DELINOR: A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.
Study Details
Study Description
Brief Summary
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:
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Are 18 years of age or older.
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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:
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The Cancer Registry of Norway (CRN),
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The Norwegian Patient Registry (NPR),
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Advanced/metastatic non-small cell lung cancer patients
|
Drug: lorlatinib
As provided in real world practice
Drug: crizotinib
As provided in real world practice
Drug: brigatinib
As provided in real world practice
Drug: ceritinib
As provided in real world practice
Drug: alectinib
As provided in real world practice
Drug: atezolizumab
As provided in real world practice
Drug: bevacizumab
As provided in real world practice
Drug: paclitaxel
As provided in real world practice
Drug: carboplatin
As provided in real world practice
Drug: docetaxel
As provided in real world practice
Drug: erlotinib
As provided in real world practice
Drug: gefitinib
As provided in real world practice
Drug: afatinib
As provided in real world practice
Drug: dacomitinib
As provided in real world practice
Drug: osimertinib
As provided in real world practice
Drug: pembrolizumab
As provided in real world practice
Drug: nivolumab
As provided in real world practice
Drug: entrectinib
As provided in real world practice
|
Outcome Measures
Primary Outcome Measures
- The time to treatment discontinuation (i.e., treatment length) of the different anti-cancer drugs [01.01.2009 to 31.12.2022]
- Number and proportion of patients receiving different drug treatments and the sequence of these drugs (i.e., treatment lines). [01.01.2009 to 31.12.2022]
- Overall survival [01.01.2009 to 31.12.2022]
Secondary Outcome Measures
- Number of patients by disease stage at time of diagnosis [01.01.2009 to 31.12.2022]
- Number of patients According to NSCLC Histopathological Subtype [01.01.2009 to 31.12.2022]
- Number and proportion of patients receiving selected patient administered non-cancer drugs [01.01.2009 to 31.12.2022]
- Proportion of prescriptions lasting for 1, 2, 3, or more than 3 months for selected cancer drugs [01.01.2009 to 31.12.2022]
- Number of patients identified by specific Norwegian health regions [01.01.2009 to 31.12.2022]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients ≥ 18 years old with histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC at the time of diagnosis
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Received their first NSCLC diagnosis (stage IIIb, IIIc, IVa, or IVb) between 01 January 2009, and latest available year
Exclusion Criteria:
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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
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Norway | Oslo | Norway |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B7461041
- DELINOR