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

Completed

• Conditions: Non-Small-Cell Lung Carcinoma
• Interventions: Drug: Alectinib

• Registration Number: NCT04351334
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-27
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. Patients with a documented diagnosis of NSCLC.
2. Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC.
3. Patients who received treatment with alectinib during the study identification period, including those who initiated alectinib prior (index date-1) to the start of the study identification period.
4. During the study observation period, patients observed with at least 2 visits after the index date-1.

Exclusion Criteria

1. Receipt of treatment indicated for another primary cancer or diagnosis of another primary cancer (with the exception of non-melanotic skin cancer), within 5 years of index date-1 will be excluded.
2. Patients enrolled in clinical trials prior to receiving alectinib during the study ID period (index date-1), will be included and flagged in the analysis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with ALK-positive NSCLC	Alectinib	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence	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.
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation	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.
Duration of Therapy (DOT)	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.
Overall Survival (OS)	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.
Progression Free Survival (PFS)	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.

Trial Locations

Locations (1)

Pfizer Inc; 🇺🇸 New York, New York, United States