NCT04351334

Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns

Completed Results posted Last updated 19 September 2024

What this trial tests

trial testing Alectinib in Non-Small-Cell Lung Carcinoma in 161 participants. Completed in 1 November 2022.

Timeline

1 March 2020

Primary endpoint
1 November 2022

1 November 2022

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	161
Start date	1 March 2020
Primary completion	1 November 2022
Estimated completion	1 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Alectinib — full drug profile →

Conditions studied

• Non-Small-Cell Lung Carcinoma — all drugs for Non-Small-Cell Lung Carcinoma →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Non-Small-Cell Lung Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence Primary · During the inclusion period from 01-Jun-2017 to 31-Aug-2020 (maximum up to 39 months); eligible data was studied during approximately 31 months of this retrospective study

Number of participants classified according to ALK-TKI treatment patterns or sequencing were reported in this outcome measure.

Group	Value	95% CI
All Eligible Participants	103
All Eligible Participants	8
All Eligible Participants	23
All Eligible Participants	1

Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation Primary · From initiation of index treatment to discontinuation from 01-Jun-2017 to 31-Aug-2021 (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study

Number of participants classified according to reason for Alectinib treatment discontinuation were reported in this outcome measure. One participant could have more than one reason for discontinuation.

Hospice

Group	Value	95% CI
All Eligible Participants	7

Toxicity

Group	Value	95% CI
All Eligible Participants	13

Death

Group	Value	95% CI
All Eligible Participants	15

Progression

Group	Value	95% CI
All Eligible Participants	55

Decline in performance status

Group	Value	95% CI
All Eligible Participants	1

Participant choice

Group	Value	95% CI
All Eligible Participants	1

Physician choice

Group	Value	95% CI
All Eligible Participants	1

Unknown

Group	Value	95% CI
All Eligible Participants	3

Duration of Therapy (DOT) Primary · Alectinib or post-alectinib treatment initiation till its discontinuation or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study

DOT was defined as duration of time between alectinib or post-alectinib treatment initiation and discontinuation as documented in the iKM EHR database. Participants who did not have evidence of discontinuation, starting new therapy, or whose last prescription date was less than (\<) 30 days from the end of the study period, were censored at last visit date or end of study period.

Group	Value	95% CI
All Eligible Participants	23.9	18.2 – 31.9

Overall Survival (OS) Primary · From start of treatment until date of death or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study

OS was defined as the interval between treatment and the date of death (any cause) as documented in the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first.

Group	Value	95% CI
All Eligible Participants	46.3	36.6 – NA

Progression Free Survival (PFS) Primary · From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study

PFS was measured from the initiation of the treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date.

Group	Value	95% CI
All Eligible Participants	41.4	20.1 – NA

Sponsor's own description

This study aims to understand patient profiles, treatment patterns, and clinical outcomes among ALK-positive NSCLC patients treated with alectinib, and post-alectinib treatment patterns and outcomes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.