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| ID | Type | Description | Link |
|---|---|---|---|
| DELINOR | Other Identifier | Alias Study Number |
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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:
The study is based on data collection from 3 national health registries:
Data from these registries will be linked at an individual patient level to create a single, unified dataset. The information collected includes:
Diagnosis, cancer stage at diagnosis, date of diagnosis, birth year, type of medicinal treatment, date of treatment start and end, treating hospital, age, gender, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced/metastatic non-small cell lung cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lorlatinib | Drug | As provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population are patients with advanced/metastatic non-small cell lung cancer in the Norwegian National cancer registry.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Norway | Oslo | Norway |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Biomarker Cohort | Participants with NSCLC who were positive for biomarkers (epidermal growth factor [EGFR] or anaplastic lymphoma kinase [ALK] or ROS proto-oncogene 1 [ROS1]) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2022 |
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| 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 |
|
| 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 |
| 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. | 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. | 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. | 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. | 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 |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at diagnosis reported. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | 95% Confidence Interval | Months | 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 |
|
|
| ||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | 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 |
| |||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | 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 |
| |||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Median | 95% Confidence Interval | Months | 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 | 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. | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Posted | Number | Percentage of participants | 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 |
| |||||||||||||||||||||||||||||||
| 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. | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Posted | Number | Percentage of participants | 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 |
|
| ||||||||||||||||||||||||||||||
| 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. | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Posted | Count of Participants | Participants | 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 |
|
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | 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 |
| |||||||||||||||||||||||||||||||
| 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. | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Posted | Count of Participants | Participants | 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 |
|
|
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
This study is retrospective, it involves data that exist as structured data by the time of study start. From data source, individual participant data were not retrieved or validated. The minimum criteria for reporting an adverse event (AE) (i.e., identifiable participant, identifiable reporter, a suspect product, and event) cannot be met. Hence, adverse events were not planned to be assessed and are not reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 364 | 618 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 3,780 | 4,661 | 0 | 0 | 0 | 0 |
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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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@pfizer.com |
| Jan 23, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000590786 | lorlatinib |
| D000077547 | Crizotinib |
| C000598580 | brigatinib |
| C586847 | ceritinib |
| C582670 | alectinib |
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| D000069347 | Erlotinib Hydrochloride |
| D000077156 | Gefitinib |
| D000077716 | Afatinib |
| C525726 | dacomitinib |
| C000596361 | osimertinib |
| C582435 | pembrolizumab |
| D000077594 | Nivolumab |
| C000607349 | entrectinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000577 | Amides |
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|
|
| EGFR+ participants receiving osimertinib: mTToT |
|
|
| EGFR+ participants receiving other TKI: mToT |
|
|
| EGFR+ participants receiving other TKI: mTToT |
|
|
| ALK+ participants receiving alectinib: mToT |
|
|
| ALK+ participants receiving alectinib: mTToT |
|
|
| ALK+ participants receiving brigatinib: mToT |
|
|
| ALK+ participants receiving brigatinib: mTToT |
|
|
| ALK+ participants receiving crizotinib: mToT |
|
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| ALK+ participants receiving crizotinib: mTToT |
|
|
| ROS1+ participants receiving crizotinib: mToT |
|
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| ROS1+ participants receiving crizotinib: mTToT |
|
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| Non-biomarker participants receiving crizotinib: mToT |
|
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| Non-biomarker participants receiving crizotinib: mTToT |
|
|
| Non-biomarker participants receiving erlotinib: mToT |
|
|
| Non-biomarker participants receiving erlotinib: mTToT |
|
|
|
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| Units | Counts |
|---|---|
| Participants |
|
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| Units | Counts |
|---|
| Participants |
|
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| OG001 |
| 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. |
|
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| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|