases NSCLC known to have a known or likely oncogenic-driver mutation in the EGFR gene, as identified by site local testing or Sponsor central testing Positive hepatitis B surface antigen test at screening.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From randomization to the first documented disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criterial in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurs first (up to 3 years)
次要结局
- Proportion of participants who have maintained or improved baseline health as measured by the European Organisation for the Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 physical functioning and role functioning scales(5, 11, and 17 months)
- Proportion of participants who have maintained or improved from their baseline health in cough, chest pain, and dyspnea symptoms as measured using the EORTC QLQ-LC13(5, 11, and 17 months)
- Percentage of participants with adverse events (AEs)(Up to 3 years)
- Time-to-confirmed deterioration (TTCD)(From randomization to the first deterioration of 10 points that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks (up to 3 years))
- Overall survival(From randomization to death from any cause (up to 5 years))