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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05834348
Acronym
DELINOR
Enrollment
5279
Registered
2023-04-28
Start date
2023-06-23
Completion date
2024-01-23
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Brief 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.

Interventions

DRUGlorlatinib

As provided in real world practice

DRUGcrizotinib

As provided in real world practice

DRUGbrigatinib

As provided in real world practice

DRUGceritinib

As provided in real world practice

DRUGalectinib

As provided in real world practice

DRUGatezolizumab

As provided in real world practice

DRUGbevacizumab

As provided in real world practice

DRUGpaclitaxel

As provided in real world practice

DRUGcarboplatin

As provided in real world practice

DRUGdocetaxel

As provided in real world practice

DRUGerlotinib

As provided in real world practice

DRUGgefitinib

As provided in real world practice

DRUGafatinib

As provided in real world practice

DRUGdacomitinib

As provided in real world practice

DRUGosimertinib

As provided in real world practice

DRUGpembrolizumab

As provided in real world practice

DRUGnivolumab

As provided in real world practice

DRUGentrectinib

As provided in real world practice

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Duration of Treatment of Anti-cancer DrugsFrom 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 studyThe 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 DrugsFrom 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 studyNumber 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 DrugsFrom 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 studyNumber 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 studyOS 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

MeasureTime frameDescription
Percentage of Participants Classified According to the Disease Stage at the Time of DiagnosisAt time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational studyThe 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.
Number of Participants Classified as Per Specific Norwegian Health RegionsAt time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational studyNumber of participants classified according to the Norwegian health regions were reported in this outcome measure.
Percentage of Participants Classified According to the NSCLC Histopathological SubtypeAt time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational studyPercentage 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 DrugsFrom 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 studyNumber 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 DispensingFrom 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 studyNumber of packs dispensed to participants at the time of dispensing were reported in this outcome measure.

Countries

Norway

Participant flow

Recruitment details

Data of eligible participants with non-small cell lung cancer (NSCLC) with age greater than (\>) 18 years at the time of initiating anticancer therapy was collected retrospectively from the 3 national registries: Cancer Registry of Norway (CRN), the Norwegian Drug Registry (NDR) and the Norwegian Patient Registry (NPR) between 1-Jan-2015, and 31-Dec-2022 (maximum up to 96 months). The study was conducted in Norway.

Pre-assignment details

Available data was evaluated as per the study objectives, from 23-Jun-2023 to 23-Jan-2024 (approximately 7 months) in this retrospective observational study.

Participants by arm

ArmCount
Biomarker Cohort
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
618
Non-biomarker Cohort
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
4,661
Total5,279

Baseline characteristics

CharacteristicBiomarker CohortNon-biomarker CohortTotal
Age, Continuous67.1 Years
STANDARD_DEVIATION 13
70.7 Years
STANDARD_DEVIATION 9.7
70.2 Years
STANDARD_DEVIATION 10.2
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
385 Participants2158 Participants2543 Participants
Sex: Female, Male
Male
233 Participants2503 Participants2736 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
364 / 6183,780 / 4,661
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

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

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified rows.

ArmMeasureGroupValue (MEDIAN)
Biomarker CohortDuration of Treatment of Anti-cancer DrugsEGFR+ participants receiving other TKI: mTToT15.8 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsEGFR+ participants receiving osimertinib: mToT11 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsEGFR+ participants receiving osimertinib: mTToT14 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsEGFR+ participants receiving other TKI: mToT9.4 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsALK+ participants receiving alectinib: mToT20 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsALK+ participants receiving alectinib: mTToT28 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsALK+ participants receiving brigatinib: mToT11 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsALK+ participants receiving brigatinib: mTToT16 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsALK+ participants receiving crizotinib: mToT7 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsALK+ participants receiving crizotinib: mTToT19 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsROS1+ participants receiving crizotinib: mToT5 Months
Biomarker CohortDuration of Treatment of Anti-cancer DrugsROS1+ participants receiving crizotinib: mTToT18 Months
Non-biomarker CohortDuration of Treatment of Anti-cancer DrugsNon-biomarker participants receiving crizotinib: mToT3 Months
Non-biomarker CohortDuration of Treatment of Anti-cancer DrugsNon-biomarker participants receiving crizotinib: mTToT8.1 Months
Non-biomarker CohortDuration of Treatment of Anti-cancer DrugsNon-biomarker participants receiving erlotinib: mToT0.9 Months
Non-biomarker CohortDuration of Treatment of Anti-cancer DrugsNon-biomarker participants receiving erlotinib: mTToT6.3 Months
Primary

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.

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

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, Number Analyzed signifies number evaluable for specified rows. All participants under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsALK+: first line treatment115 Participants
Biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsALK+: second line treatment51 Participants
Biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsALK+: third line treatment20 Participants
Biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsROS1+: first line treatment22 Participants
Biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsROS1+: second line treatment6 Participants
Biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsEGFR+: first line treatment335 Participants
Biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsEGFR+: second line treatment139 Participants
Biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsEGFR+: third line treatment44 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsNon-biomarker: second line treatment58 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsNon-biomarker: third line treatment9 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatment Lines of Anti-cancer DrugsNon-biomarker: first line treatment2589 Participants
Primary

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.

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

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure; Number Analyzed signifies participants evaluable for specified rows. All participants under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving osimertinib in second line25 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving afatinib in second line22 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving brigatinib in first line21 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving alecitinib in second line14 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving crizotinib in second line4 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving other drugs in second line21 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving lorlatinib in third line6 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving alectinib in third line4 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving crizotinib in third line2 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving other drugs in third line8 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsROS1+ participants receiving IO/ChT in first line13 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsROS1+ participants receiving crizotinib in first line5 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving osimertinib in first line104 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving gefitinib in first line86 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving erlotinib in first line50 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving crizotinib in first line2 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving other drugs in first line93 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving IO and/or ChT in second line53 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving erlotinib in second line19 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving other drugs in second line20 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving IO and/or ChT in third line17 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving osimertinib in third line13 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving erlotinib in third line3 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsEGFR+ participants receiving other drugs in third line11 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving alecitinib in first line55 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving crizotinib in first line29 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving other drugs in first line10 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsALK+ participants receiving lorlatinib in second line12 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsROS1+ participants receiving other drugs in first line4 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsROS1+ participants receiving crizotinib in second line2 Participants
Biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsROS1+ participants receiving other drugs in second line4 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsNon-biomarker participants receiving crizotinib in first line23 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsNon-biomarker participants receiving erlotinib in first line26 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsNon-biomarker participants receiving IO/ChT in first line2540 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsNon-biomarker participants receiving crizotinib in second line7 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsNon-biomarker participants receiving erlotinib in second line13 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsNon-biomarker participants receiving IO/ChT in second line22 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsNon-biomarker participants receiving other drugs in second line16 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsNon-biomarker participants receiving erlotinib in third line1 Participants
Non-biomarker CohortNumber of Participants Classified According to Treatments of Anti-cancer DrugsNon-biomarker participants receiving other drugs in third line8 Participants
Primary

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.

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

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, Number Analyzed signifies number evaluable for specified rows. All participants under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row.

ArmMeasureGroupValue (MEDIAN)
Biomarker CohortOverall Survival (OS)ROS+ participants: 2015-2019NA Months
Biomarker CohortOverall Survival (OS)All participants: 2015-201919 Months
Biomarker CohortOverall Survival (OS)ALK+ participants: 2020-2022NA Months
Biomarker CohortOverall Survival (OS)ROS+ participants: 2020-2022NA Months
Biomarker CohortOverall Survival (OS)All participants: 2020-202223 Months
Biomarker CohortOverall Survival (OS)EGFR+ participants: 2015-201918 Months
Biomarker CohortOverall Survival (OS)EGFR+ participants: 2020-202223 Months
Biomarker CohortOverall Survival (OS)ALK+ participants: 2015-201924 Months
Non-biomarker CohortOverall Survival (OS)All participants: 2015-20195 Months
Non-biomarker CohortOverall Survival (OS)All participants: 2020-20227 Months
Secondary

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.

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

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified rows. All participants under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 3 packs at fourth dispensation3 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 4 packs or more at first dispensation0 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 4 packs or more at second dispensation0 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 4 packs or more at third dispensation0 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 4 packs or more at fourth dispensation0 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 1 pack at first dispensation131 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 1 pack at second dispensation102 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 1 pack at third dispensation86 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 1 pack at fourth dispensation74 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 2 packs at fourth dispensation21 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 3 packs at first dispensation5 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 3 packs at second dispensation6 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 3 packs at third dispensation9 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 3 packs at fourth dispensation4 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 4 packs or more at first dispensation0 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 4 packs or more at second dispensation1 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 4 packs or more at third dispensation1 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 4 packs or more at fourth dispensation1 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 1 pack at first dispensation65 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 1 pack at second dispensation61 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 1 pack at third dispensation57 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 1 pack at fourth dispensation44 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 2 packs at first dispensation4 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 2 packs at second dispensation3 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 2 packs at third dispensation4 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 2 packs at fourth dispensation9 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 3 packs at first dispensation3 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 3 packs at second dispensation5 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 3 packs at third dispensation5 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 3 packs at fourth dispensation2 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 4 packs or more at first dispensation0 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 4 packs or more at second dispensation0 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 4 packs or more at third dispensation0 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 4 packs or more at fourth dispensation0 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 1 pack at first dispensation41 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 1 pack at second dispensation31 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 2 packs at fourth dispensation4 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 3 packs at first dispensation8 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 3 packs at second dispensation7 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 3 packs at third dispensation4 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 3 packs at fourth dispensation7 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 1 pack at third dispensation21 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 1 pack at fourth dispensation19 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 2 packs at first dispensation2 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 2 packs at second dispensation4 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 2 packs at third dispensation6 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 1 pack at first dispensation71 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 1 pack at second dispensation64 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 1 pack at third dispensation51 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 1 pack at fourth dispensation49 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 2 packs at first dispensation1 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 2 packs at second dispensation3 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 2 packs at third dispensation9 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 2 packs at fourth dispensation8 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 3 packs at first dispensation1 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 3 packs at second dispensation2 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingAlectinib: 3 packs at third dispensation2 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 2 packs at first dispensation6 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 2 packs at second dispensation17 Participants
Biomarker CohortNumber of Packs Dispensed at the Time of DispensingOsimertinib: 2 packs at third dispensation18 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: <1 pack at first dispensation14 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: <1 pack at second dispensation1 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: <1 pack at third dispensation1 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 3 packs at second dispensation2 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 1 pack at third dispensation15 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 1 pack at first dispensation28 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 1 pack at fourth dispensation10 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 3 packs at third dispensation1 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 2 packs at first dispensation2 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 3 packs at third dispensation0 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 2 packs at second dispensation1 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: <1 pack at fourth dispensation0 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 2 packs at third dispensation2 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 3 packs at fourth dispensation0 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 1 pack at first dispensation23 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 1 pack at second dispensation24 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 1 pack at second dispensation15 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 4 packs or more at first dispensation0 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 1 pack at third dispensation7 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 3 packs at second dispensation0 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 1 pack at fourth dispensation5 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 4 packs or more at second dispensation0 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 2 packs at first dispensation2 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 2 packs at fourth dispensation1 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 2 packs at second dispensation3 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 4 packs or more at third dispensation1 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 2 packs at third dispensation1 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 3 packs at fourth dispensation0 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 2 packs at fourth dispensation1 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 4 packs or more at fourth dispensation1 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingErlotinib: 3 packs at first dispensation1 Participants
Non-biomarker CohortNumber of Packs Dispensed at the Time of DispensingCrizotinib: 3 packs at first dispensation0 Participants
Secondary

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.

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

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Enoxaparin79 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Combinations, acetylsalicylic acid0 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Dabigatran etexilate2 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Apixaban107 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Warfarin1 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Heparin6 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Dalteparin99 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Clopidogrel12 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Acetylsalicylic acid91 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Dipyridamole5 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Prasugrel1 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Ticagrelor2 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Rivaroxaban14 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Edoxaban15 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Fondaparinux0 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsStatin: Simvastatin47 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsStatin: Pravastatin10 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsStatin: Fluvastatin1 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsStatin: Atorvastatin97 Participants
Biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsStatin: Rosuvastatin11 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Fondaparinux2 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Enoxaparin523 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Ticagrelor14 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Dipyridamole41 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Combinations, acetylsalicylic acid48 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsStatin: Fluvastatin7 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Dabigatran etexilate28 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Rivaroxaban103 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Prasugrel8 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Apixaban498 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsStatin: Simvastatin375 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Warfarin33 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsStatin: Rosuvastatin59 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Heparin42 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsStatin: Pravastatin34 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Dalteparin659 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Edoxaban55 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Clopidogrel139 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsStatin: Atorvastatin646 Participants
Non-biomarker CohortNumber of Participants Classified According to the Selected Participant Administered Non-Cancer DrugsAnticoagulant: Acetylsalicylic acid843 Participants
Secondary

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.

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

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Biomarker CohortNumber of Participants Classified as Per Specific Norwegian Health RegionsNorthern Norway Regional Health Authority44 Participants
Biomarker CohortNumber of Participants Classified as Per Specific Norwegian Health RegionsWestern Norway Regional Health Authority156 Participants
Biomarker CohortNumber of Participants Classified as Per Specific Norwegian Health RegionsCentral Norway Regional Health Authority70 Participants
Biomarker CohortNumber of Participants Classified as Per Specific Norwegian Health RegionsUnknown7 Participants
Biomarker CohortNumber of Participants Classified as Per Specific Norwegian Health RegionsSouth-East Norway Regional Health Authority341 Participants
Non-biomarker CohortNumber of Participants Classified as Per Specific Norwegian Health RegionsUnknown26 Participants
Non-biomarker CohortNumber of Participants Classified as Per Specific Norwegian Health RegionsCentral Norway Regional Health Authority665 Participants
Non-biomarker CohortNumber of Participants Classified as Per Specific Norwegian Health RegionsNorthern Norway Regional Health Authority488 Participants
Non-biomarker CohortNumber of Participants Classified as Per Specific Norwegian Health RegionsSouth-East Norway Regional Health Authority2427 Participants
Non-biomarker CohortNumber of Participants Classified as Per Specific Norwegian Health RegionsWestern Norway Regional Health Authority1055 Participants
Secondary

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.

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

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.

ArmMeasureGroupValue (NUMBER)
Biomarker CohortPercentage of Participants Classified According to the Disease Stage at the Time of DiagnosisStage 4A36.2 Percentage of participants
Biomarker CohortPercentage of Participants Classified According to the Disease Stage at the Time of DiagnosisStage 3B3.5 Percentage of participants
Biomarker CohortPercentage of Participants Classified According to the Disease Stage at the Time of DiagnosisStage 3C1.6 Percentage of participants
Biomarker CohortPercentage of Participants Classified According to the Disease Stage at the Time of DiagnosisStage 4B58.6 Percentage of participants
Non-biomarker CohortPercentage of Participants Classified According to the Disease Stage at the Time of DiagnosisStage 3B5.6 Percentage of participants
Non-biomarker CohortPercentage of Participants Classified According to the Disease Stage at the Time of DiagnosisStage 4A36.2 Percentage of participants
Non-biomarker CohortPercentage of Participants Classified According to the Disease Stage at the Time of DiagnosisStage 4B55.1 Percentage of participants
Non-biomarker CohortPercentage of Participants Classified According to the Disease Stage at the Time of DiagnosisStage 3C3.1 Percentage of participants
Secondary

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.

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

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.

ArmMeasureGroupValue (NUMBER)
Biomarker CohortPercentage of Participants Classified According to the NSCLC Histopathological SubtypeAdenocarcinoma94.7 Percentage of participants
Biomarker CohortPercentage of Participants Classified According to the NSCLC Histopathological SubtypeNon-small cell carcinoma5.0 Percentage of participants
Biomarker CohortPercentage of Participants Classified According to the NSCLC Histopathological SubtypeLarge cell neuroendocrine carcinoma0.3 Percentage of participants
Non-biomarker CohortPercentage of Participants Classified According to the NSCLC Histopathological SubtypeAdenocarcinoma80.8 Percentage of participants
Non-biomarker CohortPercentage of Participants Classified According to the NSCLC Histopathological SubtypeNon-small cell carcinoma16.8 Percentage of participants
Non-biomarker CohortPercentage of Participants Classified According to the NSCLC Histopathological SubtypeLarge cell neuroendocrine carcinoma2.4 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026