Clinical trial NCT04647110: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ALK-positive NSCLC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-11-30
Enrollment: 549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients treated with ALK TKIs in Sweden between 2012 and 2019, identified via the national prescription register.

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


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

Primary outcomes:
measure: Overall Survival (OS): Based on Treatment Cohort Groups
timeFrame: 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)
measure: Overall Survival: Based on Chemotherapy Status
timeFrame: 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)
measure: Overall Survival: Based on Central Nervous System (CNS) Metastases Status
timeFrame: 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)
measure: Overall Survival: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
timeFrame: 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)
measure: Overall Survival: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
timeFrame: 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)
measure: Overall Survival: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
timeFrame: 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)
measure: Overall Survival: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment
timeFrame: 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)
measure: Percentage of Participants Alive After 5 Years From Index Date: Based on Treatment Cohort Groups
timeFrame: 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 5 Years From Index Date: Based on Chemotherapy Status
timeFrame: 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 5 Years From Index Date: Based on CNS Metastases Status
timeFrame: 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
timeFrame: 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
timeFrame: 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
timeFrame: 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: 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
timeFrame: 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 6 Years From Index Date: Based on Treatment Cohort Groups
timeFrame: 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 6 Years From Index Date: Based on Chemotherapy Status
timeFrame: 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 6 Years From Index Date: Based on CNS Metastases Status
timeFrame: 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
timeFrame: 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
timeFrame: 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
timeFrame: 6 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months)
measure: 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
timeFrame: 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:
measure: Duration of Treatment: Based on Treatment Cohort Groups
timeFrame: 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)
measure: Duration of Treatment: Based on Chemotherapy Status
timeFrame: 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)
measure: Duration of Treatment: Based on ALK Sequencing, 1 Line of ALK TKI Treatment
timeFrame: 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)
measure: Duration of Treatment: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment
timeFrame: 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)
measure: Duration of Treatment: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment
timeFrame: 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)
measure: Duration of Treatment: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment
timeFrame: 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)
Other outcomes:
Locations:
city: Sollentuna
country: Sweden
facility: Pfizer Innovations AB
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: