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

Last updated date
Study Location
Pfizer Innovations AB
Sollentuna, , 19190, Sweden
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ALK-positive NSCLC
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

-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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


-not applicable

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Advanced Information
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
  • Drug: crizotinib
    as provided in real world practice
  • Drug: alectinib
    as provided in real world practice
  • Drug: brigatinib
    as provided in real world practice
  • Drug: ceritinib
    as provided in real world practice
  • Drug: lorlatinib
    as provided in real world practice
Study Groups/Cohorts Swedish Anaplastic lymphoma kinase (ALK) positive Non-small cell lung cancer (NSCLC) patients
Interventions:
  • Drug: crizotinib
  • Drug: alectinib
  • Drug: brigatinib
  • Drug: ceritinib
  • Drug: lorlatinib
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
 (submitted: November 25, 2020)
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
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2021