A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Study Overview
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Brief Summary
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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.

Official Title
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Drug Treatment Patterns and Effects for Metastatic Non-small Cell Lung Cancer Patients In NORway (DELINOR)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: lorlatinib
* Drug: crizotinib
* Drug: brigatinib
* Drug: ceritinib
* Drug: alectinib
* Drug: atezolizumab
* Drug: bevacizumab
* Drug: paclitaxel
* Drug: carboplatin
* Drug: docetaxel
* Drug: erlotinib
* Drug: gefitinib
* Drug: afatinib
* Drug: dacomitinib
* Drug: osimertinib
* Drug: pembrolizumab
* Drug: nivolumab
* Drug: entrectinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced/metastatic non-small cell lung cancer patients<br> | Drug: lorlatinib<br>* As provided in real world practice<br>Drug: crizotinib<br>* As provided in real world practice<br>Drug: brigatinib<br>* As provided in real world practice<br>Drug: ceritinib<br>* As provided in real world practice<br>Drug: alectinib<br>* As provided in real world practice<br>Drug: atezolizumab<br>* As provided in real world practice<br>Drug: bevacizumab<br>* As provided in real world practice<br>Drug: paclitaxel<br>* As provided in real world practice<br>Drug: carboplatin<br>* As provided in real world practice<br>Drug: docetaxel<br>* As provided in real world practice<br>Drug: erlotinib<br>* As provided in real world practice<br>Drug: gefitinib<br>* As provided in real world practice<br>Drug: afatinib<br>* As provided in real world practice<br>Drug: dacomitinib<br>* As provided in real world practice<br>Drug: osimertinib<br>* As provided in real world practice<br>Drug: pembrolizumab<br>* As provided in real world practice<br>Drug: nivolumab<br>* As provided in real world practice<br>Drug: entrectinib<br>* As provided in real world practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |