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.
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
2 other identifiers
observational
549
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2020
CompletedFirst Posted
Study publicly available on registry
November 30, 2020
CompletedStudy Start
First participant enrolled
December 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2021
CompletedResults Posted
Study results publicly available
July 13, 2022
CompletedApril 6, 2023
April 1, 2023
3 months
November 25, 2020
March 14, 2022
April 4, 2023
Conditions
Outcome Measures
Primary Outcomes (21)
Overall Survival (OS): Based on Treatment Cohort Groups
OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.
From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Overall Survival: Based on Chemotherapy Status
OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. Results were reported based on chemotherapy status.
From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Overall Survival: Based on Central Nervous System (CNS) Metastases Status
OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, participants were grouped on basis of their CNS-metastases status.
From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Overall Survival: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, OS was reported for participants who received 1 line of ALK TKI treatment. Reporting arms were based on type of ALK TKI, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.
From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Overall Survival: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure OS was reported for participants who received 2 lines of ALK TKI treatment. Reporting arms were based on type of first line ALK TKI treatment and second line of ALK TKI treatment, with or without chemotherapy.
From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Overall Survival: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure OS was reported for participants who received 3 lines of ALK inhibitor treatment. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment and third line of ALK TKI treatment with or without, chemotherapy.
From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Overall Survival: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment
OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, OS was reported for participants who received \>=4 lines of ALK inhibitor treatment with or without chemotherapy.
From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 5 Years From Index Date: Based on Treatment Cohort Groups
Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.
5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 5 Years From Index Date: Based on Chemotherapy Status
Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on chemotherapy status.
5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 5 Years From Index Date: Based on CNS Metastases Status
Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on CNS metastases status.
5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 1 line of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.
5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 2 lines of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment and second line of ALK TKI treatment, with or without chemotherapy.
5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 3 lines of ALK TKI treatment. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment, and third line of ALK TKI treatment, with or without chemotherapy.
5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment
Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, data is reported for participants who received \>=4 lines of ALK inhibitor treatment with or without chemotherapy.
5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 6 Years From Index Date: Based on Treatment Cohort Groups
Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI.
6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 6 Years From Index Date: Based on Chemotherapy Status
Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on chemotherapy status.
6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 6 Years From Index Date: Based on CNS Metastases Status
Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on CNS metastases status.
6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 1 line of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib.
6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, participants who received 2 lines of ALK TKI treatment, were reported. Reporting arms were based on type of first line ALK TKI treatment and second line of ALK TKI treatment, with or without chemotherapy.
6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure OS was reported for participants who received 3 lines of ALK inhibitor treatment. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment, and third line of ALK TKI treatment, with or without chemotherapy.
6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment
Participants alive after six years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported. In this outcome measure, data is reported for participants who received \>=4 lines of ALK inhibitor treatment with or without chemotherapy.
6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Secondary Outcomes (6)
Duration of Treatment: Based on Treatment Cohort Groups
From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Duration of Treatment: Based on Chemotherapy Status
From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Duration of Treatment: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Duration of Treatment: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
Duration of Treatment: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
- +1 more secondary outcomes
Study Arms (1)
Swedish Anaplastic lymphoma kinase (ALK) positive Non-small cell lung cancer (NSCLC) patients
Interventions
as provided in real world practice
as provided in real world practice
as provided in real world practice
as provided in real world practice
as provided in real world practice
Eligibility Criteria
Adult patients treated with ALK TKIs in Sweden between 2012 and 2019, identified via the national prescription register.
You may not qualify if:
- not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Innovations AB
Sollentuna, 19190, Sweden
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to ethical compliance study team ensured results would not be reported for those cohorts/groups which had less than 5 participants at the index date.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2020
First Posted
November 30, 2020
Study Start
December 14, 2020
Primary Completion
March 15, 2021
Study Completion
March 15, 2021
Last Updated
April 6, 2023
Results First Posted
July 13, 2022
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
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.