Drug Treatment Patterns and Effects for Metastatic Non-small Cell Lung Cancer Patients In NORway (DELINOR)
| Registry | NCT05834348, acronym DELINOR |
|---|
| Status | Completed |
|---|
| Study type | Observational |
|---|
| Enrollment | 5279 (Actual) |
|---|
| Sponsor | Pfizer (Industry) |
|---|
| Conditions | Non-Small Cell Lung Cancer |
|---|
| Interventions | lorlatinib, crizotinib, brigatinib, ceritinib, alectinib, atezolizumab, bevacizumab, paclitaxel, carboplatin, docetaxel, erlotinib, gefitinib, afatinib, dacomitinib, osimertinib, pembrolizumab, nivolumab, entrectinib (Drug) |
|---|
| Dates | start 2023-06-23, primary completion 2024-01-23, completion 2024-01-23, first posted 2023-04-28, last updated 2025-03-30 |
|---|
| Locations | 1 site in Norway |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Non-Small Cell Lung Cancer All trials of lorlatinib All trials of crizotinib
-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. 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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| 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 | |
- 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
+Outcome measures
Primary outcomes
- Duration of Treatment of Anti-cancer Drugs [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 [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 [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) [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
- Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis [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.
- Percentage of Participants Classified According to the NSCLC Histopathological Subtype [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.
- Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs [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.
- Number of Packs Dispensed at the Time of Dispensing [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.
- Number of Participants Classified as Per Specific Norwegian Health Regions [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.
+Eligibility
Sex: All, ages: 18 Years to any
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).
+Posted results
Participant flow
| Milestone | Biomarker Cohort | Non-biomarker Cohort |
|---|
| Started | 618 | 4661 |
| Completed | 618 | 4661 |
| Not completed | 0 | 0 |
Outcome results
- Duration of Treatment of Anti-cancer Drugs (Primary), Median, Months: Biomarker Cohort 11 (10.1 to NA); Non-biomarker Cohort
- Number of Participants Classified According to Treatments of Anti-cancer Drugs (Primary), Count of participants, Participants: Biomarker Cohort 104; Non-biomarker Cohort
- Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs (Primary), Count of participants, Participants: Biomarker Cohort 335; Non-biomarker Cohort
- Overall Survival (OS) (Primary), Median, Months: Biomarker Cohort 19 (16.5 to 21.2); Non-biomarker Cohort 5 (4.9 to 5.8)
- Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis (Secondary), Number, Percentage of participants: Biomarker Cohort 3.5; Non-biomarker Cohort 5.6
- Percentage of Participants Classified According to the NSCLC Histopathological Subtype (Secondary), Number, Percentage of participants: Biomarker Cohort 94.7; Non-biomarker Cohort 80.8
- Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs (Secondary), Count of participants, Participants: Biomarker Cohort 1; Non-biomarker Cohort 33
- Number of Packs Dispensed at the Time of Dispensing (Secondary), Count of participants, Participants: Biomarker Cohort 71; Non-biomarker Cohort
- Number of Participants Classified as Per Specific Norwegian Health Regions (Secondary), Count of participants, Participants: Biomarker Cohort 70; Non-biomarker Cohort 665
Adverse events
Time frame: All-cause mortality: 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. For adverse events it was not applicable as adverse event data was not planned to be assessed
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Biomarker Cohort | 364/618 (58.9%) | 0 | 0 |
| Non-biomarker Cohort | 3780/4661 (81.1%) | 0 | 0 |
Limitations and caveats: The observation period was changed from 1-Jan-2009 to 1-Jan-2015 based on sponsor decision as only a few participants with uncertain about the data quality were recorded prior 2015.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Pfizer Norway | Oslo | Norway | |
+Study documents
+Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer