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.
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.
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.
- Conditions
- Non-Small Cell Lung Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Advanced/metastatic non-small cell lung cancer patients | Not 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.
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
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
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
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)
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
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
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
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
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.
- First posted28 Apr 2023
- Study start23 Jun 2023
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Treatment Patterns and Effects for Metastatic Non-small Cell Lung Cancer Patients In NORway (DELINOR)
- ClinicalTrials.gov ID
- NCT05834348
- Acronym / sponsor ID
- DELINOR / B7461041
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,279 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Posted 30 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced/metastatic non-small cell lung cancer patients | – | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are patients with advanced/metastatic non-small cell lung cancer in the Norwegian National cancer registry.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lorlatinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| crizotinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| brigatinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| ceritinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| alectinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| atezolizumabAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| bevacizumabAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| paclitaxelAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| carboplatinAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| docetaxelAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| erlotinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| gefitinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| afatinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| dacomitinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| osimertinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| pembrolizumabAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| nivolumabAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
| entrectinibAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
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
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
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 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 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
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.