N/A
N=5,279
A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05834348 ↗Enrolled (actual)
5,279
Serious AEs
—
Results posted
Mar 2025
Primary outcome: Primary: Duration of Treatment of Anti-cancer Drugs — 11; 14; 9.4; 15.8 Months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 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 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Treatment of Anti-cancer Drugs |
11; 14; 9.4; 15.8; 20; 28 | — |
| PRIMARY Number of Participants Classified According to Treatments of Anti-cancer Drugs |
104; 86; 50; 2; 93; 53 | — |
| PRIMARY Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs |
335; 139; 44; 115; 51; 20 | — |
| PRIMARY Overall Survival (OS) |
19; 5; 23; 7; 18; 23 | — |
| SECONDARY Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis |
3.5; 5.6; 1.6; 3.1; 36.2; 36.2 | — |
| SECONDARY Percentage of Participants Classified According to the NSCLC Histopathological Subtype |
94.7; 80.8; 5.0; 16.8; 0.3; 2.4 | — |
| SECONDARY Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs |
1; 33; 6; 42; 99; 659 | — |
| SECONDARY Number of Packs Dispensed at the Time of Dispensing |
71; 64; 51; 49; 1; 3 | — |
| SECONDARY Number of Participants Classified as Per Specific Norwegian Health Regions |
70; 665; 44; 488; 341; 2427 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT05834348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.