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NCT Number: NCT05834348

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Norway

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lorlatinib

Drug

As provided in real world practice

Crizotinib

Drug

As provided in real world practice

Brigatinib

Drug

As provided in real world practice

Ceritinib

Drug

As provided in real world practice

Alectinib

Drug

As provided in real world practice

Atezolizumab

Drug

As provided in real world practice

Bevacizumab

Drug

As provided in real world practice

paclitaxel

Drug

As provided in real world practice

carboplatin

Drug

As provided in real world practice

docetaxel

Drug

As provided in real world practice

Erlotinib

Drug

As provided in real world practice

Gefitinib

Drug

As provided in real world practice

afatinib

Drug

As provided in real world practice

dacomitinib

Drug

As provided in real world practice

Osimertinib

Drug

As provided in real world practice

Pembrolizumab

Drug

As provided in real world practice

Nivolumab

Drug

As provided in real world practice

Entrectinib

Drug

As provided in real world practice

Primary outcomes

  1. Duration of Treatment of Anti-cancer Drugs

    Time frame: 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

    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.

  2. Number of Participants Classified According to Treatments of Anti-cancer Drugs

    Time frame: 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 were classified and reported according to the Anti-cancer drugs received during first-line, second-line and third-line treatment after diagnosis of NSCLC.

  3. Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs

    Time frame: 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 were classified and reported according to the treatment lines received including first-line, second-line and third-line treatment after diagnosis of NSCLC.

  4. Overall Survival (OS)

    Time frame: 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

    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.

Secondary outcomes

  1. Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis

    Time frame: 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

    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.

  2. Percentage of Participants Classified According to the NSCLC Histopathological Subtype

    Time frame: 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 viz adenocarcinoma, non-small cell carcinoma, large cell neuroendocrine carcinoma were reported in this outcome measure.

  3. Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs

    Time frame: 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 the selected administered non-cancer drugs (anticoagulants and statins) were reported in this outcome measure.

  4. Number of Packs Dispensed at the Time of Dispensing

    Time frame: 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 to participants at the time of dispensing were reported in this outcome measure.

  5. Number of Participants Classified as Per Specific Norwegian Health Regions

    Time frame: 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 Norwegian health regions were reported in this outcome measure.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: DELINOR

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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