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Non-Small Cell Lung CancerDELINORNCT05834348

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

An observational study of Non-Small Cell Lung Cancer, run by Pfizer at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
lorlatinib, crizotinib and brigatinib
How many people
5,279 participants
Where
1 siteNorway
Study dates
23 Jun 2023to 23 Jan 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Pfizer Norway

    Oslo

Other trials in Norway

About this study

Official title: 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:

Read more
  • 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.

Being tested
lorlatinib, crizotinib, brigatinib, ceritinib, alectinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lorlatinibDrug

    As provided in real world practice

  • crizotinibDrug

    As provided in real world practice

  • brigatinibDrug

    As provided in real world practice

  • ceritinibDrug

    As provided in real world practice

  • alectinibDrug

    As provided in real world practice

  • atezolizumabDrug

    As provided in real world practice

  • bevacizumabDrug

    As provided in real world practice

  • paclitaxelDrug

    As provided in real world practice

  • carboplatinDrug

    As provided in real world practice

  • docetaxelDrug

    As provided in real world practice

  • erlotinibDrug

    As provided in real world practice

  • gefitinibDrug

    As provided in real world practice

  • afatinibDrug

    As provided in real world practice

  • dacomitinibDrug

    As provided in real world practice

  • osimertinibDrug

    As provided in real world practice

  • pembrolizumabDrug

    As provided in real world practice

  • nivolumabDrug

    As provided in real world practice

  • entrectinibDrug

    As provided in real world practice

Study groups in NCT05834348
Study groupRoleWhat they receive
Advanced/metastatic non-small cell lung cancer patientsNot described
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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 outcomes (5)
  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2023
  2. Study start23 Jun 2023
  3. Primary completion23 Jan 2024
  4. Study completion23 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
5,279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05834348
Sponsor's protocol ID
B7461041
Other IDs
DELINOR
Acronym
DELINOR
Status last verified
Mar 2025
First submitted
17 Apr 2023
Last updated
30 Mar 2025
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Small Cell Lung Cancer, run by Pfizer at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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