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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Estimated): 20605

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Pfizer Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population are patients with advanced/metastatic non-small cell lung cancer in the Norwegian National cancer registry.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): February 3, 2025
• Study Completion (Estimated): February 3, 2025

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Docetaxel; Carboplatin; Nivolumab; Gefitinib; Osimertinib; Bevacizumab; Pembrolizumab; Atezolizumab; Afatinib; Crizotinib; Entrectinib; Ceritinib
• Other Study ID Numbers: B7461041; DELINOR (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.