Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.
NCT04647110
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
-Inclusion criteria for ALK-positive NSCLC patients will be based on prescription data i.e. defines eligible patients as adult patients with at least one filled prescription of ALK-inhibitors identified by the national prescription register. Only prescriptions filled at pharmacies can be captured in prescription registers, as they do not include data on hospital drugs. ALK-inhibitor treatments for patients with NSCLC are given primarily outside of the hospital setting minimizing the selection bias under the inclusion criteria.
-not applicable
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Sollentuna,
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers. | ||||||
| Official Title | Real-world Study of Non-small Cell Lung Cancer Treatment With ALK-tyrosine Kinase Inhibitors (ALK TKI) in Sweden: Drug Sequencing, Treatment Duration and Overall Survival - A Retrospective Study Using Swedish Register Data | ||||||
| Brief Summary | This study aims to explore for the first time how the different ALK TKIs have been sequenced in real-world clinical practice and with which outcomes for Swedish lung cancer patients | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | Adult patients treated with ALK TKIs in Sweden between 2012 and 2019, identified via the national prescription register. | ||||||
| Condition | ALK-positive NSCLC | ||||||
| Intervention |
| ||||||
| Study Groups/Cohorts | Swedish Anaplastic lymphoma kinase (ALK) positive Non-small cell lung cancer (NSCLC) patients
Interventions:
| ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment | 500 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | March 31, 2021 | ||||||
| Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Inclusion Criteria: -Inclusion criteria for ALK-positive NSCLC patients will be based on prescription data i.e. defines eligible patients as adult patients with at least one filled prescription of ALK-inhibitors identified by the national prescription register. Only prescriptions filled at pharmacies can be captured in prescription registers, as they do not include data on hospital drugs. ALK-inhibitor treatments for patients with NSCLC are given primarily outside of the hospital setting minimizing the selection bias under the inclusion criteria. Exclusion Criteria: -not applicable | ||||||
| Sex/Gender |
| ||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
| ||||||
| Listed Location Countries | Sweden | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT04647110 | ||||||
| Other Study ID Numbers | B7461035 SEQUIA ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
| ||||||
| IPD Sharing Statement |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor | Pfizer | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | February 2021 | ||||||