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: Completed
• 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 (Actual): 5279

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • 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	Measure Description	Time Frame
Duration of Treatment of Anti-cancer Drugs	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.	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 According to Treatments of Anti-cancer Drugs	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.	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 According to Treatment Lines of Anti-cancer Drugs	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.	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
Overall Survival (OS)	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis	The percentage of participants classified according to the disease stages as 3B, 3C, 4A and 4B at the time of diagnosis were reported in this outcome measure. Cancer stages were classified based on tumor size (T), metastasis to nearby lymph nodes (LN) [N] and distant metastasis (M). Stages were 3B, 3C, 4A and 4B. Stage 3B (T1N3M0, T2N3M0, T3N3M0 and T4N2M0). Stage 3C (T3N3M0, T4N3M0), Stage 4A (anyT, anyM and M1a/M1b), Stage 4B (anyT, anyM and M1c). where T1=<3 cm; T2= 3 to <5 cm; T3= 5 to <7 cm; T4= >7cm. N0=not spread to LN; N1=spread to 1 to 3; N2=spread to 4 to 9; N3=spread >10 axillary LN. M0= no metastasis; M1a= cancer has spread to other lung; M1b= cancer has as a single tumor outside of the chest, such as to a distant lymph node or an organ such as the liver, bones, or brain; M1c= cancer has spread as more than one tumor outside the chest, such as to distant lymph nodes and/or to other organs such as the liver, bones, or brain.	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	Percentage of participants classified according to the NSCLC histopathological subtype viz adenocarcinoma, non-small cell carcinoma, large cell neuroendocrine carcinoma were reported in this outcome measure.	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
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs	Number of participants classified according to the selected administered non-cancer drugs (anticoagulants and statins) were reported in this outcome measure.	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	Number of packs dispensed to participants at the time of dispensing were reported in this outcome measure.	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	Number of participants classified according to the Norwegian health regions were reported in this outcome measure.	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

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 23, 2023
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): January 23, 2024

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 (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

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