A Prospective, Observational, Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating AstraZeneca (or Alliance Developed) Drugs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 300
- 试验地点
- 71
- 主要终点
- Cohort A (resectable NSCLC)-Adjuvant rw DFS
研究概览
简要总结
This is an ambispective, observational, multicenter and multicohort study, targeting patients with NSCLC initiating approved drugs developed by AZ or as part of an AZ alliance, in the participating countries, as monotherapy or in combination at any stage of disease. Three cohorts are designed, based on the stage of NSCLC (resectable, unresectable and metastatic). The multicohort study is modular in design. Specific modules will be set up separately to assess each new indication of drugs developed by AZ or as part of an AZ alliance once European marketing authorization (MA) has been granted and made available in the participating countries.
Patients will be enrolled in the study if they have received (retrospective), receive (retrospective and prospective) or will receive (prospective) approved drugs developed by AZ or as part of an AZ alliance according to the eligibility criteria.
Treatment plan and decision are made independently by each treating physician prior to inclusion in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years old)
- •Patients with histologically or cytologically proven NSCLC
- •Patients initiated with approved drugs developed by AZ or as part of an AZ alliance at the time of the enrollment or within the previous three weeks.
- •Informed patients who consent to participate in the study as per local regulations.
排除标准
- •Patients participating in an interventional clinical trial for NSCLC*
- •* with the exception on low-interventional studies (RIPH2) where the intervention does not involve the NSCLC treatment
- •Patients already enrolled in another module of the cohort in UMBREALUNG
- •Patients under safeguard of justice, curatorship or guardianship
研究组 & 干预措施
Cohort 1 - Resectable
Ambispective, observational, study of patients with non-small cell lung cancer initiating approved drugs developed by AZ or as part of an AZ alliance in resectable NSCLC
Cohort 2 - Unresectable
Ambispective, observational, study of patients with non-small cell lung cancer initiating approved drugs developed by AZ or as part of an AZ alliance in Unresectable NSCLC
Cohort 3 - Metastatic
Ambispective, observational, study of patients with non-small cell lung cancer initiating approved drugs developed by AZ or as part of an AZ alliance in Metastatic NSCLC
结局指标
主要结局
Cohort A (resectable NSCLC)-Adjuvant rw DFS
时间窗: 3 years
wDFS is defined as the time from the index date (date of first administration of module specific approved drugs developed by AZ or as part of an AZ alliance) to the date of first investigator-determined recurrence (local or distant) or death (due to any cause), whichever occurs first. A patient who dies without reported recurrence will be considered to have recurred on the date of death. For patients who remain alive and whose disease has not recurred, DFS will be censored on the date of last evaluable disease assessment
Cohort A (resectable NSCLC)- Peri-operative rw EFS
时间窗: 3 years
rwEFS is defined as the time from the index date (date of first administration of module specific approved drugs developed by AZ or as part of an AZ alliance ) to the date of progression of the disease (PD) that precluded definitive surgery or discovered while attempting surgery, local or distant recurrence, or death (due to any cause), whichever occurs first. A patient who dies without reported recurrence will be considered to have event on the date of death. For patients who remain alive and who had no event, EFS will be censored on the date of last evaluable disease assessment
Cohort B (unresectable NSCLC): median rwTFST
时间窗: 3 years
real-world time to first subsequent systemic therapy (rwTFST) is defined as the time from the index date (date of first administration of module-specific approved drugs developed by AZ or as part of an AZ alliance ) to the date of first subsequent systemic therapy or the date of death (due to any cause). For patients still receiving the module-specific AZ approved drug at the end of follow-up, rwTFST will be censored on the last recorded day of ongoing treatment
Cohort C (metastatic NSCLC) rw TFST
时间窗: 3 years
real-world time to first subsequent systemic therapy (rwTFST) is defined as the time from the index date (date of first administration of module-specific approved drugs developed by AZ or as part of an AZ alliance ) to the date of first subsequent systemic therapy or the date of death (due to any cause). For patients still receiving the module-specific AZ approved drug at the end of follow-up, rwTFST will be censored on the last recorded day of ongoing treatment
次要结局
- Response rates - all cohorts(Response evaluation via patient's best response (PR, CR, SD, PD) and date of best response)
- Additional rw EFS (cohort A - Peri-operative)(rw EFS and rates at 6 months, 1y, 3y, 5y (rwEFS6m, rwEFS1y, rwEFS3y, rwEFS5y))
- rwPFS (cohort B and C)(Endpoints will be median real-world Progression Free Survival (rwPFS) and rates at 6, 12, 18, 24, 36 months and 5 years (rwPFS6m, rwPFS12m, rwPF18m, rwPFS24m, rwPFS36m, rwPFS5y))
- Additional rwDFS (Cohort A- adjuvant)(rwDFS and rates at 6 months, 1y, 3y, 5y (rwDFS6m, rwDFS1y, rwDFS3y, rwDFS5y))
- rwOS - all cohorts(rwOS and rates at 6, 12, 18, 24, 36 months and 5 years (rwOS6m, rwOS12m, rwOS18m, rwOS24m, rwOS3y,rwOS5y))
- rwPFS2 (all cohorts)(rwPFS2 and rates at 6, 12, 18, 24, 36 months and 5 years (rwPFS2-6m, rwPFS2-12m, rwPFS2-18m, rwD-RFS24m, rwPFS2-3y, rwPFS2-5y))
- Early progressors-rates and characteristics of patients - all cohorts(within 6 months)
- Real-word locoregional recurrence-free survival (rwL-RFS) - cohort A and B(rwL-RFS and rates at 6, 12, 18, 24, 36 months and 5 years (rwL-RFS6m, rwL-RFS12m, rwL-RFS18m, rwL-RFSm, rwL-RFS3y,rrwL-RFS5y))
- Real world time to treatment discontinuation (rwTTD) - all cohorts(3 or 5 years)
- rwD-RFS or rwD-PFS ( cohort A and B)(rwD-RFS and rates at 6, 12, 18, 24, 36 months and 5 years or rwD-PFS and rates at 6, 12, 18, 24, 36 months and 5 years)
- Real world time to first subsequent local treatment (rwTFST-local treatment) all cohorts(3 or 5 years)
- Real world time to next treatment (rwTTNT) - all cohorts(rwTTNT and rates at 6 months, 1y, 3y,5y (rwTTNT6m, rwTTNT1y, rwTTNT3y,rwTTNTS5y))
- rwTFST (systemic) - cohort A and B(3 or 5 years)
- Description of associated therapies(3 or 5 years)