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

Non-Small Cell Lung Cancer Clinical Trial

— DELINOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834348
• Other study ID #: B7461041
• Secondary ID: DELINOR
• Status: Recruiting
• Start date: June 26, 2023
• Est. completion date: February 3, 2025

Study information

• Verified date: October 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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:

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20605
• Est. completion date: February 3, 2025
• Est. primary completion date: February 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Patients = 18 years old with histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC at the time of diagnosis

2. Received their first NSCLC diagnosis (stage IIIb, IIIc, IVa, or IVb) between 01 January 2009, and latest available year

Exclusion Criteria:

1. 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

2. 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).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• lorlatinib
As provided in real world practice
• crizotinib
As provided in real world practice
• brigatinib
As provided in real world practice
• ceritinib
As provided in real world practice
• alectinib
As provided in real world practice
• atezolizumab
As provided in real world practice
• bevacizumab
As provided in real world practice
• paclitaxel
As provided in real world practice
• carboplatin
As provided in real world practice
• docetaxel
As provided in real world practice
• erlotinib
As provided in real world practice
• gefitinib
As provided in real world practice
• afatinib
As provided in real world practice
• dacomitinib
As provided in real world practice
• osimertinib
As provided in real world practice
• pembrolizumab
As provided in real world practice
• nivolumab
As provided in real world practice
• entrectinib
As provided in real world practice

Locations

Country	Name	City	State
Norway	Pfizer Norway	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to treatment discontinuation (i.e., treatment length) of the different anti-cancer drugs		01.01.2009 to 31.12.2022
Primary	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
Primary	Overall survival		01.01.2009 to 31.12.2022
Secondary	Number of patients by disease stage at time of diagnosis		01.01.2009 to 31.12.2022
Secondary	Number of patients According to NSCLC Histopathological Subtype		01.01.2009 to 31.12.2022
Secondary	Number and proportion of patients receiving selected patient administered non-cancer drugs		01.01.2009 to 31.12.2022
Secondary	Proportion of prescriptions lasting for 1, 2, 3, or more than 3 months for selected cancer drugs		01.01.2009 to 31.12.2022
Secondary	Number of patients identified by specific Norwegian health regions		01.01.2009 to 31.12.2022

External Links

•   To obtain contact information for a study center near you, click here.