N/A N=549

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.

ALK-positive NSCLC

Bottom Line

View on ClinicalTrials.gov: NCT04647110 ↗

Enrolled (actual)

549

Serious AEs

—

Results posted

Jul 2022

Primary outcome: Primary: Overall Survival (OS): Based on Treatment Cohort Groups — 1.94; 2.30; 4.56; 2.94 Years

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: crizotinib (Drug); alectinib (Drug); brigatinib (Drug); ceritinib (Drug); lorlatinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS): Based on Treatment Cohort Groups	1.94; 2.30; 4.56; 2.94; NA; 5.41	—
PRIMARY Overall Survival: Based on Chemotherapy Status	2.02; 1.44	—
PRIMARY Overall Survival: Based on Central Nervous System (CNS) Metastases Status	1.94; 0.61	—
PRIMARY Overall Survival: Based on ALK Sequencing, 1 Line of ALK TKI Treatment	0.88; NA; NA; 0.63; NA; 0.59	—
PRIMARY Overall Survival: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment	NA; 1.27; NA; NA; NA; NA	—
PRIMARY Overall Survival: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment	5.41; NA; 2.78; NA; NA; NA	—
PRIMARY Overall Survival: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment	5.49; 5.27	—
PRIMARY Percentage of Participants Alive After 5 Years From Index Date: Based on Treatment Cohort Groups	6.25; 9.52; 40.00; 50.00; 66.67; 100	—
PRIMARY Percentage of Participants Alive After 5 Years From Index Date: Based on Chemotherapy Status	16.39; 16.39	—
PRIMARY Percentage of Participants Alive After 5 Years From Index Date: Based on CNS Metastases Status	17.24; 0.00	—
PRIMARY Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 1 Line of ALK TKI Treatment	11.43; 0.00	—
PRIMARY Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment	66.67; 0.00; 0.00; 7.14	—
PRIMARY Percentage of Participants Alive After 5 Years From Index Date: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment	100.00; 50.00; 25.00	—
PRIMARY 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	100.00; 100.00	—
PRIMARY Percentage of Participants Alive After 6 Years From Index Date: Based on Treatment Cohort Groups	0.00; 0.00; 0.00; 0.00	—
PRIMARY Percentage of Participants Alive After 6 Years From Index Date: Based on Chemotherapy Status	10.00; 3.85	—
PRIMARY Percentage of Participants Alive After 6 Years From Index Date: Based on CNS Metastases Status	6.82; 0.00	—
PRIMARY Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 1 Line of ALK TKI Treatment	12.50; 0.00	—
PRIMARY Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment	0.00; 0.00; 0.00	—
PRIMARY Percentage of Participants Alive After 6 Years From Index Date: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment	0.00	—
PRIMARY 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	0.00; 33.33	—
SECONDARY Duration of Treatment: Based on Treatment Cohort Groups	1.66; 1.86; 3.37; 2.45; 2.56; 2.72	—
SECONDARY Duration of Treatment: Based on Chemotherapy Status	1.23; 1.07	—
SECONDARY Duration of Treatment: Based on ALK Sequencing, 1 Line of ALK TKI Treatment	0.72; 0.92; NA; 0.50; 0.80; 1.01	—
SECONDARY Duration of Treatment: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment	1.01; 0.62; 0.61; 0.95; NA; NA	—
SECONDARY Duration of Treatment: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment	1.12; NA; 0.70; NA; NA; NA	—
SECONDARY Duration of Treatment: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment	1.09; 1.56; 1.01; 0.73; 0.80; 0.63	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04647110). 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.