Drug Treatment Patterns and Effects for Metastatic Non-small Cell Lung Cancer Patients In NORway (DELINOR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 5,279
- 试验地点
- 1
- 主要终点
- Duration of Treatment of Anti-cancer Drugs
研究概览
简要总结
The main purpose of the study is to learn about the effectiveness and treatment sequence of lung cancer medicines. This study is performed outside of clinical trials in Norway in patients with metastatic non-small cell lung cancer. Non-small cell lung cancer is a group of lung cancers named for the kinds of cells found in the cancer and how the cells look under a microscope. Metastasis is when the cancer cells spread to other parts of the body.
This study includes patient's data from the database who:
- Are 18 years of age or older.
- Are confirmed to have metastatic non-small cell lung cancer between 01 January 2009 and 31 December 2022.
The study is based on data collection from 3 national health registries:
- The Cancer Registry of Norway (CRN),
- The Norwegian Patient Registry (NPR),
- The Norwegian Drug Registry (NDR).
Data from these registries will be linked at an individual patient level to create a single, unified dataset. The information collected includes:
Diagnosis, cancer stage at diagnosis, date of diagnosis, birth year, type of medicinal treatment, date of treatment start and end, treating hospital, age, gender, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old with histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC at the time of diagnosis
- •Received their first NSCLC diagnosis (stage IIIb, IIIc, IVa, or IVb) between 01 January 2009, and latest available year
排除标准
- •Patients ≥ 18 years old with histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC at the time of diagnosis who received radiation therapy with curative intent, defined as a radiation dose larger than 50gy
- •If the data include patients diagnosed after 2021, IIIb patients will be excluded due to changes in the guideline. The updated guidelines for 2022 recommends that patients diagnosed with stage IIIb who have surgery with the intent to cure should not have ''curative'' radiation (i.e.: it is not possible to exclude these from the population from 2022).
研究组 & 干预措施
Advanced/metastatic non-small cell lung cancer patients
干预措施: lorlatinib (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: crizotinib (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: brigatinib (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: ceritinib (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: alectinib (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: atezolizumab (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: bevacizumab (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: paclitaxel (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: carboplatin (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: docetaxel (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: erlotinib (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: gefitinib (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: afatinib (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: dacomitinib (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: osimertinib (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: pembrolizumab (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: nivolumab (Drug)
Advanced/metastatic non-small cell lung cancer patients
干预措施: entrectinib (Drug)
结局指标
主要结局
Duration of Treatment of Anti-cancer Drugs
时间窗: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study
The duration of treatment of anti-cancer drugs was calculated as median time to treatment (mToT) for first line treatment and the median total ToT for all treatment lines (mTToT) for the anticancer therapies for EGFR+, ALK+ and ROS1+ and was presented in this outcome measure. mToT measured the time on the treatment participants receive as first line treatment, measuring the time from they start the treatment until they stop the first line treatment (or end of follow up), using the Kaplan Meier estimator. mTToT measured the time on all treatment - from the time they start first line treatment, until the point they stop their last treatment line (or end of follow up), using the Kaplan Meier estimator.
Number of Participants Classified According to Treatments of Anti-cancer Drugs
时间窗: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study
Number of participants were classified and reported according to the Anti-cancer drugs received during first-line, second-line and third-line treatment after diagnosis of NSCLC.
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
时间窗: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study
Number of participants were classified and reported according to the treatment lines received including first-line, second-line and third-line treatment after diagnosis of NSCLC.
Overall Survival (OS)
时间窗: From treatment initiation (1-Jan-2015) to date of death (until 31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study
OS was defined as time from treatment initiation of anticancer therapy to date of death due to any cause. Analysis was performed by Kaplan-Meier method.
次要结局
- Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs(From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study)
- Number of Packs Dispensed at the Time of Dispensing(From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study)
- Number of Participants Classified as Per Specific Norwegian Health Regions(At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study)
- Percentage of Participants Classified According to the NSCLC Histopathological Subtype(At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study)
- Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis(At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study)