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

NCT05834348 | Completed Results

• 2 other identifiers: B7461041DELINOR
• Study Type: observational
• Target: 5,279
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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

  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

  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

  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

  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

Study Arms (1)

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

Interventions

lorlatinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

crizotinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

brigatinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

ceritinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

alectinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

atezolizumab DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

bevacizumab DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

paclitaxel DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

carboplatin DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

docetaxel DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

erlotinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

gefitinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

afatinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

dacomitinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

osimertinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

pembrolizumab DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

nivolumab DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

entrectinib DRUG

As provided in real world practice

Advanced/metastatic non-small cell lung cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Norway

Oslo, Norway

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

lorlatinib; Crizotinib; brigatinib; ceritinib; alectinib; atezolizumab; Bevacizumab; Paclitaxel; Carboplatin; Docetaxel; Erlotinib Hydrochloride; Gefitinib; Afatinib; dacomitinib; osimertinib; pembrolizumab; Nivolumab; entrectinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 28, 2023
• Study Start: June 23, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: March 30, 2025
• Results First Posted: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)